STEPS: An Efficacy Trial of a Chronic Pain Self-Management Program for Older Adults
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEPS
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Community-living
- Have a cell or landline phone
- Self-reported chronic musculoskeletal pain (pain in muscles or joints for >= 3 months); >=4 (0-10 scale) average pain level over last week; >=1 day/previous 30 when pain made it difficult to do usual activities.
- Able to converse comfortably in English
Exclusion Criteria:
- Serious acute illness or hospitalization in last month
- Planned major surgery in next three months that would interfere with program participation (e.g., knee or hip replacement);
- Severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose significant barrier to participation
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention arm
Usual care control arm
Arm Description
Participants will engage in a 7-week multicomponent chronic pain self-management program.
After completing the 12 month telephone survey, control group participants will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a workshop that provides key intervention content and individualized goal-setting guidance.
Outcomes
Primary Outcome Measures
Change in Pain Interference
The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-43 Adult Profile. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much); raw total scale scores range from 6 (low interference) to 30 (high interference). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing worse outcome.
Secondary Outcome Measures
Participant Global Impression of Change--Pain
How participant thinks their pain has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Participant Global Impression of Change - Functioning
How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Change in pain intensity
A numeric rating scale ranging from 0 (no pain at all; best outcome) to 10 (worst pain you can imagine; worst outcome)
Full Information
NCT ID
NCT05278234
First Posted
March 3, 2022
Last Updated
December 1, 2022
Sponsor
University of Michigan
Collaborators
National Institute on Aging (NIA), Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT05278234
Brief Title
STEPS: An Efficacy Trial of a Chronic Pain Self-Management Program for Older Adults
Official Title
An Efficacy Trial of Community Health Worker-Delivered Chronic Pain Self-Management Support for Vulnerable Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Aging (NIA), Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to determine whether community health workers (CHWs)-i.e., lay health workers with close ties to the communities they serve - can effectively teach cognitive-behavioral pain management strategies to older adults in a disadvantaged urban setting. Specific aims are: to test, in a sample of 414 primarily African American older adults, whether the STEPS pain self-management intervention, delivered over 7 weeks through telephone sessions with a CHW and mobile health tools, improves pain outcomes at 2 and 12 months compared to a usual care control group. We will also assess the mechanisms by which the intervention may bring about positive changes in pain outcomes. We will use mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and factors affecting implementation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
414 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Participants will engage in a 7-week multicomponent chronic pain self-management program.
Arm Title
Usual care control arm
Arm Type
No Intervention
Arm Description
After completing the 12 month telephone survey, control group participants will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a workshop that provides key intervention content and individualized goal-setting guidance.
Intervention Type
Behavioral
Intervention Name(s)
STEPS
Other Intervention Name(s)
Seniors using Technology to Engage in Pain Self-management
Intervention Description
Participants will initially meet with a community health worker (CHW) for a 1-hour orientation at the participant's home, a Henry Ford Health System site or the University of Michigan Detroit Center, or virtual. The CHW will show participants how to use the web modules. Participants will be given (or mailed) a wearable activity tracker to use throughout the course of the 7-week program. Each week participants will watch a brief video on the STEPS website; they may also be asked to complete handouts in the workbook. They will have a weekly 30-minute telephone session with the CHW. CHWs will review the weekly topic, help participants practice new skills, and set a related goal. CHWs will screen for social needs and make appropriate community referrals. Participants will set walking goals each week, using step-count data from the physical activity tracker. Participants will track daily step counts.
Primary Outcome Measure Information:
Title
Change in Pain Interference
Description
The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-43 Adult Profile. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much); raw total scale scores range from 6 (low interference) to 30 (high interference). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing worse outcome.
Time Frame
Baseline, 2 months from baseline, and 12 months from baseline
Secondary Outcome Measure Information:
Title
Participant Global Impression of Change--Pain
Description
How participant thinks their pain has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Time Frame
2 months from baseline, and 12 months from baseline
Title
Participant Global Impression of Change - Functioning
Description
How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Time Frame
2 months from baseline, and 12 months from baseline
Title
Change in pain intensity
Description
A numeric rating scale ranging from 0 (no pain at all; best outcome) to 10 (worst pain you can imagine; worst outcome)
Time Frame
Baseline, 2 months from baseline, and 12 months from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Community-living
Have a cell or landline phone
Self-reported chronic musculoskeletal pain (pain in muscles or joints for >= 3 months); >=4 (0-10 scale) average pain level over last week; >=1 day/previous 30 when pain made it difficult to do usual activities.
Able to converse comfortably in English
Exclusion Criteria:
Serious acute illness or hospitalization in last month
Planned major surgery in next three months that would interfere with program participation (e.g., knee or hip replacement);
Severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose significant barrier to participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Janevic
Phone
7346473194
Email
mjanevic@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Lindsay
Email
reblin@umich.edu
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Janevic, PhD
12. IPD Sharing Statement
Learn more about this trial
STEPS: An Efficacy Trial of a Chronic Pain Self-Management Program for Older Adults
We'll reach out to this number within 24 hrs