Disabled PersonsOP-ENS-CLNCT06941233
Our Peers - Empowerment and Navigational Support - Community Living (OP-ENS-CL): A Peer Navigator Intervention for Adults With Acquired Physical Disabilities
A study testing Our Peers - Empowerment and Navigational Support - Community Living (OP-ENS - CL) in people with Disabled Persons, run by Susan Magasi at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disabled Persons
- What is being tested?
- Our Peers - Empowerment and Navigational Support - Community Living (OP-ENS - CL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: 1) Self-identify as a person with physical disability due to a neurological condition, including SCI, stroke, TBI, multiple sclerosis, or Parkinson's disease (according to the American Community Survey 6-Items), 2) onset of disability within the last 6 months, 3) transitioned to community living in the past 4 months, 4) able to speak, read and understand English, 5) own or have regular access to either a smartphone (Android or iOS operating system), tablet, laptop, or desktop computer with internet access. 6) adults 18 years of age or older, 7) able to provide informed consent.
Exclusion Criteria: 1) Cognitive, sensory, or physical functional limitations that interfere with effective use of the OP-ENS - CL app.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Shirley Ryan Ability Lab
Chicago, Illinois, 60612
Elliot Roth, MD, 312-238-1657, eroth@sral.org
Sarah Zera, OTD, OTR/L, 312-210-0523, szera2@uic.edu
- Not yet recruiting
University of Illinois Chicago, Department of Occupational Therapy
Chicago, Illinois, 60612
Susan Magasi, PhD, 312-996-4603, smagas1@uic.edu
Susan Magasi, PhD
About this study
Official title: Our Peers - Empowerment and Navigational Support - Community Living (OP-ENS - CL)
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?
Read more
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?
Read the detailed description
The purpose of this study is to evaluate the efficacy and social validity of the OP-ENS - CL (Our Peers - Empowerment and Navigational Support - Community Living) a remote 12-month peer navigator intervention using a clinical trial design in a sample of adults with newly acquired with physical disabilities transitioning to community living.
Participants will be recruited through community and clinical networks and screened for eligibility. Participants will be randomly assigned to either the intervention or usual care groups. Participants in the intervention group will be matched with a trained peer health navigator (who is also a person with a physical disability). Using a structure process of barrier identification, goal setting and action planning peer health navigators will work with participants to help address their healthcare needs and concerns, including such things as patient-provider communication, transportation, access to durable medical equipment. It is important to note that peer health navigators are not healthcare providers and do not provide medical or health advice. Participants in the intervention trial are asked to meet with their peer navigator at least once a month during the study period. To encourage participation in this intervention, progressive micro-incentives are integrated into the study protocol. To promote equipoise, a similar micro-incentive schedule is created for the usual care group.
Data Collection - All participants, regardless of group assignment, will be interviewed at 3 time points (baseline, 6 months, 13 months) using a self-report measures of healthcare access, quality, and outcomes as well as measures of social support and patient activation. Data collectors will be blinded to group assignment and not involved in the delivery of the OP-ENS - CL intervention.
Data Analysis - The investigators will employ mixed effects model using each study outcome as a time-varying dependent variable and treatment group (PHN vs. usual care) as the main fixed effect. Baseline characteristics including race/ethnicity, gender, and socioeconomic status will be entered as time-invariant covariates if baseline group differences are observed (in spite of randomization). Subject intercept will be modeled as a random effect. The null hypothesis will be rejected if a significant group*time interaction effect is observed. The investigators hypothesize that PN will have a more favorable trajectory slope of study outcomes than the matched control group. For each hypothesis, post-hoc analysis will be conducted to assess difference in each outcome variable between the two groups at different time points. The mixed models will run using PROC MIXED from of SAS 9.3 (Cary, NC). The method of estimation will be maximum likelihood (ML). A variety of covariance structures (first order regressive, compound symmetry, toeplitz, variance components, unstructured) will be carefully examined and compared for best model fit, Akaike's Information (AIC) and Bayesian Information Criteria (BIC). These statistics are functions of the log likelihood and can be compared across models. As missing data are inevitable in a longitudinal study, values will be imputed where possible using either mean (median) substitute or formal imputation procedures such as EM algorithm if missing data are MCAR (missing completely at random) or MAR (missing at random). If missing data are NMAR (not missing at random), the "pattern mixture" approach will be used to compute a "weighted average" of the parameters that are associated with the missing data to estimate what the data would have been.
