NCT06677905

Brief 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. 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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
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 Progress65%
Feb 2025Dec 2026

First Submitted

Initial submission to the registry

November 4, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

February 21, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

November 4, 2024

Last Update Submit

August 28, 2025

Conditions

Keywords

peer supportself-managementspinal cord injurynewly injuredweb-based program

Outcome Measures

Primary Outcomes (1)

  • Emotional Distress Subscale in Health Education Impact Questionnaire

    The Emotional Distress construct measures overall negative affect including worry, depression and anger.

    From baseline assessment to 6 months followup

Secondary Outcomes (12)

  • Health Directed Activities in Health Education Impact Questionnaire

    From baseline assessment to 6 months followup

  • Positive and Active Engagement in Life in Health Education Impact Questionnaire

    From baseline assessment to 6 months followup

  • Self-monitoring and Insight in Health Education Impact Questionnaire

    From baseline assessment to 6 months followup

  • Constructive Attitudes and Approaches in Health Education Impact Questionnaire

    From baseline assessment to 6 months followup

  • Skill and Technique Acquisition in Health Education Impact Questionnaire

    From baseline assessment to 6 months followup

  • +7 more secondary outcomes

Study Arms (2)

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.

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

Behavioral: Peer support

Interventions

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.

SCI&U self-management program
Peer supportBEHAVIORAL

Existing peer support program from the United Spinal Connecticut Chapter or SCI BC

Wait list control

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Spinal Cord Injury Association of Connecticut

Milford, Connecticut, 06460, United States

RECRUITING

Department of Physical Therapy, University of Toronto

Toronto, Ontario, M5J 2L4, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Susan Jaglal, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Jaglal, PhD

CONTACT

Diana Pernigotti

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 7, 2024

Study Start

February 21, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP, ICF
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
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.

Locations