Community Occupational Therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID]) study: A single-blind,randomised controlled trial

BackgroundWe aimed to estimate the clinical effectiveness of Community Occupational Therapy for people with dementia and family carers–UK version (Community Occupational Therapy in Dementia–UK version [COTiD-UK]) relative to treatment as usual (TAU). We hypothesised that COTiD-UK would improve the ability of people with dementia to perform activities of daily living (ADL), and family carers’ sense of competence, compared with TAU.Methods and findingsThe study design was a multicentre, 2-arm, parallel-group, assessor-masked, individually randomised controlled trial (RCT) with internal pilot. It was conducted in 15 sites across England from September 2014 to January 2018. People with a diagnosis of mild to moderate dementia living in their own home were recruited in pairs with a family carer who provided domestic or personal support for at least 4 hours per week. Pairs were randomised to either receive COTiD-UK, which comprised 10 hours of occupational therapy delivered over 10 weeks in the person with dementia’s home or TAU, which comprised the usual local service provision that may or may not include standard occupational therapy. The primary outcome was the Bristol Activities of Daily Living Scale (BADLS) score at 26 weeks. Secondary outcomes for the person with dementia included the following: the BADLS scores at 52 and 78 weeks, cognition, quality of life, and mood; and for the family carer: sense of competence and mood; plus the number of social contacts and leisure activities for both partners. Participants were analysed by treatment allocated. A total of 468 pairs were recruited: people with dementia ranged from 55 to 97 years with a mean age of 78.6 and family carers ranged from 29 to 94 with a mean of 69.1 years. Of the people with dementia, 74.8% were married and 19.2% lived alone. Of the family carers, 72.6% were spouses, and 22.2% were adult children. On randomisation, 249 pairs were assigned to COTiD-UK (62% people with dementia and 23% carers were male) and 219 to TAU (52% people with dementia and 32% carers were male). At the 26 weeks follow-up, data were available for 364 pairs (77.8%). The BADLS score at 26 weeks did not differ significantly between groups (adjusted mean difference estimate 0.35, 95% CI −0.81 to 1.51; p = 0.55). Secondary outcomes did not differ between the groups. In total, 91% of the activity-based goals set by the pairs taking part in the COTiD-UK intervention were fully or partially achieved by the final COTiD-UK session. Study limitations include the following: Intervention fidelity was moderate but varied across and within sites, and the reliance on primarily proxy data focused on measuring the level of functional or cognitive impairment which may not truly reflect the actual performance and views of the person living with dementia.ConclusionsProviding community occupational therapy as delivered in this study did not improve ADL performance, cognition, quality of life, or mood in people with dementia nor sense of competence or mood in family carers. Future research should consider measuring person-centred outcomes that are more meaningful and closely aligned to participants’ priorities, such as goal achievement or the quantity and quality of activity engagement and participation.Trial RegistrationCurrent Controlled Trials ISRCTN10748953.

Jennifer Wenborn and colleagues investigate the effectiveness of community occupational therapy program in improving activities of daily living, cognition, and mood for people with dementia.     

The Stroke and Carer Optimal Health Program (SCOHP) to enhance psychosocial health: study protocol for a randomized controlled trial

BackgroundStroke is a leading cause of disability and distress, and often profoundly affects the quality of life of stroke survivors and their carers. With the support of carers, many stroke survivors are returning to live in the community despite the presence of disability and ongoing challenges. The sudden and catastrophic changes caused by stroke affects the mental, emotional and social health of both stroke survivors and carers. The aim of this study is to evaluate a Stroke and Carer Optimal Health Program (SCOHP) that adopts a person-centred approach and engages collaborative therapy to educate, support and improve the psychosocial health of stroke survivors and their carers.MethodsThis study is a prospective randomised controlled trial. It will include a total of 168 stroke survivors and carers randomly allocated into an intervention group (SCOHP) or a control group (usual care). Participants randomised to the intervention group will receive nine (8 + 1 booster) sessions guided by a structured workbook. The primary outcome measures for stroke survivors and carers will be health-related quality of life (AQoL-6D and EQ-5D) and self-efficacy (GSE). Secondary outcome measures will include: anxiety and depression (HADS); coping (Brief COPE); work and social adjustment (WSAS); carer strain (MCSI); carer satisfaction (CASI); and treatment evaluation (TEI-SF and CEQ). Process evaluation and a health economic cost analysis will also be conducted.DiscussionWe believe that this is an innovative intervention that engages the stroke survivor and carer and will be significant in improving the psychosocial health, increasing independence and reducing treatment-related costs in this vulnerable patient-carer dyad. In addition, we expect that the intervention will assist carers and stroke survivors to negotiate the complexity of health services across the trajectory of care and provide practical skills to improve self-management.

