JMIR Publications

ABSTRACT

Background:

Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, highly prevalent among older adults, and worsen each other over time. We are iteratively developing Active-Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind–body skills and gradual increases in step count aided by a Fitbit. AB-F has demonstrated feasibility, acceptability, and signals of improvement in emotional, physical, and cognitive function when delivered in-person to this population.

Objective:

We are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (Health Enhancement Program; HEP) in older adults with CP and CD. Due to COVID-19 and qualitative feedback from former participants, both programs are delivered in an entirely virtual format via live video (Zoom). Here, we describe our virtual study protocol, manualized treatments, evaluation plan, and study design. We will evaluate feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive function.

Methods:

This is a single-blind pilot RCT. Participants are randomized to one of two programs: AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and IRB-approved flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate sealed envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via secure live video. Participants complete self-report and performance-based (6-minute walk test, Montreal Cognitive Assessment) outcome measures via live video at baseline and post-intervention. Primary outcomes are a-priori set feasibility (recruitment, quantitative measures, adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional function, as well as intervention targets (social function, pain intensity, pain-specific coping, mindfulness).

Results:

The trial is ongoing. We have recruited 21 participants (10 AB-F, 11 HEP) across two rounds. Only two participants have withdrawn (1 before baseline, 1 before first session). All 19 remaining participants have completed the baseline. In the first round, attendance is high (11/12 completed all 4 sessions so far) and AB-F participants are adherent to their Fitbit and step goals (5/6).

Conclusions:

Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention but need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind–body and activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for the virtual assessments and intervention delivery will inform treatment development for older adults generally and those with CP–CD specifically, during the COVID-19 pandemic and beyond. Clinical Trial: ClinicalTrial.gov NCT04044183