NCT06119698 Improving Health for Older Adults With Pain Through Engagement
| NCT ID | NCT06119698 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-10-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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. Current serious medical illness that is expected to worsen in the next 6 months (e.g., cancer) 2. Individuals who are unwilling or unable to comply with study procedures including wearing a smartwatch 3. Active suicidal ideation with plan or intent 4. Active and untreated serious mental health or substance use disorder
Contact & Investigator
Ana-Maria Vranceanu, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06119698 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06119698 currently recruiting?
Yes, NCT06119698 is actively recruiting participants. Contact the research team at avranceanu@mgh.harvard.edu for enrollment information.
Where is the NCT06119698 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06119698 clinical trial?
NCT06119698 is sponsored by Massachusetts General Hospital. The principal investigator is Ana-Maria Vranceanu, PhD at Massachusetts General Hospital. The trial plans to enroll 200 participants.
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