Randomized, Hybrid Type 1 Effectiveness-implementation Trial of GetActive+ vs Treatment as Usual; iHOPE Study
Massachusetts General Hospital
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/).
Description
The aim of this phase is to conduct a randomized, hybrid type 1 effectiveness-implementation trial (N=200) to evaluate the effectiveness and implementation of GetActive+ vs TAU on the following outcomes. Aim 1: Self-reported physical function at 10 weeks (primary). Aim 2: Self-reported physical function at 6 months, performance based (6-minute walk test), and objective (step-count) physical function, as well as self-reported emotional function, pain, social support and loneliness at 10 weeks and 6 months. Aim 3: Feasibility, acceptability, fidelity and adoption at patient, provider, and orga…
Eligibility
- Age range
- 55+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Older Adults (i.e., age \>=55) 2. Diagnosed musculoskeletal chronic pain of any type (e.g., pain \> 3 months) 3. Pain score \>=4 (moderate) on the Numerical Rating Scale 4. Cognitively able to participate as measured by the Short Portable Mental Health questionnaires (e.g., \<4 errors) 5. Self-reported ability to complete the 6-minute walk test including with assistive devices 6. Patient at Revere HealthCare Center or MGH Broadway Primary Care in Revere who is cleared for participation by medical staff 7. English or Spanish fluency and literacy Exclusion Criteria: 1.…
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.
Location
- Massachusetts General HospitalBoston, Massachusetts