NCT06941233

Brief Summary

The goal of this clinical trial is to learn if a remote peer navigator intervention (OP-ENS - CL) for people with newly acquired physical disabilities returning to community living after rehabilitation improves self-reported social support, health, and community participation. The main questions it aims to answer are: Do people with acquired physical disabilities who receive the remote peer navigator intervention experience greater social support and self-efficacy than people in the control group? Do people with acquired physical disabilities who receive the remote peer navigator intervention have better self-reported health and social participation outcomes than people in the control group? Is the OP-ENS - CL intervention acceptable to people with newly acquired physical disabilities returning to community living?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Jun 2025Aug 2027

First Submitted

Initial submission to the registry

April 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 23, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

April 15, 2025

Last Update Submit

April 15, 2025

Conditions

Keywords

peer navigatorscommunity health worker

Outcome Measures

Primary Outcomes (5)

  • Patient Activation Measure

    The 13-item self-report measure assesses perceived knowledge, skills, and confidence for self-management

    Baseline, 6 months, 13 months.

  • PROMIS Self-Efficacy Short Form

    4-item self-report short form measure assessing confidence in one's ability to perform specific tasks or behaviors

    Baseline, 6 months, 13 months.

  • PROMIS Emotional Support, short form

    8-item self-report short forms assessing the availability of 3 types of emotional support

    Baseline, 6 months, 13 months.

  • PROMIS informational support, short form

    8-item self-report short forms assessing the availability of informational support

    Baseline, 6 months, 13 months.

  • PROMIS Instrumental Support, short form

    8-item self-report short forms assessing the availability of instrumental support

    Baseline, 6 months, 13 months.

Secondary Outcomes (5)

  • PROMIS Global Health

    Baseline, 6 months, 13 months.

  • PROMIS Depression

    Baseline, 6 months, 13 months.

  • PROMIS Ability to Participate in Social Roles and Activities

    Baseline, 6 months, 13 months.

  • Community Participation Indicators, Enfranchisement Scale

    Baseline, 6 months, 13 months.

  • Canadian Occupational Performance Measure

    Baseline, 6 months, 13 months.

Other Outcomes (1)

  • Patient Satisfaction with Logistical Aspects of Navigation Scale

    13-month

Study Arms (2)

OP-ENS - CL Intervention

EXPERIMENTAL

Participants will be matched with a peer navigator. As part of this complex behavioral intervention, participants and peer navigators will engage in a systematic process of barrier and strength identification, goal setting and action planning related to issues of healthcare access and quality. Participants and peers will meet remotely at least monthly over the course of the 12-month study period (but frequency is determined by participant need). Given the nature of the disability and community living experience, we anticipate the needs and therefore frequency will fluctuate over the duration of the study period. Beginning in month 10, participants and peers will engage in a period of transition planning to ensure that participants have the strategies and supports in place to assume the role of their own navigator.

Behavioral: Our Peers - Empowerment and Navigational Support - Community Living (OP-ENS - CL)

Usual Care

NO INTERVENTION

Participants randomized to the usual care group will continue with their usual health, healthcare, and community living services routines. Participants in the usual care group will receive a monthly newsletter with general interest information relevant to the disability community.

Interventions

Op-ENS - CL is a 12-month, remote delivered peer navigator intervention. Participants will meet with a trained peer navigator who mentors nad supports them through a manualized process of collaborative conversations, barrier identification, asset mapping, goal setting, and action planning along with on-going social support and information sharing.

OP-ENS - CL Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Chicago, Department of Occupational Therapy

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

  • Magasi S, Papadimitriou C, Panko Reis J, The K, Thomas J, VanPuymbrouck L, Wilson T. Our Peers-Empowerment and Navigational Support (OP-ENS): Development of a Peer Health Navigator Intervention to Support Medicaid Beneficiaries With Physical Disabilities. Rehabil Process Outcome. 2019 Apr 26;8:1179572719844759. doi: 10.1177/1179572719844759. eCollection 2019.

    PMID: 34497460BACKGROUND
  • Magasi S, Angell AM, Papadimitriou C, Ramirez RD, Ferlin A, Reis JP, Wilson T. Inside an Occupational Therapy-Disability Community Partnership to Promote Health Management: Ethnography of a Research Collaboration. Am J Occup Ther. 2021 Jul 1;75(4):7504180050p1-7504180050p12. doi: 10.5014/ajot.2021.045468.

    PMID: 34780614BACKGROUND

Related Links

Study Officials

  • Susan Magasi, PhD

    University of Illinois Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Magasi, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Given the nature of the intervention it is not possible to mask participants and interventionists to group assignment. Outcome assessor and investigators will be unaware of group assignment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the intervention or usual care groups using block randomization with randomly selected blocks of 4, 8, or 12. Randomization sequence will be generated using SAS algorithm.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2025

First Posted

April 23, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 23, 2025

Record last verified: 2025-04

Locations