- Conditions
- Disabled Persons
- Being tested
- Our Peers - Empowerment and Navigational Support - Community Living (OP-ENS - CL)
- Keywords
- peer navigators, community health worker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Our Peers - Empowerment and Navigational Support - Community Living (OP-ENS - CL)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation Measure
The 13-item self-report measure assesses perceived knowledge, skills, and confidence for self-management
Measured: 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
Measured: 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
Measured: Baseline, 6 months, 13 months.
PROMIS informational support, short form
8-item self-report short forms assessing the availability of informational support
Measured: Baseline, 6 months, 13 months.
PROMIS Instrumental Support, short form
8-item self-report short forms assessing the availability of instrumental support
Measured: Baseline, 6 months, 13 months.
Secondary outcomes (5)
PROMIS Global Health
8-item self-report short form assessing perceived physical, mental, and social health.
Measured: Baseline, 6 months, 13 months.
PROMIS Depression
8-item short form assessing self-reported affect, views of self, social cognition, and decreased positive affect
Measured: Baseline, 6 months, 13 months.
PROMIS Ability to Participate in Social Roles and Activities
8-item short form assessing perceived ability to perform one's usual social roles and activities
Measured: Baseline, 6 months, 13 months.
Community Participation Indicators, Enfranchisement Scale
19-item self-report measures 3 subjective domains of participation, choice and control, contributing to one's community, and feeling valued.
Measured: Baseline, 6 months, 13 months.
Canadian Occupational Performance Measure
Semi-structured interview including 5 step process to identify subjects' goals. Subjects rate their perceived performance and satisfaction on 1 - 5 goals.
Measured: Baseline, 6 months, 13 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Dec 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disabled PersonsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Susan Magasi
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Shirley Ryan AbilityLab
- Responsible party
- Sponsor-investigator, Susan Magasi, University of Illinois Chicago
- Investigators
- Susan Magasi, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941233
- Sponsor's protocol ID
- 2025-0397
- Other IDs
- 90RTCP0005-01-00
- Acronym
- OP-ENS-CL
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To preserve the privacy and confidentiality of study participants, we may elect not to share the IPD.
Publications
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.
PubMed 34497460Magasi 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.
PubMed 34780614
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Our Peers - Empowerment and Navigational Support - Community Living (OP-ENS - CL)
- ClinicalTrials.gov ID
- NCT06941233
- Acronym / sponsor ID
- OP-ENS-CL / 2025-0397
- Conditions
- Disabled Persons
- Keywords
- peer navigators, community health worker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Susan MagasiUniversity, hospital or other
- Collaborators
- Northwestern University, Shirley Ryan AbilityLab
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
The purpose of this study is to evaluate the efficacy and social validity of the OP-ENS - CL (Our Peers - Empowerment and Navigational Support - Community Living) a remote 12-month peer navigator intervention using a clinical trial design in a sample of adults with newly acquired with physical disabilities transitioning to community living.
Participants will be recruited through community and clinical networks and screened for eligibility. Participants will be randomly assigned to either the intervention or usual care groups. Participants in the intervention group will be matched with a trained peer health navigator (who is also a person with a physical disability). Using a structure process of barrier identification, goal setting and action planning peer health navigators will work with participants to help address their healthcare needs and concerns, including such things as patient-provider communication, transportation, access to durable medical equipment. It is important to note that peer health navigators are not healthcare providers and do not provide medical or health advice. Participants in the intervention trial are asked to meet with their peer navigator at least once a month during the study period. To encourage participation in this intervention, progressive micro-incentives are integrated into the study protocol. To promote equipoise, a similar micro-incentive schedule is created for the usual care group.
