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

Primary Purpose

Chronic Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

STEPS (Seniors using Technology to Engage in Pain Self-management)

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Participants will engage in a 7-week chronic pain self-management program.

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)..

Participant engagement

Number of completed sessions with the community health worker (range 1 to 7).

Secondary Outcome Measures

Participant Global Impression of Change

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

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).

Full Information

NCT ID

NCT04095650

First Posted

September 17, 2019

Last Updated

January 4, 2021

Sponsor

University of Michigan

Collaborators

National Institute on Aging (NIA), American Pain Society

1. Study Identification

Unique Protocol Identification Number

NCT04095650

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

September 20, 2019 (Actual)

Primary Completion Date

May 14, 2020 (Actual)

Study Completion Date

May 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Institute on Aging (NIA), American Pain Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 25 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.

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

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Participants will engage in a 7-week chronic pain self-management program.

Intervention Type

Behavioral

Intervention Name(s)

STEPS (Seniors using Technology to Engage in Pain Self-management)

Intervention Description

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 Measure Information:

Title

Change in pain interference

Description

Time Frame

baseline and 8 weeks

Title

Participant engagement

Description

Number of completed sessions with the community health worker (range 1 to 7).

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Participant Global Impression of Change

Description

Time Frame

8 weeks

Title

Participant satisfaction: Likert-scale questions

Description

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Janevic, PhD

Organizational Affiliation

University of Michigan School of Public Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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