Dataset Information

Live Video Mind-Body Program for Patients With Knee Osteoarthritis, Comorbid Depression, and Obesity: Development and Feasibility Pilot Study.

ABSTRACT:

Background

Knee osteoarthritis (KOA) is the most common joint disorder in the United States and a leading cause of disability. Depression and obesity are highly comorbid with KOA and accelerate knee degeneration and disability through biopsychosocial mechanisms. Mind-body physical activity programs can engage biological, mechanical, and psychological mechanisms to improve outcomes in KOA, but such programs are not currently available.

Objective

This mixed methods study aims to adapt a mind-body activity program for the unique needs of patients with KOA, depression, and obesity (GetActive-OA) delivered via live video.

Methods

Participants were adults (aged ≥45 years) from rural Kentucky with obesity (BMI≥30 kg/m²), idiopathic KOA with mild to moderate radiographic changes, and elevated depressive symptoms (9-item Patient Health Questionnaire ≥10) recruited from 2 orthopedic centers. In phase 1, we developed GetActive-OA and the study protocol using qualitative focus group feedback from the study population (N=9; 2 focus groups, 90 minutes) and multidisciplinary expertise from clinical psychologists and orthopedic researchers. In phase 2, we explored the initial feasibility, credibility, and acceptability of GetActive-OA, live video delivery, and study procedures via an open pilot with exit interviews (N=5; 1 group). This research was guided by National Institutes of Health (NIH) model stage IA.

Results

Phase 1 qualitative analyses revealed nuanced information about challenges with coping and increasing activity, high interest in a mind-body activity program, program participation facilitators (flexibility with technology) and barriers (amotivation and forgetfulness), and perceived challenges with data collection procedures (blood and urine samples and homework). Phase 2 quantitative analyses showed that GetActive-OA met most a priori feasibility markers: acceptability (80%), expectancy (100%), credibility (100%), clinician adherence (90%), homework adherence (80%), questionnaire data collection (100%), program satisfaction (100%), and safety (100%). Adherence to ActiGraph wear (80% baseline, 20% posttest) and collection of blood samples (60%) were low. Participation in GetActive-OA was associated with signals of improvements in general coping (Cohen d=2.41), pain catastrophizing (Cohen d=1.24), depression (Cohen d=0.88), anxiety (Cohen d=0.78), self-efficacy (Cohen d=0.73), pain (Cohen d=0.39), and KOA symptoms (Cohen d=0.36). Qualitative exit interviews confirmed quantitative findings and provided valuable information to optimize the program and protocol.

Conclusions

Patients with KOA, depression, and obesity from rural Kentucky were interested in a live video mind-body activity program. GetActive-OA shows promise; however, the program and protocol require further NIH stage I refinement before formal efficacy testing (NIH model stage II).

International registered report identifier (irrid)

RR2-10.1016/j.conctc.2021.100720.

SUBMITTER: Mace RA

PROVIDER: S-EPMC9096632 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

Live Video Mind-Body Program for Patients With Knee Osteoarthritis, Comorbid Depression, and Obesity: Development and Feasibility Pilot Study.

Mace Ryan A RA Greenberg Jonathan J Lemaster Nicole N Duarte Brooke B Penn Terence T Kanaya Millan M Doorley James D JD Burris Jessica L JL Jacobs Cale A CA Vranceanu Ana-Maria AM

JMIR formative research 20220427 4

<h4>Background</h4>Knee osteoarthritis (KOA) is the most common joint disorder in the United States and a leading cause of disability. Depression and obesity are highly comorbid with KOA and accelerate knee degeneration and disability through biopsychosocial mechanisms. Mind-body physical activity programs can engage biological, mechanical, and psychological mechanisms to improve outcomes in KOA, but such programs are not currently available.<h4>Objective</h4>This mixed methods study aims to ada ...[more]

PMID: 35475787

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Project description:BackgroundChronic 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.ObjectiveWe 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.MethodsThis 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).ResultsThe 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).ConclusionsPreliminary 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 digital platforms for virtual assessments and intervention delivery will inform treatment development for older adults and those with comorbid CP and CD, which is crucial during the COVID-19 pandemic.Trial registrationClinicalTrials.gov NCT04044183; https://clinicaltrials.gov/ct2/show/NCT04044183.International registered report identifier (irrid)DERR1-10.2196/25351.

Dataset Information

Live Video Mind-Body Program for Patients With Knee Osteoarthritis, Comorbid Depression, and Obesity: Development and Feasibility Pilot Study.

Background

Objective

Methods

Results

Conclusions

International registered report identifier (irrid)

Publications

Live Video Mind-Body Program for Patients With Knee Osteoarthritis, Comorbid Depression, and Obesity: Development and Feasibility Pilot Study.

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