Data Collection - All participants, regardless of group assignment, will be interviewed at 3 time points (baseline, 6 months, 13 months) using a self-report measures of healthcare access, quality, and outcomes as well as measures of social support and patient activation. Data collectors will be blinded to group assignment and not involved in the delivery of the OP-ENS - CL intervention.
Data Analysis - The investigators will employ mixed effects model using each study outcome as a time-varying dependent variable and treatment group (PHN vs. usual care) as the main fixed effect. Baseline characteristics including race/ethnicity, gender, and socioeconomic status will be entered as time-invariant covariates if baseline group differences are observed (in spite of randomization). Subject intercept will be modeled as a random effect. The null hypothesis will be rejected if a significant group*time interaction effect is observed. The investigators hypothesize that PN will have a more favorable trajectory slope of study outcomes than the matched control group. For each hypothesis, post-hoc analysis will be conducted to assess difference in each outcome variable between the two groups at different time points. The mixed models will run using PROC MIXED from of SAS 9.3 (Cary, NC). The method of estimation will be maximum likelihood (ML). A variety of covariance structures (first order regressive, compound symmetry, toeplitz, variance components, unstructured) will be carefully examined and compared for best model fit, Akaike's Information (AIC) and Bayesian Information Criteria (BIC). These statistics are functions of the log likelihood and can be compared across models. As missing data are inevitable in a longitudinal study, values will be imputed where possible using either mean (median) substitute or formal imputation procedures such as EM algorithm if missing data are MCAR (missing completely at random) or MAR (missing at random). If missing data are NMAR (not missing at random), the "pattern mixture" approach will be used to compute a "weighted average" of the parameters that are associated with the missing data to estimate what the data would have been.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| OP-ENS - CL Intervention | Experimental | Behavioral: Our Peers - Empowerment and Navigational Support - Community Living (OP-ENS - CL)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Our Peers - Empowerment and Navigational Support - Community Living (OP-ENS - CL)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. | Behavioural | OP-ENS - CL Intervention |
Primary outcome
Patient Activation Measure
Time frame: Baseline, 6 months, 13 months.
The 13-item self-report measure assesses perceived knowledge, skills, and confidence for self-management
PROMIS Self-Efficacy Short Form
Time frame: Baseline, 6 months, 13 months.
4-item self-report short form measure assessing confidence in one's ability to perform specific tasks or behaviors
PROMIS Emotional Support, short form
Time frame: Baseline, 6 months, 13 months.
8-item self-report short forms assessing the availability of 3 types of emotional support
PROMIS informational support, short form
Time frame: Baseline, 6 months, 13 months.
8-item self-report short forms assessing the availability of informational support
PROMIS Instrumental Support, short form
Time frame: Baseline, 6 months, 13 months.
8-item self-report short forms assessing the availability of instrumental support
5 secondary outcomes
PROMIS Global Health
Time frame: Baseline, 6 months, 13 months.
PROMIS Depression
Time frame: Baseline, 6 months, 13 months.
PROMIS Ability to Participate in Social Roles and Activities
Time frame: Baseline, 6 months, 13 months.
Community Participation Indicators, Enfranchisement Scale
Time frame: Baseline, 6 months, 13 months.
Canadian Occupational Performance Measure
Time frame: Baseline, 6 months, 13 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 34497460Magasi 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.
- Background: PubMed 34780614Magasi 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.
- The Program for Healthcare Justice for People with Disabilities is the principal investigator, Susan Magasi, lab website.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. To preserve the privacy and confidentiality of study participants, we may elect not to share the IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Magasi, PhD principal investigator
University of Illinois Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Our Peers - Empowerment and Navigational Support - Community Living (OP-ENS - CL) in people with Disabled Persons, run by Susan Magasi at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Magasi, PhD (312-996-4603, smagas1@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation Measure (time frame: Baseline, 6 months, 13 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06941233, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.