BACKGROUND AND OBJECTIVES: Chronic pain (CP) and cognitive decline (CD) are highly comorbid and debilitating among older adults. We iteratively developed Active Brains-Fitbit (AB-F), a group mind-body activity program aided by a Fitbit that is feasible and associated with improvements in physical, cognitive, and emotional functioning when delivered in-person to older adults with CP and CD. We adapted our intervention and methodology for remote delivery to bypass barriers to participation. Here we report on a feasibility randomized controlled trial of the virtual AB-F versus a Health Enhancement Program (HEP) educational control followed by qualitative exit interviews. RESEARCH DESIGN AND METHODS: Older adults (aged ≥60) with CP and CD (2 cohorts) completed 8 weeks of AB-F (n = 8) or HEP (n = 11). Study procedures were fully remote via live video. Quantitative analyses explored feasibility and acceptability markers and within-group improvements in outcomes. Qualitative analyses were primarily deductive using the Framework Method. RESULTS: AB-F met a priori set feasibility benchmarks, similar to our in-person pilot. Participation in AB-F was associated with preliminary signals of improvement in multimodal physical function, emotional function (anxiety), cognitive function, pain intensity, and coping (e.g., pain self-efficacy, catastrophizing). Participation in HEP was associated with smaller or negligible improvements. Exit interviews confirmed feasibility and satisfaction with our completely remote interventions and methodology. DISCUSSION AND IMPLICATIONS: Results provide evidence for the feasibility of our completely remote study and for initial markers of improvement after AB-F. The results will inform a fully powered remote efficacy trial. CLINICAL TRIAL REGISTRATION: NCT04044183.
BACKGROUND AND OBJECTIVES: Chronic pain (CP) and cognitive decline (CD) are highly comorbid and debilitating among older adults. We iteratively developed Active Brains-Fitbit (AB-F), a group mind-body activity program aided by a Fitbit that is feasible and associated with improvements in physical, cognitive, and emotional functioning when delivered in-person to older adults with CP and CD. We adapted our intervention and methodology for remote delivery to bypass barriers to participation. Here we report on a feasibility randomized controlled trial of the virtual AB-F versus a Health Enhancement Program (HEP) educational control followed by qualitative exit interviews. RESEARCH DESIGN AND METHODS: Older adults (aged ≥60) with CP and CD (2 cohorts) completed 8 weeks of AB-F (n = 8) or HEP (n = 11). Study procedures were fully remote via live video. Quantitative analyses explored feasibility and acceptability markers and within-group improvements in outcomes. Qualitative analyses were primarily deductive using the Framework Method. RESULTS: AB-F met a priori set feasibility benchmarks, similar to our in-person pilot. Participation in AB-F was associated with preliminary signals of improvement in multimodal physical function, emotional function (anxiety), cognitive function, pain intensity, and coping (e.g., pain self-efficacy, catastrophizing). Participation in HEP was associated with smaller or negligible improvements. Exit interviews confirmed feasibility and satisfaction with our completely remote interventions and methodology. DISCUSSION AND IMPLICATIONS: Results provide evidence for the feasibility of our completely remote study and for initial markers of improvement after AB-F. The results will inform a fully powered remote efficacy trial. CLINICAL TRIAL REGISTRATION: NCT04044183.
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