Trial registration

ACTRN12615001046594. Registered on 7 October 2015.     

Cost-Effectiveness of a Specialist Geriatric Medical Intervention for Frail Older People Discharged from Acute Medical Units: Economic Evaluation in a Two-Centre Randomised Controlled Trial (AMIGOS)

BackgroundPoor outcomes and high resource-use are observed for frail older people discharged from acute medical units. A specialist geriatric medical intervention, to facilitate Comprehensive Geriatric Assessment, was developed to reduce the incidence of adverse outcomes and associated high resource-use in this group in the post-discharge period.ObjectiveTo examine the costs and cost-effectiveness of a specialist geriatric medical intervention for frail older people in the 90 days following discharge from an acute medical unit, compared with standard care.MethodsEconomic evaluation was conducted alongside a two-centre randomised controlled trial (AMIGOS). 433 patients (aged 70 or over) at risk of future health problems, discharged from acute medical units within 72 hours of attending hospital, were recruited in two general hospitals in Nottingham and Leicester, UK. Participants were randomised to the intervention, comprising geriatrician assessment in acute units and further specialist management, or to control where patients received no additional intervention over and above standard care. Primary outcome was incremental cost per quality adjusted life year (QALY) gained.ResultsWe undertook cost-effectiveness analysis for 417 patients (intervention: 205). The difference in mean adjusted QALYs gained between groups at 3 months was -0.001 (95% confidence interval [CI]: -0.009, 0.007). Total adjusted secondary and social care costs, including direct costs of the intervention, at 3 months were £4412 (€5624, $6878) and £4110 (€5239, $6408) for the intervention and standard care groups, the incremental cost was £302 (95% CI: 193, 410) [€385, $471]. The intervention was dominated by standard care with probability of 62%, and with 0% probability of cost-effectiveness (at £20,000/QALY threshold).ConclusionsThe specialist geriatric medical intervention for frail older people discharged from acute medical unit was not cost-effective. Further research on designing effective and cost-effective specialist service for frail older people discharged from acute medical units is needed.

Trial Registration

ISRCTN registry ISRCTN21800480 http://www.isrctn.com/ISRCTN21800480     

Comparación de los libros de historia de vida digitales y convencionales sobre el estado de ánimo,la comunicación,la cognición y la calidad de vida en personas con demencia en residencias: un estudio piloto

IntroductionPerson-centered care (PCC) includes life story, a form of reminiscence therapy that can be useful in the treatment of dementia. We compared the efficacy of using a digital or conventional life story book (LSB) on depressive symptoms, communication, cognition, and quality of life.Material and methodsThirty one persons with dementia living in 2 PCC nursing homes were randomly assigned to receive reminiscence therapy based on the Neural Actions digital LSB (n = 16) or a conventional LSB (n = 15). Both groups performed 2 weekly sessions of 45 min for 5 weeks. Depressive symptoms were evaluated with the Cornell scale (CSDD); communication with the Holden scale (HCS), cognition with the Mini Mental State Examination (MMSE) and quality of life with the quality of life scale for Alzheimer's (QoL-AD). The results were analyzed using ANOVA of repeated measures with the jamovi 2.3 program.ResultsBoth LSB improved communication skills (η² = 0.115; p < 0.001), with no differences between groups. No effects on quality of life, cognition, or mood were found.ConclusionsIn PCC centres digital or conventional LSB can be useful in the treatment of people with dementia by facilitating communication. Its role on quality of life, cognition or mood is uncertain.     

Effect of a training programme to reduce stress in carers of patients with dementia.

