Improving Health for Older Adults With Pain Through Engagement

Chronic Pain Clinical Trial

— iHOPE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06119698
• Other study ID #: 2022P001691
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Ana-Maria Vranceanu, PhD
• Phone: 617-724-4977
• Email: avranceanu[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

Greenberg J, Lin A, Popok PJ, Kulich RJ, Edwards RR, Vranceanu AM. Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain. J Clin Psychol Med Settings. 2021 Dec;28(4):706-719. doi: 10.1007/s10880-020-09758-w. Epub 2021 Jan 19. — View Citation

Grunberg VA, Greenberg J, Mace RA, Bakhshaie J, Choi KW, Vranceanu AM. Fitbit Activity, Quota-Based Pacing, and Physical and Emotional Functioning Among Adults With Chronic Pain. J Pain. 2022 Nov;23(11):1933-1944. doi: 10.1016/j.jpain.2022.07.003. Epub 2022 Jul 29. — View Citation

Popok PJ, Greenberg J, Gates MV, Vranceanu AM. A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain. Complement Ther Clin Pract. 2021 Aug;44:101410. doi: 10.1016/j.ctcp.2021.101410. Epub 2021 May 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Loneliness	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)
Other	Social Support	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)
Other	Mindfulness (2)	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)
Other	Stress	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)
Other	Post Traumatic Stress Disorder	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)
Other	Emotional Function	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)
Other	Impression of Change	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)
Other	Fear of Pain	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)
Other	Self-Compassion	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)
Other	Gratitude	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)
Other	Substance Use	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)
Other	Current Status	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)
Other	Discrimination	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)
Other	Sleep Disturbance	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)
Other	Sleep Quality	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Fidelity of Session Delivery	>=75% of GetActive+ session components delivered as intended; 20% sessions rated	120 weeks
Secondary	Adoption of Intervention	Uptake, intent to implement GetActive+ by organization, clinicians, Qualitative assessment by staff and clinicians; intention to adopt.	120 weeks
Secondary	Feasibility of Intervention Recruitment	>= 75% of patients agree to participate in intervention; qualitative feedback	120 weeks