Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study

Abstract

Background Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, 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. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults. 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. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions. Methods This is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and 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 envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness). Results The trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants). Conclusions Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple d...

The Strategies for Quantitative and Qualitative Remote Data Collection: Lessons From the COVID-19 Pandemic

“…The Montreal Cognitive Assessment [ 13 ], a measure we previously used in our in-person study [ 14 ], has been adapted and validated for remote administration over live videoconferencing [ 15 , 16 ]. Accordingly, we developed a standardized protocol for applying the Montreal Cognitive Assessment audiovisual procedures, including mailing participants a paper with items that required drawing and instructing them to display the paper to the camera for us to screenshot over videoconferencing [ 17 ]. Our literature review also identified a validated, free-of-charge mobile app that uses GPS coordinates to measure the distance walked in 6 minutes to replace the 6-minute walk test (6MWT) [ 18 ] that we had previously conducted in our in-person study [ 14 ].…”

“…Our literature review also identified a validated, free-of-charge mobile app that uses GPS coordinates to measure the distance walked in 6 minutes to replace the 6-minute walk test (6MWT) [ 18 ] that we had previously conducted in our in-person study [ 14 ]. Before using the app with participants, we piloted the app and developed a standardized protocol to assist participants in downloading the app, using the app, and reporting the results [ 17 ].…”

“…Similarly, in our randomized controlled trial with older adults with chronic pain and cognitive decline, we considered the safety risks associated with asking participants to complete the 6MWT independently (eg, falls). Participants were asked to create a plan to complete the 6MWT on a familiar route at a designated date and time, with support from a friend or family member when possible [ 17 ].…”

“…In this strategy, a member of study staff can email participants the links to complete surveys on their own devices and schedule a time in which the group of participants joins a videoconferencing call to complete the measures at the same time. We use this strategy in our randomized controlled trial for older adults with chronic pain and cognitive decline [ 17 ]. Participants in a group video call are supported in navigating to their email to open the secure link to complete the questionnaires.…”

Adaptation of a Live Video Mind–Body Program to a Web-Based Platform for English-Speaking Adults With Neurofibromatosis: Protocol for the NF-Web Study

“…For each open pilot, we aim to optimize the feasibility and acceptability of NF-Web and explore the quantitative outcomes. We hypothesize that the final iteration of NF-Web will meet the a priori set feasibility and acceptability benchmarks [ 8 - 10 ]. We also hypothesize that participation in NF-Web will be associated with improvement in quantitative outcomes from baseline to posttest.…”