OBJECTIVE--To reduce the psychological stress and improve the skills in coping of people who care for relatives with dementia. DESIGN--Assessment and suitability of carers by questionnaire; assessment of patients and carers in a hospital outpatient clinic; allocation to groups according to date of application to study. Linkage of groups of four carers and programme coordinator by telephone conference calls over 12 months after programmes. Reassessment at three, six, 12, and, for those in the "wait list" group, 18 months. SETTING--The programmes were conducted in the psychiatry unit of a Sydney teaching hospital. SUBJECTS--Eligible patients were less than 80 years old, had mild to moderate dementia, and lived at home with their carer. Of the 96 patient-carer pairs in the study, 33 were in the dementia carers'' programme group, 31 were in the memory retraining group, and 32 were in the wait list group. INTERVENTIONS--Carers in the dementia carers'' programme received training in coping with the difficulties of looking after patients with dementia while the patients had sessions in subjects such as memory retraining. In the memory retraining programme patients were admitted and received the patient component of the carers'' programme while their carers had 10 days'' respite. In the wait list group carers waited six months before undertaking the carers'' programme. MAIN OUTCOME MEASURES--Effect of the programmes on carers'' general health questionnaire scores and the rate of placement of patients in institutions. RESULTS--At 12 months'' follow up the carers'' programme had resulted in significantly lower psychological stress among carers than the memory retraining programme (mean (SD) general health questionnaire scores at 0 months were 6.31 (6.23) and 3.60 (6.25) respectively, and at 12 months were 4.69 (5.58) and 7.40 (9.39); p less than 0.05.) In the wait list group distress scores remained stable, even after the carers and patients had undertaken the carers'' programme. Patients deteriorated over 12 months regardless of group allocation, but at 30 months, allowing for patients who died and could not be included in the analysis, 65% of patients in the carers'' programme group were still living at home compared with 26% in the memory retraining programme group. CONCLUSION--The intensive intervention programme described for carers of patients with dementia can reduce the psychological morbidity of the carer and delay the placement of the patient in an institution without increasing the use of health services by either patient or carer.     

Advance Care Planning in Dementia: Do Family Carers Know the Treatment Preferences of People with Early Dementia?

MethodsA cross-sectional study interviewing 60 dyads (a person with early dementia and preserved capacity and their family carer) each completing a modified LSPQ. We assessed how closely carers’ choices resembled the PWD’s preferences for treatment in three proposed health states: the here and now; severe stroke with coma; terminal cancer. Agreement between the PWD and their family carer responses was assessed using Kappa and Prevalence-Adjusted Bias-Adjusted Kappa (PABAK) statistics. We examined whether carer burden and distress, and relationship quality, influenced agreement.ResultsIn interviews PWD were able to indicate their treatment preferences across all three scenarios. In the here-and-now most wanted antibiotics (98%), fewer cardio-pulmonary resuscitation (CPR) (50%) and tube feeding (47%). In severe stroke and coma antibiotics remained the more preferred treatment (88%), followed by CPR (57%) and tube feeding (30%). In advanced cancer PWD expressed lower preferences for all treatments (antibiotics 68%; CPR 50%; tube feeding 37%). Carers’ choices were similar to the PWDs’ preferences in the here-and-now (71% (k = 0.03; PABAK = 0.4) with less agreement for future hypothetical health states. In severe stroke and coma carers tended wrongly to suggest that the PWD preferred more intervention (antibiotic, 67%; k = -0.022; PABAK = -0.60; CPR, 73%; k = 0.20; PABAK = -0.20, tube feeding, 66%; k = 0.25; PABAK = -0.12). In advanced cancer the agreement between PWD and carers was low (antibiotics; k = -0.03; PABAK = -0.52; CPR, k = -0.07; PABAK = -0.45; tube feeding; k = 0.20; PABAK = -0.22). However, both PWD and carers showed marked uncertainty about their preferences for end of life treatment choices. Relationship quality, carer distress and burden had no influence on agreement.ConclusionsThis study is the first to have used the LSPQ with PWD in the UK to consider treatment options in hypothetical illness scenarios. Key finding are that family carers had a low to moderate agreement with PWD on preferences for end of life treatment. This underscores how planning for care at the end of life is beset with uncertainty, even when the carer and PWD perceive the care-giving/receiving relationship is good. Families affected by dementia may benefit from early and ongoing practical and emotional support to prepare for potential changes and aid decision making in the context of the realities of care towards the end of life.     

Impact of an Educational Intervention on Women's Knowledge and Acceptability of Human Papillomavirus Self-Sampling: A Randomized Controlled Trial in Cameroon

ObjectiveHuman papillomavirus (HPV) self-sampling (Self-HPV) may be used as a primary cervical cancer screening method in a low resource setting. Our aim was to evaluate whether an educational intervention would improve women''s knowledge and confidence in the Self-HPV method.MethodWomen aged between 25 and 65 years old, eligible for cervical cancer screening, were randomly chosen to receive standard information (control group) or standard information followed by educational intervention (interventional group). Standard information included explanations about what the test detects (HPV), the link between HPV and cervical cancer and how to perform HPV self-sampling. The educational intervention consisted of a culturally tailored video about HPV, cervical cancer, Self-HPV and its relevancy as a screening test. All participants completed a questionnaire that assessed sociodemographic data, women''s knowledge about cervical cancer and acceptability of Self-HPV.ResultsA total of 302 women were enrolled in 4 health care centers in Yaoundé and the surrounding countryside. 301 women (149 in the “control group” and 152 in the “intervention group”) completed the full process and were included into the analysis. Participants who received the educational intervention had a significantly higher knowledge about HPV and cervical cancer than the control group (p<0.05), but no significant difference on Self-HPV acceptability and confidence in the method was noticed between the two groups.ConclusionEducational intervention promotes an increase in knowledge about HPV and cervical cancer. Further investigation should be conducted to determine if this intervention can be sustained beyond the short term and influences screening behavior.

