Using mobile phone technology to treat alcohol use disorder: study protocol for a randomized controlled trial

Background

A primary concern within the healthcare system is to make treatment more accessible as well as attractive for the great majority of alcohol-dependent people who feel reluctant to participate in the treatment programs available. This paper presents the protocol for a randomized controlled trial (RCT) to test the efficacy of two different technical devices (mobile phone application and breathalyzer) on alcohol consumption.

Methods

The study is a three-armed RCT with follow-ups 3 and 6 months after randomization. In total, 375 adults (age 18+ years) diagnosed with alcohol use disorder (AUD) will be invited to participate in a 3-month intervention. The primary outcome is the number of days with heavy drinking, defined as four or more standard drinks (12 g alcohol/drink) and measured by the timeline follow back (TLFB) and Alcohol Use Disorder Identification Test (AUDIT) instruments at 3-month and 6-month follow-up. Secondary outcome measures include weekly alcohol consumption, measured by the TLFB, AUDIT, and phosphatidylethanol in blood values at 3-month and 6-month follow-up (number of days with blood alcohol concentration levels exceeding 60 mg/100 ml).

Discussion

Improving ways of collecting data on alcohol consumption, as well as the treatment system with regards to AUD, is of vital importance. Mobile phone technology, with associated applications, is widely recognized as a potentially powerful tool in the prevention and management of disease. This study will provide unique knowledge regarding the use of new technology as instruments for measuring alcohol consumption and, also, as a possible way to decrease it.

Trial registration

ISRCTN, ISRCTN14515753. Registered on 31 May 2018.

     

Combining behavioral weight loss treatment and a commercial program: A randomized clinical trial

Objective:

To test the hypothesis that a novel weight loss approach that combined the fundamental components of professionally delivered behavioral weight loss (BWL) treatment with the existing Weight Watchers (WW) program would produce better weight losses than WW alone no differences were expected between the novel treatment and BWL alone.

Design and Methods:

Participants were 141 overweight and obese adults (90% women, 67% non‐White, mean age = 49.7 ± 9.2 years, mean body mass index = 36.2 ± 5.5 kg/m²) randomly assigned to 48 weeks of BWL, 48 weeks of WW, or 12 weeks of BWL followed by 36 weeks of WW [combined treatment (CT)]. Assessments were conducted at baseline and weeks 12, 24, and 48, with weight change as the primary outcome.

Results:

Linear mixed model analysis showed that 24‐week weight losses did not differ significantly between treatment groups; however, weight losses at 48 weeks were greater in the WW group (M = ?6.0 kg, standard error (SE) = 0.8) compared with the CT group (M = ?3.6 kg, SE = 0.8; P = 0.032), with BWL not significantly different from either (M = ?5.4 kg, SE = 0.8). Further, a greater proportion of WW participants lost 10% of baseline weight by 48 weeks compared with BWL or CT (36.7%, 13.0%, and 15.2%, respectively, P < 0.05).

Conclusion:

This study shows that the WW program can produce clinically meaningful weight losses and provides no evidence that adding brief BWL to the WW program improves outcome.

     

E-Rehabilitation an Internet and mobile phone based tailored intervention to enhance selfmanagement of Cardiovascular Disease: study protocol for a randomized controlled trial

ABSTRACT: BACKGROUND: Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a longitudinally tailored Internet- and mobile phone based intervention that is based on models of health behaviour, on the level of physical activity and the adherence to the intervention, as an extension of a face-to-face cardiac rehabilitation stay. METHODS: A parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters. DISCUSSION: The study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively involved in its design, and because of the use of Open-Source software, the intervention can easily and at low-cost be reproduced and expanded by others. Challenges are the recruitment in the elderly population and the possible underrepresentation of women in the study sample. Funding by Northern Norway Regional Health Authority. Trial registration Trial registry www.clinicaltrials.gov: NCT01223170.     

