Improving Health for Older Adults With Pain Through Engagement

Study Overview
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Brief Summary
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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, post-intervention and 6-month follow-up.

Detailed Description
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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 (6-Minute Walk Test (6MWT)) and objective (step count) physical function, pain, depression and anxiety 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. 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; body scan 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 an additional group 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. The investigators will also conduct staff and patient interviews at the end of the intervention to assess feasibility, acceptability and adoption at the patient, provider, and organization levels. The investigators will integrate qualitative and quantitative data using mixed methods with an explanatory design.

Official Title
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Addressing the Epidemic of Chronic Pain Among Older Adults in Underserved Communities; The GetActive+ Study

Conditions
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Chronic Pain, Musculoskeletal Pain

Intervention / Treatment
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* Behavioral: GetActive+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Ability to complete the 6-minute walk test under supervision of study staff Patient at Revere HealthCare Center who is cleared for participation by medical staff English fluency or Spanish fluency Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GetActive+<br>A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain | Behavioral: GetActive+<br>* This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.<br>|
| No Intervention: Treatment as usual<br>Treatment as Usual (TAU) includes traditional primary care management of chronic pain. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function self-report | 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. | Baseline, Post-Intervention, 6-Month Follow Up ( 9 months total) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function, performance-based | 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. | Baseline, Post-Intervention, 6-Month Follow Up ( 9 months total) | 
| Physical function - objective | Average step count with ActiGraph GT3X-BTLE which measures average step count over the course of a 5-7-day period. | Baseline, Post-Intervention, 6-Month Follow Up ( 9 months total) | 
| Pain Intensity | 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. | Baseline, Post-Intervention, 6-Month Follow Up ( 9 months total) | 
| Depression | Patient Health Questionnaire (PHQ); first step approach in depression screening. Scores range from 0 to 24, with higher scores indicating more severe depressive symptoms. | Baseline, Post-Intervention, 6-Month Follow Up ( 9 months total) | 
| Anxiety | 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. | Baseline, Post-Intervention, 6-Month Follow Up ( 9 months total) | 
| Pain Catastrophizing | Pain Catastrophizing Scale (PCS); assesses magnification, helplessness, and rumination about pain. Scores range from 0 to 52, with higher scores indicating increased pain catastrophizing. | Baseline, Post-Intervention, 6-Month Follow Up ( 9 months total) | 
| Pain Intensity and Interference | 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. | Baseline, Post-Intervention, 6-Month Follow Up ( 9 months total) | 
| Mindfulness | 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. | Baseline, Post-Intervention, 6-Month Follow Up ( 9 months total) | 
| Acceptability of Intervention Sessions | Satisfaction with or tolerability of the proposed approach. >=75% of enrolled participants complete at least 8/10 sessions; qualitative feedback | Post-Intervention | 
| Fidelity of Session Delivery | >=75% of GetActive+ session components delivered as intended; 20% sessions rated | 120 weeks | 
| Adoption of Intervention | Uptake, intent to implement GetActive+ by organization, clinicians, Qualitative assessment by staff and clinicians; intention to adopt. | 120 weeks | 
| Feasibility of Intervention Recruitment | >= 75% of patients agree to participate in intervention; qualitative feedback | 120 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older adults, Mind-body intervention, Chronic pain, ActiGraph, Community health center, Physical function