Trials Registration

International Standard Randomised Controlled Trial Number (ISRCTN) Register ISRCTN78123709     

Exploring the Mechanisms of a Patient-Centred Assessment with a Solution Focused Approach (DIALOG+) in the Community Treatment of Patients with Psychosis: A Process Evaluation within a Cluster-Randomised Controlled Trial

Background

DIALOG+ is a new intervention to make routine community mental health meetings therapeutically effective. It involves a structured assessment of patient concerns and a solution-focused approach to address them. In a randomised controlled trial, DIALOG+ was associated with better subjective quality of life and other outcomes in patients with psychosis, but it was not clear how this was achieved. This study explored the possible mechanisms.

Methods

This was a mixed-methods process evaluation within a cluster-randomised controlled trial. Focus groups and interviews were conducted with patients and clinicians who experienced DIALOG+ and were analysed using thematic analysis. The content of DIALOG+ sessions was recorded and analysed according to (i) the type of actions agreed during sessions and (ii) the domains discussed. The subjective quality of life measure was analysed with mixed-effects models to explore whether the effect of DIALOG+ was limited to life domains that had been addressed in sessions or consistent across all domains.

Results

Four qualitative themes emerged regarding the mechanisms of DIALOG+: (1) a comprehensive structure; (2) self-reflection; (3) therapeutic self-expression; and (4) empowerment. Patients took responsibility for the majority of actions agreed during sessions (65%). The treatment effect on subjective quality of life was largest for living situation (accommodation and people that the patient lives with) and mental health. Two of these domains were among the three most commonly discussed in DIALOG+ sessions (accommodation, mental health, and physical health).

Conclusion

DIALOG+ initiates positive, domain-specific change in the areas that are addressed in sessions. It provides a comprehensive and solution-focused structure to routine meetings, encourages self-reflection and expression, and empowers patients. Future research should strengthen and monitor these factors.

Trial Registration

ISRCTN Registry ISRCTN34757603.     

Effectiveness of an Internet Intervention for Family Caregivers of People with Dementia: Results of a Randomized Controlled Trial

BackgroundThe World Health Organization stresses the importance of accessible and (cost)effective caregiver support, given the expected increase in the number of people with dementia and the detrimental impact on the mental health of family caregivers.MethodsThis study assessed the effectiveness of the Internet intervention ‘Mastery over Dementia’. In a RCT, 251 caregivers, of whom six were lost at baseline, were randomly assigned to two groups. Caregivers in the experimental group (N = 149) were compared to caregivers who received a minimal intervention consisting of e-bulletins (N = 96). Outcomes were symptoms of depression (Center for Epidemiologic Studies Depression Scale: CES-D) and anxiety (Hospital Anxiety and Depression Scale: HADS-A). All data were collected via the Internet, and an intention-to-treat analysis was carried out.ResultsAlmost all caregivers were spouses or children (in-law). They were predominantly female and lived with the care recipient in the same household. Age of the caregivers varied from 26 to 87 years. Level of education varied from primary school to university, with almost half of them holding a bachelor’s degree or higher. Regression analyses showed that caregivers in the experimental group showed significantly lower symptoms of depression (p = .034) and anxiety (p = .007) post intervention after adjustment for baseline differences in the primary outcome scores and the functional status of the patients with dementia. Effect sizes were moderate for symptoms of anxiety (.48) and small for depressive symptoms (.26).ConclusionsThe Internet course ‘Mastery over Dementia’ offers an effective treatment for family caregivers of people with dementia reducing symptoms of depression and anxiety. The results of this study justify further development of Internet interventions for family caregivers of people with dementia and suggest that such interventions are promising for keeping support for family caregivers accessible and affordable. The findings are even more promising because future generations of family caregivers will be more familiar with the Internet.

