Spinal Cord InjurySCIU2NCT06677905
SCI&U Peer Health Coaching Program for Individuals Newly Discharged From Inpatient Rehabilitation
A study testing web-based spinal cord injury self-management program and Peer support in people with Spinal Cord Injury, run by University of Toronto at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- web-based spinal cord injury self-management program and Peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Feb 2025to 31 Dec 2026
- 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
Who may be able to join
- 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
Who cannot join
- not a member of or willing to become a member of SCI BC or SCIACT
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Spinal Cord Injury Association of Connecticut
Milford, Connecticut, 06460
Diana Pernigotti, 203-284-2910, dianasciu@gmail.com
Canada1 site, 1 recruiting
- Recruiting
Department of Physical Therapy, University of Toronto
Toronto, Ontario, M5J 2L4
Susan Jaglal, PhD, 416-946-8641, susan.jaglal@utoronto.ca
About this study
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:
Read more
- 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
- Conditions
- Spinal Cord Injury
- Being tested
- web-based spinal cord injury self-management program, Peer support
- Keywords
- peer support, self-management, spinal cord injury, newly injured, web-based program
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based spinal cord injury self-management programBehavioural
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.
Peer supportBehavioural
Existing peer support program from the United Spinal Connecticut Chapter or SCI BC
| Study group | Role | What they receive |
|---|---|---|
| SCI&U self-management program | Experimental | 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. Receives: Behavioral: web-based spinal cord injury self-management program |
| Wait list control | Active comparator | Control group will be offered the existing peer support program from the United Spinal Connecticut Chapter or SCI BC Receives: Behavioral: Peer support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Distress Subscale in Health Education Impact Questionnaire
The Emotional Distress construct measures overall negative affect including worry, depression and anger.
Measured: From baseline assessment to 6 months followup
Secondary outcomes (12)
Health Directed Activities in Health Education Impact Questionnaire
Measured: From baseline assessment to 6 months followup
Positive and Active Engagement in Life in Health Education Impact Questionnaire
Measured: From baseline assessment to 6 months followup
Self-monitoring and Insight in Health Education Impact Questionnaire
Measured: From baseline assessment to 6 months followup
Constructive Attitudes and Approaches in Health Education Impact Questionnaire
Measured: From baseline assessment to 6 months followup
Skill and Technique Acquisition in Health Education Impact Questionnaire
Measured: From baseline assessment to 6 months followup
Social Integration and Support in Health Education Impact Questionnaire
Measured: From baseline assessment to 6 months followup
Health Services Navigation in Health Education Impact Questionnaire
Measured: From baseline assessment to 6 months followup
The Patient Activation Measure - (PAM) Survey
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.
Measured: From baseline assessment to 6 months followup
Moorong Self-Efficacy Scale
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)
Measured: From baseline assessment to 6 months followup
Secondary Conditions Scale
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"
Measured: From baseline assessment to 6 months followup
NIH Toolbox Loneliness Scale
Measured: From baseline assessment to 6 months followup
System Usability Scale
This scale was designed to evaluate the usability of interactive systems flexibly and expediently.
Measured: From baseline assessment to 6 months followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start21 Feb 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Jaglal, University of Toronto
- Investigators
- Susan Jaglal, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677905
- Sponsor's protocol ID
- 977608
- Acronym
- SCIU2
- Status last verified
- Aug 2025
- First submitted
- 4 Nov 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCI&U Peer Health Coaching Program for Individuals Newly Discharged From Inpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT06677905
- Acronym / sponsor ID
- SCIU2 / 977608
- Conditions
- Spinal Cord Injury
- Keywords
- peer support, self-management, spinal cord injury, newly injured, web-based program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Nov 2024 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCI&U self-management program | Experimental | Behavioral: web-based spinal cord injury self-management programFollowing 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. |
| Wait list control | Active comparator | Behavioral: Peer supportControl group will be offered the existing peer support program from the United Spinal Connecticut Chapter or SCI BC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- not a member of or willing to become a member of SCI BC or SCIACT
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 |
|---|---|---|
| web-based spinal cord injury self-management programPeer 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. | Behavioural | SCI&U self-management program |
| Peer supportExisting peer support program from the United Spinal Connecticut Chapter or SCI BC | Behavioural | Wait list control |
Primary outcome
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.
12 secondary outcomes
Health Directed Activities in Health Education Impact Questionnaire
Time frame: 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
Self-monitoring and Insight in Health Education Impact Questionnaire
Time frame: 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
Skill and Technique Acquisition in Health Education Impact Questionnaire
Time frame: 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
Health Services Navigation in Health Education Impact Questionnaire
Time frame: From baseline assessment to 6 months followup
The Patient Activation Measure - (PAM) Survey
Time frame: From baseline assessment to 6 months followup
Moorong Self-Efficacy Scale
Time frame: From baseline assessment to 6 months followup
Secondary Conditions Scale
Time frame: From baseline assessment to 6 months followup
NIH Toolbox Loneliness Scale
Time frame: From baseline assessment to 6 months followup
System Usability Scale
Time frame: From baseline assessment to 6 months followup
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 5 Sep 2025.
- Individual participant dataSharing planned: Yes. 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.
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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 Jaglal, PhD principal investigator
University of Toronto
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web-based spinal cord injury self-management program and Peer support in people with Spinal Cord Injury, run by University of Toronto at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 5 Sep 2025. 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, Canada. 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 Jaglal, PhD (416-946-8641, susan.jaglal@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Distress Subscale in Health Education Impact Questionnaire (time frame: From baseline assessment to 6 months followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2025.