Facemasks, hand hygiene, and influenza among young adults: a randomized intervention trial

Limited vaccine availability and the potential for resistance to antiviral medications have led to calls for establishing the efficacy of non-pharmaceutical measures for mitigating pandemic influenza. Our objective was to examine if the use of face masks and hand hygiene reduced rates of influenza-like illness (ILI) and laboratory-confirmed influenza in the natural setting. A cluster-randomized intervention trial was designed involving 1,178 young adults living in 37 residence houses in 5 university residence halls during the 2007–2008 influenza season. Participants were assigned to face mask and hand hygiene, face mask only, or control group during the study. Discrete-time survival models using generalized estimating equations to estimate intervention effects on ILI and confirmed influenza A/B infection over a 6-week study period were examined. A significant reduction in the rate of ILI was observed in weeks 3 through 6 of the study, with a maximum reduction of 75% during the final study week (rate ratio [RR] = 0.25, [95% CI, 0.07 to 0.87]). Both intervention groups compared to the control showed cumulative reductions in rates of influenza over the study period, although results did not reach statistical significance. Generalizability limited to similar settings and age groups. Face masks and hand hygiene combined may reduce the rate of ILI and confirmed influenza in community settings. These non-pharmaceutical measures should be recommended in crowded settings at the start of an influenza pandemic.

Trail Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00490633","term_id":"NCT00490633"}}NCT00490633     

Alzheimer's disease multiple intervention trial (ADMIT): study protocol for a randomized controlled clinical trial

ABSTRACT: BACKGROUND: Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer's disease reduces patients' neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects' functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged [greater than or equal to]45 years who are diagnosed with possible or probable Alzheimer's disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study.Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer's disease compared to subjects treated in the control group. Outcomes The primary outcome is the Alzheimer's Disease Cooperative Studies Group Activities of Daily Living Scale; secondary outcome measures are two performance-based measures including the Short Physical Performance Battery and Short Portable Sarcopenia Measure. Outcome assessments for both the caregiver-reported scale and subjects' physical performance scales are completed in the subject's home. Randomization Eligible patient-care giver dyads will be stratified by clinic type and block randomized with a computer developed randomization scheme using a 1:1 allocation ratio. Blinding Single blinded. Research assistants completing the outcome assessments were blinded to the subjects' treatment group. Trial status Ongoing ClinicalTrial.Gov identifier NCT01314950; date of completed registration 10 March 2011; date first patient randomized 9 March 2011.     

(Cost)-effectiveness of a multi-component intervention for adults with epilepsy: study protocol of a Dutch randomized controlled trial (ZMILE study)

Background

In patients with epilepsy, poor adherence to anti-epileptic drugs has been shown to be the most important cause of poorly controlled epilepsy. Furthermore, it has been noted that the quality of life among patients with epilepsy can be improved by counseling and treatments aimed at increasing their self-efficacy and concordance, thus stimulating self-management skills. However, there is a need for evidence on the effectiveness of such programs, especially within epilepsy care. Therefore, we have developed a multi-component intervention (MCI) which combines a self-management/education program with e-Health interventions. Accordingly, the overall objective of this study is to assess the (cost)-effectiveness and feasibility of the MCI, aiming to improve self-efficacy and concordance in patients with epilepsy.

Methods

A RCT in two parallel groups will be conducted to compare the MCI with a control condition in epilepsy patients. One hundred eligible epilepsy patients will be recruited and allocated to either the intervention or control group. The intervention group will receive the MCI consisting of a self-management/education program of six meetings, including e-Health interventions, and will be followed for 12 months. The control group will receive care as usual and will be followed for 6 months, after which patients will be offered the possibility of participating in the MCI. The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) process evaluation. The primary outcome will be self-efficacy. Secondary outcomes include adherence, side effects, change in seizure severity & frequency, improved quality of life, proactive coping, and societal costs. Outcome assessments will be done using questionnaires at baseline and after 3, 6, 9, and 12 months (last two applicable only for intervention group).

Discussion

In times of budget constraints, MCI could be a valuable addition to the current healthcare provision for epilepsy, as it is expected that higher concordance and self-efficacy will result in reduced use of healthcare resources and an increased QOL. Accordingly, this study is aimed helping patients to be their own provider of health care, shifting epilepsy management from professionals to self-care by patients equipped with appropriate skills and tools.

Trial registration number

NTR4484.