Trial Registration

Dutch Trial Register NTR-2051 www.trialregister.nl/trialreg/admin/rctview.asp?TC=2051     

Factors associated with self and informant ratings of the quality of life of people with dementia living in care facilities: a cross sectional study

Background

There is no consensus regarding the optimal approach to assessment of the quality of life of people with dementia. We undertook the present study to describe and determine the factors associated with ratings of the quality of life of a cohort of people with dementia living in a residential care facility.

Methodology/Principal Findings

351 people with dementia living in residential care facilities, and their staff and family informants participated in this cross sectional observational study. Quality of life was measured using self (Quality of Life in Alzheimer''s Disease [QoL-AD] scale), and informant (QoL-AD and Alzheimer''s Disease Related QoL Scale) reports. 226 people (64%) with dementia (median MMSE 17; 12–21) were able to self rate the QoL-AD scale and these subjects'' ratings were compared to ratings by staff and family. Both staff and family informant ratings of the QoL-AD underestimated self ratings (mean difference −7.8, 95% CI −8.8, −6.7 for staff rated QoL-AD; and mean difference −7.2, 95% CI −8.5, −6.0 for family rated QoL-AD). Self ratings of QoL were lower among people who were restrained, had fallen or had pain. Informant ratings of the QoL of the participants with dementia were consistently and significantly lower for people with severe cognitive impairment, who had fallen, had presence of neuropsychiatric symptoms, or where care giver distress was present. Documented restraint, reported pain and neuropsychiatric symptoms were independently associated with lower self rating of the QoL-AD in multivariate models. Cognitive impairment, case conferencing, hospitalizations and neuropsychiatric symptoms were found to be independently associated with staff rated ADRQL.

Conclusions

The majority of people with dementia living in residential care facilities can rate their own QoL. Informant ratings underestimate self ratings of QoL of people with dementia, and appear to be associated with factors which are not associated with self ratings.     

Depression and other psychiatric morbidity in carers of elderly people living at home.

OBJECTIVE--To describe the mental health of a community sample of carers of elderly people with dementia, depression, or physical disability and to compare that with the mental health of other adults living in the household and of those living alone. DESIGN--Assessment of psychiatric morbidity and physical disability with standardised questionnaire in randomly selected enumeration districts; subjects were interviewed at home. SETTING--London Borough of Islington. SUBJECTS--700 people aged > or = 65 and other coresidents. MAIN OUTCOME MEASURE--Depression measured with standardised interview. RESULTS--The prevalence of depression was not significantly higher in carers overall (15%) than in coresidents (11%). Being a woman carer was a significant predictor of psychiatric illness. Depression was more common in the carers of people with a psychiatric disorder than in coresidents (24% v 11%, P < 0.05) and in those living alone (19%). Depression was most common (47%) in women carers of people with dementia. CONCLUSION--The increase in psychiatric morbidity reported in carers of people with psychiatric disorders may reflect the lack of a confiding relationship.     

Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial

BackgroundSelf-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes.ConclusionsSupported telemonitoring resulted in clinically important improvements in control of glycaemia in patients with type 2 diabetes in family practice. Current Controlled Trials, registration number ISRCTN71674628.

Trial Registration

Current Controlled Trials ISRCTN 71674628     

Befriending carers of people with dementia: randomised controlled trial

Objective To evaluate the effectiveness of a voluntary sector based befriending scheme in improving psychological wellbeing and quality of life for family carers of people with dementia.Design Single blind randomised controlled trial.Setting Community settings in East Anglia and London.Participants 236 family carers of people with primary progressive dementia.Intervention Contact with a befriender facilitator and offer of match with a trained lay volunteer befriender compared with no befriender facilitator contact; all participants continued to receive “usual care.”Main outcome measures Carers’ mood (hospital anxiety and depression scale—depression) and health related quality of life (EuroQoL) at 15 months post-randomisation.Results The intention to treat analysis showed no benefit for the intervention “access to a befriender facilitator” on the primary outcome measure or on any of the secondary outcome measures.Conclusions In common with many carers’ services, befriending schemes are not taken up by all carers, and providing access to a befriending scheme is not effective in improving wellbeing.Trial registration Current Controlled Trials ISRCTN08130075.     

