scholarly journals Prevention of dementia using mobile phone applications (PRODEMOS): protocol for an international randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e049762
Author(s):  
Esmé Eggink ◽  
Melanie Hafdi ◽  
Marieke P Hoevenaar-Blom ◽  
Manshu Song ◽  
Sandrine Andrieu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Individual Risk ◽  
Dementia Risk ◽  
Mobile Phone Applications ◽  
Randomised Controlled ◽  
The Uk ◽  
Medical University

IntroductionProfiles of high risk for future dementia are well understood and are likely to concern mostly those in low-income and middle-income countries and people at greater disadvantage in high-income countries. Approximately 30%–40% of dementia cases have been estimated to be attributed to modifiable risk factors, including hypertension, smoking and sedentary lifestyle. Tailored interventions targeting these risk factors can potentially prevent or delay the onset of dementia. Mobile health (mHealth) improves accessibility of such prevention strategies in hard-to-reach populations while at the same time tailoring such approaches. In the current study, we will investigate the effectiveness and implementation of a coach-supported mHealth intervention, targeting dementia risk factors, to reduce dementia risk.Methods and analysisThe prevention of dementia using mobile phone applications (PRODEMOS) randomised controlled trial will follow an effectiveness–implementation hybrid design, taking place in the UK and China. People are eligible if they are 55–75 years old, of low socioeconomic status (UK) or from the general population (China); have ≥2 dementia risk factors; and own a smartphone. 2400 participants will be randomised to either a coach-supported, interactive mHealth platform, facilitating self-management of dementia risk factors, or a static control platform. The intervention and follow-up period will be 18 months. The primary effectiveness outcome is change in the previously validated Cardiovascular Risk Factors, Ageing and Incidence of Dementia dementia risk score. The main secondary outcomes include improvement of individual risk factors and cost-effectiveness. Implementation outcomes include acceptability, adoption, feasibility and sustainability of the intervention.Ethics and disseminationThe PRODEMOS trial is sponsored in the UK by the University of Cambridge and is granted ethical approval by the London—Brighton and Sussex Research Ethics Committee (reference: 20/LO/01440). In China, the trial is approved by the medical ethics committees of Capital Medical University, Beijing Tiantan Hospital, Beijing Geriatric Hospital, Chinese People’s Liberation Army General Hospital, Taishan Medical University and Xuanwu Hospital. Results will be published in a peer-reviewed journal.Trial registration numberISRCTN15986016.

scholarly journals A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India and the UK: a randomised controlled trial

Diabetologia ◽  
2020 ◽  
Vol 63 (3) ◽  
pp. 486-496 ◽  
Author(s):  
Arun Nanditha ◽  
Hazel Thomson ◽  
Priscilla Susairaj ◽  
Weerachai Srivanichakorn ◽  
Nick Oliver ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Randomised Controlled Trial ◽  
Medical Research ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Text Messages ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
The Uk

Abstract Aims/hypothesis This randomised controlled trial was performed in India and the UK in people with prediabetes to study whether mobile phone short message service (SMS) text messages can be used to motivate and educate people to follow lifestyle modifications, to prevent type 2 diabetes. Methods The study was performed in people with prediabetes (n = 2062; control: n = 1031; intervention: n = 1031) defined by HbA1c ≥42 and ≤47 mmol/mol (≥6.0% and ≤6.4%). Participants were recruited from public and private sector organisations in India (men and women aged 35–55 years) and by the National Health Service (NHS) Health Checks programme in the UK (aged 40–74 years without pre-existing diabetes, cardiovascular disease or kidney disease). Allocation to the study groups was performed using a computer-generated sequence (1:1) in India and by stratified randomisation in permuted blocks in the UK. Investigators in both countries remained blinded throughout the study period. All participants received advice on a healthy lifestyle at baseline. The intervention group in addition received supportive text messages using mobile phone SMS messages 2–3 times per week. Participants were assessed at baseline and at 6, 12 and 24 months. The primary outcome was conversion to type 2 diabetes and secondary outcomes included anthropometry, biochemistry, dietary and physical activity changes, blood pressure and quality of life. Results At the 2 year follow-up (n = 2062; control: n = 1031; intervention: n = 1031), in the intention-to-treat population the HR for development of type 2 diabetes calculated using a discrete-time proportional hazards model was 0.89 (95% CI 0.74, 1.07; p = 0.22). There were no significant differences in the secondary outcomes. Conclusions/interpretation This trial in two countries with varied ethnic and cultural backgrounds showed no significant reduction in the progression to diabetes in 2 years by lifestyle modification using SMS messaging. Trial registration The primary study was registered on www.ClinicalTrials.gov (India, NCT01570946; UK, NCT01795833). Funding The study was funded jointly by the Indian Council for Medical Research and the UK Medical Research Council.

scholarly journals Uptake and effectiveness of a tailor-made online lifestyle programme targeting modifiable risk factors for dementia among middle-aged descendants of people with recently diagnosed dementia: study protocol of a cluster randomised controlled trial (Demin study)

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e039439
Author(s):  
Joyce Vrijsen ◽  
Ameen Abu-Hanna ◽  
Els LM Maeckelberghe ◽  
Peter Paul De Deyn ◽  
Andrea F de Winter ◽  
...  
Keyword(s):  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Lifestyle Advice ◽  
Cluster Randomised ◽  
Dementia Risk ◽  
Memory Clinics ◽  
Randomised Controlled ◽  
Lifestyle Programme

