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A New Model to Reach Vulnerable Older Adults With Pain Self-management Support

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ClinicalTrials.gov Identifier: NCT04095650
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Mary Janevic, University of Michigan

Brief Summary:
Learning chronic pain self-management skills can help patients improve daily functioning and quality of life, while avoiding risks associated with opioids and other pharmacological treatments. Community health workers (CHWs) may help make chronic pain self-management interventions more accessible to older adults living in underserved communities. The goal of this study is to conduct a feasibility test of a chronic pain self-management intervention delivered by CHWs, in conjunction with mobile health tools, in a sample of 10 older adults recruited from community sites in Detroit, Michigan. This study will involve the use of mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and change in pain-related outcomes.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: STEPS (Seniors using Technology to Engage in Pain Self-management) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A New Model to Reach Vulnerable Older Adults With Pain Self-management Support
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Intervention
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.




Primary Outcome Measures :
  1. 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)..

  2. Participant engagement [ Time Frame: 8 weeks ]
    Number of completed sessions with the community health worker (range 1 to 7).


Secondary Outcome Measures :
  1. 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)).

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-proficient
  • Age >= 60 years
  • Ambulatory with or without assistive device
  • Community-living
  • Have a cell or landline phone
  • Have Internet access (home or elsewhere)
  • 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
  • Ability to attend a one-time study orientation session

Exclusion Criteria:

  • Serious acute illness or hospitalization in last month
  • Planned surgery in next three months
  • Significant cognitive impairment as indicated by affirmative response to question: "Do you have significant difficulties with your memory that get in the way of your usual daily activities?"
  • Other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit.

Information from the National Library of Medicine

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


Contacts
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Contact: Cainnear Hogan, MSW MPH 734 763 6412 cakingry@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Mary Janevic, PhD         
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Mary Janevic, PhD University of Michigan School of Public Health

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Responsible Party: Mary Janevic, Assistant Research Scientist, University of Michigan
ClinicalTrials.gov Identifier: NCT04095650     History of Changes
Other Study ID Numbers: HUM00154949
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms