SCI&U Peer Health Coaching Program for Individuals Newly Discharged From Inpatient Rehabilitation (SCIU2)

August 28, 2025 updated by: Susan Jaglal, University of Toronto

The goal of this clinical trial is to learn if the online program and web-based platform for delivery of self-management services to people with spinal cord injury (SCI) called "SCI & U" can support transitions from hospital to the community after injury. Specifically, can providing support from trained peer health coaches via the SCI & U web-based self-management program increase health self-management among those within three years of a spinal cord injury with a planned discharge to or living in the community with SCI for less than two years in the province of British Columbia, Canada or the state of Connecticut, United States.

The main question it aims to answer is:

• Does the SCI & U web-based self-management program lower emotional distress and increase self-efficacy Researchers will compare those who participate in SCI & U with those who receive usual peer support after 6 months to see if the SCI & U program improves self-management knowledge, skills and self-efficacy and decreases secondary complications

Participants will:

  • engage in up to 14 online sessions, each of which lasts about an hour with a peer health coach trained in motivational interviewing, goal setting and brief action planning. During sessions, they may also review resources and create follow up plans on the online platform on health management topics
  • complete an interviewer administered survey at baseline, 6 and 12 months

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5J 2L4
        • Recruiting
        • Department of Physical Therapy, University of Toronto
        • Contact:
  • United States
    • Connecticut
      • Milford, Connecticut, United States, 06460
        • Recruiting
        • Spinal Cord Injury Association of Connecticut
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years and older, with a planned discharge to or living in community with SCI for no more than three years since injury and with the ability to speak and understand English

Exclusion Criteria:

  • not a member of or willing to become a member of SCI BC or SCIACT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCI&U self-management program
Following recruitment intervention participants will be scheduled for an orientation session to become better acquainted with the health coaching program and the associated platform's features. Participants will then be partnered with their peer health coach. In the first videoconference session, participants will identify priority issues related to their health and transitioning to home. They will work through goal-setting, problem solving and create action plans for behaviour change. Online coaching sessions are expected to cover a health-related topic and a self-management skill topic and will have an expected duration of 45 to 60 minutes. The selection of topics and the order will be determined jointly.
Behavioral: web-based spinal cord injury self-management program

Peer health coaches will be recruited from the United Spinal Connecticut Chapter and SCI BC. They will be at least 5 years post-SCI and will be certified in brief action planning and in Mental Health First Aid.

Online coaching sessions are expected to cover a health-related topic (eg. bladder, bowel, skin, pain, healthy eating, physical activity or stress, anxiety and depression etc) and a self-management skill topic (eg.action planning, goal setting, problem-solving, mood management, navigating the health care system, communicating with health care providers). To ensure we meet the unique needs of participants, the coach and participant will determine jointly how many sessions to spend on a topic. In addition, coaches will be able to link relevant information and resources contained in the resource library to each session.
Active Comparator: Wait list control
Control group will be offered the existing peer support program from the United Spinal Connecticut Chapter or SCI BC
Behavioral: Peer support
Existing peer support program from the United Spinal Connecticut Chapter or SCI BC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional Distress Subscale in Health Education Impact Questionnaire
Time Frame: From baseline assessment to 6 months followup
The Emotional Distress construct measures overall negative affect including worry, depression and anger.
From baseline assessment to 6 months followup

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Directed Activities in Health Education Impact Questionnaire
Time Frame: From baseline assessment to 6 months followup
From baseline assessment to 6 months followup
Positive and Active Engagement in Life in Health Education Impact Questionnaire
Time Frame: From baseline assessment to 6 months followup
From baseline assessment to 6 months followup
Self-monitoring and Insight in Health Education Impact Questionnaire
Time Frame: From baseline assessment to 6 months followup
From baseline assessment to 6 months followup
Constructive Attitudes and Approaches in Health Education Impact Questionnaire
Time Frame: From baseline assessment to 6 months followup
From baseline assessment to 6 months followup
Skill and Technique Acquisition in Health Education Impact Questionnaire
Time Frame: From baseline assessment to 6 months followup
From baseline assessment to 6 months followup
Social Integration and Support in Health Education Impact Questionnaire
Time Frame: From baseline assessment to 6 months followup
From baseline assessment to 6 months followup
Health Services Navigation in Health Education Impact Questionnaire
Time Frame: From baseline assessment to 6 months followup
From baseline assessment to 6 months followup
The Patient Activation Measure - (PAM) Survey
Time Frame: From baseline assessment to 6 months followup
The Patient Activation Measure (PAM) is a commercial product which assesses an individual's knowledge, skill, and confidence for managing one's health and healthcare. The PAM survey measures patients on a 0-100 scale and can segment patients into one of four activation levels. Individuals who measure high on this assessment typically understand the importance of taking a pro-active role in managing their health and have the skills and confidence to do so.
From baseline assessment to 6 months followup
Moorong Self-Efficacy Scale
Time Frame: From baseline assessment to 6 months followup

Measures self-efficacy in performing functional activities of daily living in individuals with SCI.

Consists of two factors: daily activities (e.g., I can maintain my personal hygiene with or without help), and social functioning (e.g., I can enjoy spending time with my friends)
From baseline assessment to 6 months followup
Secondary Conditions Scale
Time Frame: From baseline assessment to 6 months followup
A 16-item self-report measure that targets secondary conditions associated with SCI that impact health on a 4-point scale from "not experienced in the last 3 months" to significant or chronic problem"
From baseline assessment to 6 months followup
NIH Toolbox Loneliness Scale
Time Frame: From baseline assessment to 6 months followup
From baseline assessment to 6 months followup
System Usability Scale
Time Frame: From baseline assessment to 6 months followup
This scale was designed to evaluate the usability of interactive systems flexibly and expediently.
From baseline assessment to 6 months followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Investigators

  • Principal Investigator: Susan Jaglal, PhD, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 977608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared only for those who consent to their data being shared. The data will be deposited into a database. Any information that may identify an individual (e.g., name, address, phone number) will not be shared. In addition to data on outcome measures, descriptive variables and covariates, data describing participation in the intervention also will be shared. This will include number of sessions participants completed, length of sessions, topics discussed and if brief action plan was developed and goals set.

IPD Sharing Time Frame

IPD will be available in January 2028 which provides 1 year for publication of the main study results in a peer-reviewed journal article

IPD Sharing Access Criteria

We will make the content available publicly. This will include analytic datasets with data on outcome measures, descriptive variables and covariates and data describing participation in the intervention. Supporting information including the SAP and ICF will also be made available. Data will be deposited in the University of Toronto Dataverse which is a research data repository. Files will held in a secure environment on Canadian servers.

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injury

Clinical Trials on web-based spinal cord injury self-management program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe