JMIR Publications

ABSTRACT

Background:

Chronic pain (CP) and early cognitive decline (ECD) are costly and highly prevalent among older adults. CP and ECD commonly co-occur, exacerbate one another over time, and can accelerate the development and progression of Alzheimer’s Disease and Related Dementias. We developed the first mind-body activity program (Active Brains; AB) tailored to the needs of older adults with CP and ECD. Results from our previous research strongly support the feasibility of conducting AB remotely and provided evidence for improvements in outcomes.

Objective:

We are conducting a single blinded, NIH stage 2, randomized controlled trial (RCT) to establish the efficacy of AB versus a time- and dose-matched education control (Health Enhancement Program; HEP) in 260 participants in improving self-report and objective outcomes of physical, cognitive and emotional function. Primary outcome is improvement in multimodal physical function (self-report, performance and objective). Secondary outcomes are improvements in cognitive and emotional function. Here, we describe our methodology which was informed by “lessons learned” from the first year of the trial.

Methods:

Participants are identified and recruited through provider referrals, the Rally Research platform, social media, and community partnerships. Interested participants complete eligibility screening and electronic informed consent. Baselines include self-report, performance based (e.g., 6 minute walk test) and objective measures (e.g., Repeatable Battery for the Assessment of Neuropsychological Status). Participants are mailed a wrist-worn ActiGraph device to passively monitor objective function (e.g., steps) during the week between the baseline assessment and the start of the programs, which they continue to wear throughout the programs. After baseline, participants are randomized to either AB or HEP and complete 8 weekly remote group sessions with an MGH psychologist. Those randomized to AB receive a Fitbit to help reinforce increased activity. Assessments are repeated at post-intervention and 6-months follow-up. Co-primary outcomes are multimodal physical function (self-report, performance-based, objective). Secondary outcomes are cognitive function (self-report and objective), emotional function, and pain.

Results:

The trial is ongoing. We have recruited 37 participants across 4 cohorts. All 37 participants completed the baseline, 26 participants completed the post-test assessment, and 9 are actively enrolled in the intervention (total dropout = 5%). Session attendance (92.8%, including makeups) and watch adherence (93.5%, average across ActiGraph and Fitbit devices) have been excellent.

Conclusions:

We aim to establish the efficacy of the Active Brains program over a time and dose-matched control in a virtual trial, and test mechanisms through theoretically driven mediators and moderators. Findings will inform the development of a future multi-site effectiveness-implementation trial. Clinical Trial: NCT05373745