Testing a digitally administered intervention to increase social participation, physical fitness, and health awareness among healthy older adults by means of tablet-based app use: study protocol of the SMART-AGE randomized controlled trial

BACKGROUND: Digital interventions for older adults may significantly extend preventive action to postpone disability and preserve health-related quality of life. However, more evidence is needed from multi-domain interventions using broad-scale objective and self-report assessments and intra-individual change data-analytical techniques. METHOD: SMART-AGE examines the effect of an app-based multilevel treatment designed to enhance social participation, physical fitness, and health awareness. The target population comprises healthy and community-dwelling adults 67 years and older with basic digital skills in two socially diverse communities. Treatment relies on an Android-based tablet computer, on which three apps offering interventions in the core areas of social participation, physical fitness, and health awareness are pre-installed. A feedback app designed to provide participants with a feedback option at any time is also offered. Participants are randomly assigned to three intervention arms and assessed at baseline and after 3 and 6 months. Arm 1 receives the full intervention, consisting of the social participation app, the physical fitness app, the health awareness app, and the feedback app. The health awareness app is available in months 4 to 6, meaning that participants receive the full three-app intervention only in the second half of the intervention period. Arm 2 receives the social participation app and the feedback app throughout the intervention. Arm 3 serves as an active control condition in that a stand-alone tablet with a low-dose introduction to publicly available standard apps is provided. The data protocol includes assessment of three primary outcome domains: social support and loneliness, motor capacity and physical performance, and health awareness and health locus of control. Potential moderators (e.g., cognitive function, depression) as well as various technology-oriented constructs (e.g., skills, acceptance) are also assessed. App use data are automatically collected across the full intervention interval in arms 1 and 2. Data management is conducted within a cloud-based REDCap architecture. Feedback recordings via the feedback app are collected in arms 1 and 2 and undergo qualitative analysis. DISCUSSION: The SMART-AGE intervention aims to enhance core domains of health-related quality of life in community-dwelling older adults through an app-based multi-domain intervention and a user-centered approach. TRIAL REGISTRATION: German-Clinical-Trials-Register, DRKS00034316. Registered 29-May-2024, https://drks.de/search/en/trial/DRKS00034316 . The study's design and hypotheses were also pre-registered in the Open Science Framework (OSF) prior to study enrollment ( https://doi.org/10.17605/OSF.IO/YQEBW , 2023-04-28).