Randomized, Hybrid Type 1 Effectiveness-implementation Trial of GetActive+ Vs Treatment As Usual; IHOPE Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• 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)

• No self-reported current active, untreated psychotic or substance use disorder that would interfere with participation in the research study

• Self-reported ability to complete the 6-minute walk test

• Patient at Revere HealthCare Center or MGH Broadway Primary Care in Revere who is cleared for participation by medical staff

• English fluency or Spanish fluency

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Ana-Maria Vranceanu, PhD
avranceanu@mgh.harvard.edu
617-724-4977
Backup
Christine Ritchie, MD, MPH
csritchie@mgh.harvard.edu,
617-726-1382
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2027-07
Participants
Target number of participants: 200
Treatments
Experimental: GetActive+
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
No_intervention: Treatment as usual
Treatment as Usual (TAU) includes traditional primary care management of chronic pain.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov