Improving Health for Older Adults With Pain Through Engagement — iHOPE  

Chronic Pain Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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, post-intervention and 6-month follow-up.

Clinical Trial 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 (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. ;

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

• NCT number: NCT06119698
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Ana-Maria Vranceanu, PhD
• Phone: 617-724-4977
• Email: avranceanu@mgh.harvard.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Completion date: July 1, 2027