ABSTRACT
BACKGROUND: Large-scale trials of multidomain interventions show that modifying lifestyle and psychological risk factors can slow cognitive decline. We aim to determine if a lower intensity, personally tailored secondary dementia prevention programme for older people with subjective or mild objective memory decline, informed by behaviour change theory, reduces cognitive decline over 2 years. METHODS: A multi-site, single-blind randomised controlled trial recruiting 704 older adults at high dementia risk due to mild cognitive impairment (MCI) or subjective cognitive decline (SCD). Participants are randomised using 1:1 allocation ratio to the APPLE Tree intervention versus control arm (dementia prevention information), stratified by site. The intervention explores and implements strategies to promote healthy lifestyle, increase pleasurable activities and social connections and improve long-term condition self-management. Two facilitators trained and supervised by a clinical psychologist deliver ten, 1-h group video call sessions over 6 months (approximately every fortnight), video-call 'tea breaks' (less structured, facilitated social sessions) in intervening weeks and individual goal-setting phone calls every 2 weeks. From 6 to 12 months, participants meet monthly for 'tea breaks', with those not attending receiving monthly goal-setting phone calls. Participants receive a food delivery, pedometer and website access to cognitive training and information about lifestyle modification. Follow-ups for all outcome measures are at 12 and 24 months. The primary outcome is cognition (Neuropsychological Test Battery (NTB) score) at 24 months. Secondary outcomes are quality of life, cost per quality-adjusted life year (QALY) and wellbeing and lifestyle factors the intervention targets (diet, vascular risk, body weight, activity, sleep, anxiety, depression, social networks and loneliness, alcohol intake and smoking). Participants from purposively selected sites participate in qualitative process evaluation interviews, which will be analysed using thematic analytic methods. DISCUSSION: If effective, the intervention design, involving remote delivery and non-clinical facilitators, would facilitate intervention roll-out to older people with memory concerns. TRIAL REGISTRATION: ISRCTN17325135 . Registration date 27 November 2019.
Subject(s)
Dementia , Malus , Aged , Cost-Benefit Analysis , Humans , Life Style , Quality of Life , Single-Blind Method , Tea , TechnologyABSTRACT
Background: With COVID-19, online opportunities to support families living with dementia are becoming increasingly important. However, academic institutions are typically not prepared to develop and test online platforms. We present a case study to describe steps for creating an infrastructure to test an online platform, WeCareAdvisor (WCA). WCA provides caregivers disease education and tailored strategies to manage dementia-related behavioral symptoms using the DICE Approach. WCA was previously tested in a small, randomized trial demonstrating positive caregiver outcomes. To advance its evidence-base, WCA is being tested in a NIA-funded Stage III efficacy trial with a national sample of 326 caregivers. Method(s): To test WCA, an infrastructure in the academic institution had to be created to address HIPAA compliance, privacy considerations, integrate user and developer input, and support rigorous trial methodologies. Through key informant interviews and literature reviews, we established a six-step process: 1) Identifying and engaging key stakeholders (legal, Information Technology offices, research team, software company);2) Creating software development agreement with stakeholder input;3) Detailing scope of work and an oversight structure of software company, 4) Developing formal agreements with the software company, 5) Conducting security assessments with university IT offices;and 6) Establishing formal vendor status of the software company. This also necessitated new roles and responsibilities of research team members. Result(s): The six-step process was labor intensive, transpired over 12 months, and involved over 15 iterative meetings with investigators, project staff, and stakeholders. Careful coordination of stakeholders to provide practical and iterative guidance at each of the six steps was essential. Deliberations resulted in app store access, URLs and domains, and compliance and privacy statements reviewed and approved by various university offices, and then launching WCA on app stores for access by study participants. Conclusion(s): Researchers and academic institutions have varying levels of understanding and readiness to engage in infrastructure development to rigorously test online platforms. Our approach resulted in an effective infrastructure for testing WCA which can be used by other researchers. Development of an infrastructure requires new skills for investigators, engaging multiple stakeholders, appropriately budgeting for this activity, and allocating sufficient start-up time. Copyright © 2022 the Alzheimer's Association.