IntroductionDescendants of patients with dementia have a higher risk to develop dementia. This study aims to investigate the uptake and effectiveness of an online tailor-made lifestyle programme for dementia risk reduction (DRR) among middle-aged descendants of people with recently diagnosed late-onset dementia.Methods and analysisDemin is a cluster randomised controlled trial, aiming to include 21 memory clinics of which 13 will be randomly allocated to the passive (poster and flyer in a waiting room) and 8 to the active recruitment strategy (additional personal invitation by members of the team of the memory clinic). We aim to recruit 378 participants (40–60 years) with a parent who is recently diagnosed with Alzheimer’s disease or vascular dementia at one of the participating memory clinics. All participants receive a dementia risk assessment (online questionnaire, physical examination and blood sample) and subsequently an online tailor-made lifestyle advice regarding protective (Mediterranean diet, low/moderate alcohol consumption and high cognitive activity) and risk factors (physical inactivity, smoking, loneliness, cardiovascular diseases (CVD), hypertension, high cholesterol, diabetes, obesity, renal dysfunction and depression) for dementia. The primary outcome is the difference in uptake between the two recruitment strategies. Secondary outcomes are change(s) in (1) the Lifestyle for Brain Health score, (2) individual health behaviours, (3) health beliefs and attitudes towards DRR and (4) compliance to the tailor-made lifestyle advice. Outcomes will be measured at 3, 6, 9 and 12 months after baseline. The effectiveness of this online tailor-made lifestyle programme will be evaluated by comparing Demin participants to a matched control group (lifelines cohort).Ethics and disseminationThis study has been approved by the Dutch Ministry of Health, Welfare and Sport according to the Population Screening Act. All participants have to give online informed consent using SMS-tan (transaction authentication number delivered via text message). Findings will be disseminated through peer-reviewed journals and (inter)national conferences.Trial registration numberNTR7434.

Protocol for a feasibility randomised controlled trial comparing cognitive functional therapy with usual physiotherapy care in people with persistent low back pain

2021 ◽  
pp. 1-14
Author(s):  
Christopher Newton ◽  
Gurpreet Singh ◽  
David Nolan ◽  
Vicky Booth ◽  
Claire Diver ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Low Back ◽  
Functional Therapy ◽  
Randomised Controlled ◽  
The Uk ◽  
Feasibility Rct

BACKGROUND: Combined physical and psychological programmes (CPPP) are recommended for people with disabling low back pain (LBP). Cognitive Functional Therapy (CFT) is a physiotherapist-led low intensity CPPP with positive effects in previous studies. The clinical and cost effectiveness of CFT has not previously been evaluated in a randomised controlled trial (RCT) in the United Kingdom (UK) National Health Service (NHS). Before a definitive RCT can be completed it is necessary to determine if completing such a study is possible. PURPOSE: To determine the feasibility of completing a definitive RCT, that will evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care for people with persistent LBP in the UK NHS. METHODS: A pragmatic two-arm parallel feasibility RCT comparing CFT with usual physiotherapy care for people with persistent LBP will be completed. Sixty participants will be randomly allocated to receive CFT or usual physiotherapy care. The primary outcome will be feasibility of completing a definitive RCT. Participant reported outcome measures will be recorded at baseline, three, six and twelve-month follow-up, including disability, pain intensity, quality of life and psychosocial function. Data will be analysed descriptively. A qualitative process evaluation will explore the acceptability of the research processes and interventions. DISCUSSION: The rationale and methodological design of a mixed methods feasibility RCT is presented. This study aims to inform the planning, design and completion of a future definitive RCT in the UK NHS. The results will be disseminated through peer reviewed open access journal publication.

scholarly journals Swāsthya, an integrated chronic condition management programme for families of patients with hypertension and diabetes mellitus: a study protocol for a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
M D Saju ◽  
Bindiya M Varghese ◽  
Lorane Scaria ◽  
Anuja Maria Benny ◽  
Shilpa V Yohannan ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Social Cohesion ◽  
Chronic Conditions ◽  
Chronic Condition ◽  
Controlled Trial ◽  
Risk Groups ◽  
Care Model ◽  
Randomised Controlled

Abstract Background Kerala is known as the diabetes mellitus (DM) and hypertension (HTN) capital of the world, thus compelling health professionals to model strategies, addressing their social, behavioural, and cognitive risk factors and eliminating various barriers to management. This paper describes the protocol of our study that aims to examine the effectiveness and sustainability of an integrated care model for the management of chronic conditions and their risk factors through a family-based intervention. The proposed care model targets to modify systems and processes that predispose to chronic conditions by enhancing social cohesion and social networks, preventing lifestyle risks, developing iterative cognitive interventions, and engaging the family into customised treatment adherence strategies navigated by community health social workers (CHSWs). Methods A cluster randomised controlled trial (RCT) in selected participants will be conducted involving additional assessments prior to the baseline assessment. The assessment will identify and categorise patients into four risk groups, namely behavioural, social, cognitive, and multiple, based on dominant risks identified. Eligible participants will be randomly allocated (at a ratio of 1:1) into the intervention or control arm. The intervention arm will receive social, behavioural, and cognitive or multiple interventions corresponding to the identified risk groups, whereas the control arm will receive general intervention. Both the groups will be followed up at 6 months and 12 months post baseline to measure outcomes. The primary outcome will be the control of HTN and DM, and secondary outcomes include decreased depression and anxiety and improved functioning, social cohesion, and social network linkages. The sustainability and scalability of this intervention will be assessed through cost effectiveness, acceptability, and user friendliness of the integrated approach by performing a qualitative evaluation. Discussion This RCT will inform the potential paradigm shift from a medical model of chronic condition management to a multidimensional, multisystem, and multidisciplinary convergence model navigated by CHSWs. Such a model is not currently considered in the management of chronic conditions in Kerala. Trial registration Trial has been prospectively registered on Clinical Trial Registry of India- CTRI/2020/12/029474 on 1st December 2020.

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