Improving Health for Older Adults With Pain Through Engagement (iHOPE)

November 1, 2023 updated by: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 (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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Older Adults (i.e., age >=55)
  2. Diagnosed musculoskeletal chronic pain of any type (e.g., pain > 3 months)
  3. Pain score >=4 (moderate) on the Numerical Rating Scale
  4. Cognitively able to participate as measured by the Short Portable Mental Health questionnaires (e.g., <4 errors)
  5. No self-reported current active, untreated psychotic or substance use disorder that would interfere with participation in the research study
  6. Ability to complete the 6-minute walk test under supervision of study staff
  7. Patient at Revere HealthCare Center who is cleared for participation by medical staff
  8. English fluency or Spanish fluency

Exclusion Criteria:

  1. Current serious medical illness that is expected to worsen in the next 6 months (e.g., cancer)
  2. Individuals who are unwilling or unable to wear the ActiGraph device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GetActive+
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
Behavioral: GetActive+
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.
No Intervention: Treatment as usual
Treatment as Usual (TAU) includes traditional primary care management of chronic pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical function self-report
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
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
Time Frame: 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.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Physical function - objective
Time Frame: 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.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Pain Intensity
Time Frame: 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.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Depression
Time Frame: 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.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Anxiety
Time Frame: 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.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Pain Catastrophizing
Time Frame: 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.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Pain Intensity and Interference
Time Frame: 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.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Mindfulness
Time Frame: 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.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Acceptability of Intervention Sessions
Time Frame: Post-Intervention
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
Time Frame: 120 weeks
>=75% of GetActive+ session components delivered as intended; 20% sessions rated
120 weeks
Adoption of Intervention
Time Frame: 120 weeks
Uptake, intent to implement GetActive+ by organization, clinicians, Qualitative assessment by staff and clinicians; intention to adopt.
120 weeks
Feasibility of Intervention Recruitment
Time Frame: 120 weeks
>= 75% of patients agree to participate in intervention; qualitative feedback
120 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loneliness
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
UCLA-3 Loneliness Scale; measures loneliness in relational connectedness, social connectedness, and self- perceived isolation dimensions. Scores range from 3 to 6 with higher scores indicating greater social isolation.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Social Support
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
The Interpersonal Support Evaluation List (ISEL-12), measuring perceptions of social support. This measure consists of 12 items and scores range from 12 to 48, with higher scores indicating stronger social support.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Mindfulness (2)
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Cognitive and Affective Mindfulness Scale - Revised (CAMS-R); measures mindfulness and the degree to which respondents' experience thoughts and feelings. Scores range from 12 to 48, with higher scores representing increased levels of mindfulness.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Stress
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Perceived Stress Scale (PSS-4); assesses stress perception levels. Total scores for this scale range from 0 to 16, with higher scores being correlated with more severe stress.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Post Traumatic Stress Disorder
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
The Post-Traumatic Checklist - 6 (PCL-C); assess current Post Traumatic Stress Disorder symptoms. Scores range from 6 to 30, with higher scores being suggestive of greater difficulties with post-traumatic stress.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Emotional Function
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Contrast Avoidance Questionnaire - Shortened (CAQ-S); a measure of sustaining negative emotionality to protect against sudden shifts in motion. Scores range from 8 to 40 with higher scores indicating worse outcomes.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Impression of Change
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Patient Global Impression of Change (PGIC); measures fluctuations in pain. Scores range from 0 to 24, with higher scores indicating worse outcomes.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Fear of Pain
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Tampa Kinesiophobia Scale (TSK); assesses fear of pain and activities that cause pain. Scores range from 11 to 44, with greater scores reflecting more severe kinesiophobia.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Self-Compassion
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Self-Compassion Scale - Short Form (SCS-SF); assesses participants' capacity for self-compassion. Scores are calculated by averaging the responses to the 12-item measure and range from 1 to 5. Higher scores are associated with lower levels of self-compassion.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Gratitude
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
The Gratitude Questionnaire (GQ-6) assesses individual differences in the proneness to experience gratitude in daily life. Scores range from 6 to 42 with higher score indicating greater amount of gratitude.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Substance Use
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Tobacco, Alcohol, Prescription medications, and other Substance (TAPS)44; assess substance use behaviors. Each substance is scored individually and total scores for this measure range from 0 to 20, with lower scores indicating more problematic substance use behaviors.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Current Status
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Measure of Current Status (MOCS); assesses current self-perceived status on the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Total scores on the MOCS range from 0 to 52, with higher scores reflecting a stronger ability to recognize and cope with stress.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Discrimination
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
The Everyday Discrimination Scale - Short (EDS-S); assesses experiences of daily discrimination against minority populations. Total scores for this scale range from 10 to 60, with higher scores indicating greater frequency of discriminatory experiences.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Sleep Disturbance
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
PROMIS Sleep Disturbance - Short Form 6a v1.0; assesses duration and quality of sleep. Scores range from 6 to 30, with greater scores indicating higher sleep quality and more sleep disturbance.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
Sleep Quality
Time Frame: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)
The Pittsburgh Sleep Quality Index (PSQI); assesses sleep quality. Using single item from this scale to assess sleep duration. Scores for the PSQI range from 0 to 24 with higher scores indicating more hours of sleep.
Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
  • Principal Investigator: Christine Ritchie, MD, MPH, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P001691

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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