A New Model to Reach Vulnerable Older Adults With Pain Self-management Support
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|ClinicalTrials.gov Identifier: NCT04095650|
Recruitment Status : Completed
First Posted : September 19, 2019
Last Update Posted : January 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: STEPS (Seniors using Technology to Engage in Pain Self-management)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A New Model to Reach Vulnerable Older Adults With Pain Self-management Support|
|Actual Study Start Date :||September 20, 2019|
|Actual Primary Completion Date :||May 14, 2020|
|Actual Study Completion Date :||May 14, 2020|
Participants will engage in a 7-week chronic pain self-management program.
Behavioral: STEPS (Seniors using Technology to Engage in Pain Self-management)
Participants will meet with a community health worker (CHW) at a one-hour in-person study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and associated materials, and schedule six weekly telephone sessions with the CHW. Participants will be given a wearable physical activity tracker to use throughout the course of the program. They can choose to report daily step counts by automatically syncing to an app or via text message. Each week during the study period, participants will engage with content on the website, have a session with the community health worker, track their daily steps, and set and work toward pain-management goals.
- Change in pain interference [ Time Frame: baseline and 8 weeks ]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)..
- Participant engagement [ Time Frame: 8 weeks ]Number of completed sessions with the community health worker (range 1 to 7).
- Participant Global Impression of Change [ Time Frame: 8 weeks ]Two items: 1) How participant thinks their pain has changed from baseline (much worse (-3) to much better(+3)). 2) How participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)).
- Participant satisfaction: Likert-scale questions [ Time Frame: 8 weeks ]Likert-scale questions about participant satisfaction with the program; e.g., whether participation increased understanding of pain management (Strongly Agree=1 to Strongly Disagree=5), and with selected program elements (e.g., community health workers, videos, website).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095650
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Mary Janevic, PhD||University of Michigan School of Public Health|