Improving Health for Older Adults with Pain Through Engagement
- Conditions
- Chronic PainMusculoskeletal Pain
- Interventions
- Behavioral: GetActive+
- Registration Number
- NCT06119698
- Lead Sponsor
- Massachusetts General Hospital
- 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/).
- Detailed 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 organization levels based on Proctor's implementation framework using mixed methods.
The investigators will enroll N=200 older adults with chronic pain from Revere HealthCare Center and MGH Broadway Primary Care in Revere
The GetActive + program used in the Randomized Controlled Trial (RCT) will incorporate mind-body skills, cognitive behavioral and physical restoration skills (e.g., quota-based pacing) to help individuals increase self-reported, performance based and objective (step count) physical function. This program will teach participants four core skills: 1) weekly goal setting for gradual increase in time spent walking paired with activities of daily living that are meaningful and important to participants (i.e. walk instead of drive to the store; walk to the park with kids) 2) quota-based pacing (increasing walking goal gradually non-contingent of pain); 3) mind-body skills (e.g., diaphragmatic breathing to manage intense pain flares and pain anxiety; progressive muscle relaxation to increase body awareness and reduce reactivity to pain sensations; mindfulness exercises to understand the transience of pain and change one's relationship with it; self-compassion when falling short of set goals); and 4) understand the downward spiral (e.g. how reducing activity perpetuates pain and disability), correct myths about pain or automatic pain-related thoughts that interfere with meeting program goals. Participants will be encouraged to complete their homework (logs for mind-body practice, physical activities) each day. Participants will be given the option to receive homework and session reminders via text messages from study staff. This between session contact will focus on increasing treatment adherence, maintaining engagement, and session reminders. The investigators will run groups primarily in English with additional groups in Spanish.
Baseline assessments, post-intervention assessments and 6-month follow up assessments will include the 6MWT, objective step count via ActiGraph, and self-reported measures including physical function, emotional function, pain, social support, and loneliness, while accounting for clinical, demographic, and social determinants of health.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- Current serious medical illness that is expected to worsen in the next 6 months (e.g., cancer)
- Individuals who are unwilling or unable to wear the ActiGraph device
- Active suicidality
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GetActive+ GetActive+ A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
- Primary Outcome Measures
Name Time Method Physical function - self-report Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) - Measure time point of 10 weeks is considered for primary outcome. Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form 6b, Language specific adaptations exist in English, Spanish, Chinese, and Portuguese. Scores range from 8 to 40, with higher scores indicating greater physical function.
- Secondary Outcome Measures
Name Time Method Adoption of Intervention 120 weeks Uptake, intent to implement GetActive+ by organization, clinicians, Qualitative assessment by staff and clinicians; intention to adopt.
Physical function - performance-based Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) 6-minute walk test (6MWT). The 6MWT measures the total distance covered by an individual in 6 minutes, with greater distances covered indicating better physical function.
Physical function - objective Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) Average step count with ActiGraph GT3X-BTLE which measures average step count over the course of a 5-7-day period.
Pain Intensity Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) Short Form Brief Pain Inventory (BPI) pain severity; assesses pain at several time points (at its worst, least, average, and current). Scores range from 0 to 10, with higher scores indicating more severe pain severity or interference.
Depression Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) Patient Health Questionnaire (PHQ); first step approach in depression screening. Scores range from 0 to 24, with higher scores indicating more severe depressive symptoms.
Anxiety Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) Generalized Anxiety Disorder scale-7 (GAD-7); first step approach in anxiety screening. Scores range from 0 to 21, with higher scores indicating greater anxiety.
Pain Catastrophizing Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) Pain Catastrophizing Scale (PCS); assesses magnification, helplessness, and rumination about pain. Scores range from 0 to 52, with higher scores indicating increased pain catastrophizing.
Pain Intensity and Interference Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) The Pain, Enjoyment of Life and General Activity scale (PEG); brief measure of participant's self-reported pain intensity and pain interference. Scores range from 0 to 30, with higher scores indicating more severe pain and related interference.
Mindfulness Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) Applied Mindfulness Process Scale (AMPS); assesses how participants' use mindfulness when facing challenges in daily life. Scores range from 0 to 60, with higher scores indicating greater utilization of mindfulness.
Acceptability of Intervention Sessions Post-Intervention Satisfaction with or tolerability of the proposed approach. \>=75% of enrolled participants complete at least 8/10 sessions; qualitative feedback
Fidelity of Session Delivery 120 weeks \>=75% of GetActive+ session components delivered as intended; 20% sessions rated
Feasibility of Intervention Recruitment 120 weeks \>= 75% of patients agree to participate in intervention; qualitative feedback
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States