Improving Health for Older Adults With Pain Through Engagement

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06119698
Status
Recruiting
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Conditions

  • Chronic Pain
  • Musculoskeletal Pain

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GetActive+ — BEHAVIORAL
    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.

Study Details

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/).

Key Dates

Start date
Oct 1, 2024
Status verified
Nov 2025
Primary completion
Apr 1, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Physical function - self-report [ Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) - Measure time point of 10 weeks is considered for primary outcome. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Ana-Maria Vranceanu, PhD
[email protected]
617-724-4977
Christine Ritchie, MD, MPH
[email protected]
617-726-1382

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