Programa de reminiscencia apoyado en inteligencia artificial y basado en el patrimonio cultural inmaterial dirigido a personas mayores: un estudio piloto

IntroductionTechnological applications are an innovative way of providing reminiscence therapy and must meet the users’ needs. Intangible cultural heritage as a basis for such therapy has not been explored yet. We evaluated the applicability of a new technological application supported by artificial intelligence for reminiscence therapy based on intangible cultural heritage aimed at older people.Material and methodsA prospective observational study was carried out with people aged 65 or over, without cognitive impairment and with mild and moderate cognitive impairment who attended six centers for older people in Spain and Portugal. Participants tested the first prototype of the individualized LONG-REMI program in four consecutive weekly sessions. The usability and satisfaction of the experience were evaluated using the VAS scale at the end of the intervention. Emotions were evaluated using the PANAS scale before and at the end of the intervention.ResultsData from 56 participants were analysed. For all participants, usability and satisfaction were highly perceived, with scores of 7.75±1.88 and 8.38±1.57, respectively. The positive affect subscale PANAS showed significant changes (28.86±8.88 before the intervention versus 36.70±9.43 post intervention, Z = −4.18, P = 0.000). There were no significant changes in the PANAS negative affect subscale.ConclusionsThe first prototype of the LONG-REMI technological application can be used by older people both with and without cognitive impairment. This has the potential to be an instrument for future cognitive therapies with stimulating activities and benefits for emotions.     

Effectiveness of a Universal Parental Support Programme to Promote Healthy Dietary Habits and Physical Activity and to Prevent Overweight and Obesity in 6-Year-Old Children: The Healthy School Start Study,a Cluster-Randomised Controlled Trial

ObjectiveTo develop and evaluate the effectiveness of a parental support programme to promote healthy dietary and physical activity habits and to prevent overweight and obesity in Swedish children.MethodsA cluster-randomised controlled trial was carried out in areas with low to medium socio-economic status. Participants were six-year-old children (n = 243) and their parents. Fourteen pre-school classes were randomly assigned to intervention (n = 7) and control groups (n = 7). The intervention lasted for 6 months and included: 1) Health information for parents, 2) Motivational Interviewing with parents and 3) Teacher-led classroom activities with children. Physical activity was measured by accelerometry, dietary and physical activity habits and parental self-efficacy through a questionnaire. Body weight and height were measured and BMI standard deviation score was calculated. Measurements were conducted at baseline, post-intervention and at 6-months follow-up. Group differences were examined using analysis of covariance and Poisson regression, adjusted for gender and baseline values.ResultsThere was no significant intervention effect in the primary outcome physical activity. Sub-group analyses showed a significant gender-group interaction in total physical activity (TPA), with girls in the intervention group demonstrating higher TPA during weekends (p = 0.04), as well as in sedentary time, with boys showing more sedentary time in the intervention group (p = 0.03). There was a significantly higher vegetable intake (0.26 servings) in the intervention group compared to the control group (p = 0.003). At follow-up, sub-group analyses showed a sustained effect for boys. The intervention did not affect the prevalence of overweight or obesity.ConclusionsIt is possible to influence vegetable intake in children and girls’ physical activity through a parental support programme. The programme needs to be intensified in order to increase effectiveness and sustain the effects long-term. These findings are an important contribution to the further development of evidence-based parental support programmes to prevent overweight and obesity in children.

