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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Wait list control | Active Comparator | Control group will be offered the existing peer support program from the United Spinal Connecticut Chapter or SCI BC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| web-based spinal cord injury self-management program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan Jaglal, PhD | Contact | 416-946-8641 | susan.jaglal@utoronto.ca | |
| Diana Pernigotti | Contact | 203-284-2910 | dianasciu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Susan Jaglal, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spinal Cord Injury Association of Connecticut | Recruiting | Milford | Connecticut | 06460 | United States |
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 will be available in January 2028 which provides 1 year for publication of the main study results in a peer-reviewed journal article
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.
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Peer support | Behavioral | Existing peer support program from the United Spinal Connecticut Chapter or SCI BC |
|
| 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 |
| Social Integration and Support in Health Education Impact Questionnaire | From baseline assessment to 6 months followup |
| Health Services Navigation in Health Education Impact Questionnaire | 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. | 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) | 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" | From baseline assessment to 6 months followup |
| NIH Toolbox Loneliness Scale | From baseline assessment to 6 months followup |
| System Usability Scale | This scale was designed to evaluate the usability of interactive systems flexibly and expediently. | From baseline assessment to 6 months followup |
| Department of Physical Therapy, University of Toronto | Recruiting | Toronto | Ontario | M5J 2L4 | Canada |
|
| D014947 | Wounds and Injuries |