Improving Health for Older Adults With Pain Through Engagement (Open-pilot)

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to conduct an open-pilot (N=30) to evaluate the feasibility, acceptability, and fidelity of a mind-body and activity program (GetActive+) with older adults with chronic pain. 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 and post-intervention.

Detailed Description
-----------------
The aim of this phase is to establish feasibility (primary), acceptability, and fidelity of GetActive+ and study procedures in an open pilot (N=30). Deliverables: GetActive+ will be feasible (≥75% agree to participate), acceptable (≥75% of those enrolled will complete 8/10 sessions) and delivered with fidelity (≥75% sessions delivered as intended). Our patients will be older adults with chronic pain from Revere HealthCare Center. The GetActive+ program 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 disability 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 and post-intervention assessments will include the 6MWT, objective step count via ActiGraph, and self-reported measures including physical function, emotional function, pain, social support, and loneliness.

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

Conditions
-----------------
Chronic Pain, Musculoskeletal Pain

Intervention / Treatment
-----------------
* Behavioral: GetActive+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older Adults (i.e., age >=55) Diagnosed musculoskeletal chronic pain of any type (e.g., pain > 3 months); diagnosed musculoskeletal chronic pain of any type (e.g., pain > 3-6 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 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
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 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>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of intervention completion | >=75 of patients approached agree to participate in intervention | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function, performance-based | 6-minute walk test (6MWT), assesses distance walked in 6 minutes. | Baseline (0 weeks), Post-test (1 week after intervention completion) | 
| Physical function - objective | Average step count with ActiGraph GT3X-BTLE | Baseline (0 weeks), Post-test (1 week after intervention completion) | 
| Short Form Brief Pain Inventory (BPI) pain severity and interference subscales | The Short Form Brief Pain Inventory (BPI) pain severity subscale assesses pain at its worst, least, average, and current. Minimum = 0, maximum = 10. Higher scores indicate worse outcome. The interference subscale assesses pain interference in the last 24 hours. Minimum = 0, maximum = 10. Higher scores indicate worse interference. | Baseline (0 weeks), Post-test (1 week after intervention completion) | 
| Patient Health Questionnaire-8 (PHQ-8) | The Patient Health Questionnaire (PHQ-8) is an assessment of depressive symptoms. Total summary score with Minimum = 0, Maximum = 24. Higher scores indicate worse outcome. | Baseline (0 weeks), Post-test (1 week after intervention completion) | 
| Generalized Anxiety Disorder scale-7 (GAD-7); | The Generalized Anxiety Disorder scale-7 (GAD-7) is an assessment of generalized anxiety symptoms. GAD-7 total score is obtained by adding the score for each of the items. Minimum = 0, Maximum = 21. Scores of 5-9 (mild), 10-14 (moderate), and 15-21 (severe) represent thresholds for mild, moderate, and severe anxiety. Higher scores indicate worse outcome. | Baseline (0 weeks), Post-test (1 week after intervention completion) | 
| Physical function self-report | Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form 6b, self-report ability to engage in physical activities. Total summary score with Minimum = 8, Maximum = 40. Higher scores reflect greater physical function. | Baseline (0 weeks), Post-test (1 week after intervention completion) | 
| Acceptability | Satisfaction with or tolerability of the proposed approach >=75% of enrolled participants complete at least 8/10 sessions. | 10 weeks | 
| Fidelity | >=75% of GetActive+ sessions components delivered as intended; 20% sessions rated | 10 weeks | 

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