Trial Registration

Controlled-trials.com ISRCTN32750699     

Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial

BackgroundOlder adults, including those with long-term conditions (LTCs), are vulnerable to social isolation. They are likely to have become more socially isolated during the Coronavirus Disease 2019 (COVID-19) pandemic, often due to advice to “shield” to protect them from infection. This places them at particular risk of depression and loneliness. There is a need for brief scalable psychosocial interventions to mitigate the psychological impacts of social isolation. Behavioural activation (BA) is a credible candidate intervention, but a trial is needed.Methods and findingsWe undertook an external pilot parallel randomised trial (ISRCTN94091479) designed to test recruitment, retention and engagement with, and the acceptability and preliminary effects of the intervention. Participants aged ≥65 years with 2 or more LTCs were recruited in primary care and randomised by computer and with concealed allocation between June and October 2020. BA was offered to intervention participants (n = 47), and control participants received usual primary care (n = 49). Assessment of outcome was made blind to treatment allocation. The primary outcome was depression severity (measured using the Patient Health Questionnaire 9 (PHQ-9)). We also measured health-related quality of life (measured by the Short Form (SF)-12v2 mental component scale (MCS) and physical component scale (PCS)), anxiety (measured by the Generalised Anxiety Disorder 7 (GAD-7)), perceived social and emotional loneliness (measured by the De Jong Gierveld Scale: 11-item loneliness scale). Outcome was measured at 1 and 3 months. The mean age of participants was aged 74 years (standard deviation (SD) 5.5) and they were mostly White (n = 92, 95.8%), and approximately two-thirds of the sample were female (n = 59, 61.5%). Remote recruitment was possible, and 45/47 (95.7%) randomised to the intervention completed 1 or more sessions (median 6 sessions) out of 8. A total of 90 (93.8%) completed the 1-month follow-up, and 86 (89.6%) completed the 3-month follow-up, with similar rates for control (1 month: 45/49 and 3 months 44/49) and intervention (1 month: 45/47and 3 months: 42/47) follow-up. Between-group comparisons were made using a confidence interval (CI) approach, and by adjusting for the covariate of interest at baseline. At 1 month (the primary clinical outcome point), the median number of completed sessions for people receiving the BA intervention was 3, and almost all participants were still receiving the BA intervention. The between-group comparison for the primary clinical outcome at 1 month was an adjusted between-group mean difference of −0.50 PHQ-9 points (95% CI −2.01 to 1.01), but only a small number of participants had completed the intervention at this point. At 3 months, the PHQ-9 adjusted mean difference (AMD) was 0.19 (95% CI −1.36 to 1.75). When we examined loneliness, the adjusted between-group difference in the De Jong Gierveld Loneliness Scale at 1 month was 0.28 (95% CI −0.51 to 1.06) and at 3 months −0.87 (95% CI −1.56 to −0.18), suggesting evidence of benefit of the intervention at this time point. For anxiety, the GAD adjusted between-group difference at 1 month was 0.20 (−1.33, 1.73) and at 3 months 0.31 (−1.08, 1.70). For the SF-12 (physical component score), the adjusted between-group difference at 1 month was 0.34 (−4.17, 4.85) and at 3 months 0.11 (−4.46, 4.67). For the SF-12 (mental component score), the adjusted between-group difference at 1 month was 1.91 (−2.64, 5.15) and at 3 months 1.26 (−2.64, 5.15). Participants who withdrew had minimal depressive symptoms at entry. There were no adverse events. The Behavioural Activation in Social Isolation (BASIL) study had 2 main limitations. First, we found that the intervention was still being delivered at the prespecified primary outcome point, and this fed into the design of the main trial where a primary outcome of 3 months is now collected. Second, this was a pilot trial and was not designed to test between-group differences with high levels of statistical power. Type 2 errors are likely to have occurred, and a larger trial is now underway to test for robust effects and replicate signals of effectiveness in important secondary outcomes such as loneliness.ConclusionsIn this study, we observed that BA is a credible intervention to mitigate the psychological impacts of COVID-19 isolation for older adults. We demonstrated that it is feasible to undertake a trial of BA. The intervention can be delivered remotely and at scale, but should be reserved for older adults with evidence of depressive symptoms. The significant reduction in loneliness is unlikely to be a chance finding, and replication will be explored in a fully powered randomised controlled trial (RCT).Trial registrationISRCTN94091479.

In a pilot randomised controlled trial, Simon Gilbody and colleagues present preliminary findings from a telephone delivered intervention (behavioural activation) designed to prevent depression and loneliness among socially isolated older people with long term conditions.     

An intervention to improve teacher well-being support and training to support students in UK high schools (the WISE study): A cluster randomised controlled trial

BackgroundTeachers are at heightened risk of poor mental health and well-being, which is likely to impact on the support they provide to students, and student outcomes. We conducted a cluster randomised controlled trial, to test whether an intervention to improve mental health support and training for high school teachers led to improved mental health and well-being for teachers and students, compared to usual practice. We also conducted a cost evaluation of the intervention.Methods and findingsThe intervention comprised (i) Mental Health First Aid training for teachers to support students; (ii) a mental health awareness session; and (iii) a confidential staff peer support service. In total 25 mainstream, non-fee-paying secondary schools stratified by geographical area and free school meal entitlement were randomly allocated to intervention (n = 12) or control group (n = 13) after collection of baseline measures. We analysed data using mixed-effects repeated measures models in the intention-to-treat population, adjusted for stratification variables, sex, and years of experience. The primary outcome was teacher well-being (Warwick-Edinburgh Mental Well-being Scale). Secondary outcomes were teacher depression, absence, and presenteeism, and student well-being, mental health difficulties, attendance, and attainment. Follow-up was at months 12 (T1) and 24 (T2). We collected process data to test the logic model underpinning the intervention, to aid interpretation of the findings. A total of 1,722 teachers were included in the primary analysis. Teacher well-being did not differ between groups at T2 (intervention mean well-being score 47.5, control group mean well-being score 48.4, adjusted mean difference −0.90, 95% CI –2.07 to 0.27, p = 0.130). The only effect on secondary outcomes was higher teacher-reported absence among the intervention group at T2 (intervention group median number of days absent 0, control group median number of days absent 0, ratio of geometric means 1.04, 95% CI 1.00 to 1.09, p = 0.042). Process measures indicated little change in perceived mental health support, quality of relationships, and work-related stress. The average cost of the intervention was £9,103 per school. The study’s main limitations were a lack of blinding of research participants and the self-report nature of the outcome measures.ConclusionsIn this study, we observed no improvements to teacher or student mental health following the intervention, possibly due to a lack of impact on key drivers of poor mental health within the school environment. Future research should focus on structural and cultural changes to the school environment, which may be more effective at improving teacher and student mental health and well-being.Trial registrationwww.isrctn.com ISRCTN95909211.

