RecruitingNot ApplicableNCT06119698

Improving Health for Older Adults With Pain Through Engagement

Randomized, Hybrid Type 1 Effectiveness-implementation Trial of GetActive+ vs Treatment as Usual; iHOPE Study

Sponsor

Massachusetts General Hospital

Enrollment

200 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Musculoskeletal Pain Chronic Pain

Summary

The goal of this project is to conduct a randomized, hybrid type 1 effectiveness-implementation trial (N=200) to evaluate the effectiveness and implementation of a 10-week mind-body and walking program (GetActive+) vs treatment as usual (TAU). The investigators will test for improvements in self-reported, performance-based (i.e., six-minute walk test), and objective (i.e., step-count) physical function, emotional function, as well as feasibility, acceptability and implementation markers. Participants will complete measures at baseline (0 weeks), post-intervention (1 week after intervention completion), and 6-month follow-up. This study will receive support from and inclusion in the HEAL Initiative (https://heal.nih.gov/).

Eligibility

Min Age: 55 Years

Inclusion Criteria7

Older Adults (i.e., age >=55)
Diagnosed musculoskeletal chronic pain of any type (e.g., pain > 3 months)
Pain score >=4 (moderate) on the Numerical Rating Scale
Cognitively able to participate as measured by the Short Portable Mental Health questionnaires (e.g., <4 errors)
Self-reported ability to complete the 6-minute walk test including with assistive devices
Patient at Revere HealthCare Center or MGH Broadway Primary Care in Revere who is cleared for participation by medical staff
English or Spanish fluency and literacy

Exclusion Criteria4

Current serious medical illness that is expected to worsen in the next 6 months (e.g., cancer)
Individuals who are unwilling or unable to comply with study procedures including wearing a smartwatch
Active suicidal ideation with plan or intent
Active and untreated serious mental health or substance use disorder

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Interventions

BEHAVIORALGetActive+

This is a 10-week group mind body program focused on improving self-reported physical activity, performance-based physical activity, and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increase in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.