Using a cluster randomized study, Judi Kidger and colleagues study an intervention to improve teacher wellbeing support and training to support students in UK high schools (the WISE study).     

Effectiveness of family meetings for family caregivers on delaying time to nursing home placement of dementia patients: a randomized trial

Background

Interventions relieving the burden of caregiving may postpone or prevent patient institutionalization. The objective of this study was to determine whether a family meetings intervention was superior to usual care in postponing nursing home placement of patients with dementia.

Methods

A randomized multicenter trial was conducted among 192 patients with a clinical diagnosis of dementia living at home at enrolment and their primary family caregiver. Dyads of caregivers and patients were randomized to the family meetings intervention (n = 96) or usual care (n = 96) condition. The intervention consisted of two individual sessions with the primary caregiver and four family counseling sessions that included family members and friends. The primary outcome measure was the time until institutionalization of the patient. Intention-to-treat as well as per protocol analyses were performed. Survival analyses were carried out to evaluate the effectiveness of the intervention.

Results

During 18 months follow-up 23 of 96 relatives with dementia of caregivers in the intervention group and 18 of 96 relatives with dementia of caregivers in the usual care group were institutionalized. No significant difference between the intervention and the usual care group was found in time until institutionalization (adjusted hazard ratio (HR) 1.46, 95% confidence interval (CI) 0.78 to 2.74). The per-protocol analysis revealed no significant effect either (adjusted HR 0.57, 95% CI 0.21 to 1.57), although the number of placements among the adherers was relatively low (9.4%). A subgroup effect was found for patients’ age, with a significantly higher risk of institutionalization for ‘younger’ patients in the intervention group compared with the usual care group (adjusted HR = 4.94, 95% CI 1.10 to 22.13).

Conclusion

This family meetings intervention for primary caregivers of patients with dementia did not postpone patient institutionalization more than usual care.

Trial Registration: Controlled-Trials.com ISRCTN90163486

     

Caries incidence and increments in community-living older adults with and without dementia

Objectives: The Oral Health of Older Adults with Dementia was instigated in the late 1990s to quantify and compare coronal and root caries incidence and increments in community‐living older Australians with and without dementia. Methods: A longitudinal design was used to conduct dental inspections at baseline and one‐year, for two groups of randomly selected community‐living older adults ‐ one group of 116 people with dementia and a comparison group of 116 people without dementia. Results: At one‐year there were 103 dementia and 113(112 dentate) non‐dementia participants. Coronal and root surface caries incidence was higher for dementia participants (p<0.05). Dementia participants had higher coronal and root caries adjusted caries increments (ADJCI) (p<0.01). Both coronal and root ADJCI were evident in half of dementia participants, compared with one‐quarter of non‐dementia participants. Dementia participants with higher coronal ADJCI were those who had visited the dentist since baseline, who were taking neuroleptics with high anticholinergic adverse effects, and whose carer had high carer burden score (p<0.01). Dementia participants with higher root ADJCI were those needing assistance with oral hygiene care and whose carers had difficulties with oral hygiene care (p<0.05). Baseline characteristics predictive in linear regression for: (1) coronal caries increments among all participants were ‐ dementia participants, those with cognitive testing scores indicative of moderate‐severe dementia, those with private health insurance; (2) root caries increments among all participants were ‐ dementia participants, and those who had 1 decayed/filled root surface at baseline. Among dementia participants, being male was the baseline characteristic predictive in logistic regression for coronal caries increments, and having 1 decayed coronal surface was the baseline characteristic predictive for root caries increments. Conclusions: Coronal and root caries incidence and increments were significantly higher in the community‐living older adults with dementia over the one‐year follow‐up period. Dementia participants had high levels of coronal and root caries increments; characteristics related to high caries increments included sex (males), dementia severity (moderate‐severe), high carer burden, oral hygiene care difficulties, use of neuroleptic medication (with high anticholinergic adverse effects) and previous experience of caries.