Spinal Cord InjuriesSCI&UNCT04474171
An Online Self-management Program for Spinal Cord Injury: Feasibility Study of SCI&U
A study testing SCI&U online health coaching program in people with Spinal Cord Injuries, run by University of Toronto at 1 site in Canada.
Trial summary
Managing a spinal cord injury (SCI) is a life-long process. Within the first year of injury, more than 50% of people discharged with a SCI may require re-hospitalization due to a secondary complication, such as a urinary tract infection, pressure ulcer or pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- SCI&U online health coaching program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteCanada
- Study dates
- 16 Oct 2019to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- ≥ 6 months post-injury to allow time to adjust to injury;
- living in the community;
- age ≥18 years;
- ability to speak and read English and
- have a primary care physician
Who cannot join
- currently participating in another formal self-management program and
- self-report of physician diagnosed concurrent traumatic brain injury
Trial locations and contacts
1 site in 1 country.
About this study
Managing a spinal cord injury (SCI) is a life-long process. Within the first year of injury, more than 50% of people discharged with a SCI may require re-hospitalization due to a secondary complication, such as a urinary tract infection, pressure ulcer or pneumonia. Even 20 years post-injury, re-hospitalization rates remain over 30%. While re-hospitalization rates in Canada have remained high for more than 10 years, the length of stay in inpatient rehabilitation has decreased dramatically, thereby limiting the time for provision of health information and skill acquisition in the inpatient rehabilitation setting. There is growing evidence from two recent pilot trials to suggest that self-management programs that provide appropriate health information, skills and telephone-based support for community-dwelling patients with SCI improves health behaviors and leads to reductions in re-hospitalization.
Goals/Research Aim: To conduct a pilot RCT (feasibility study) that will inform the design of a definitive RCT to determine whether an online self-management program incorporating trained peer health coaches (called "SCI\&U") compared to usual care will result in improved self-management skills (short-term outcome) and lead to reduced days of hospitalization (long-term outcome) due to secondary complications.This pilot study is a two-group RCT with an embedded qualitative component. The target population is adults with SCI who have been discharged from inpatient rehabilitation and living in the community. Sixty subjects will be recruited from across Canada with a focus on British Columbia and Ontario and randomly assigned to the SCI\&U intervention or usual care.
Evaluations will occur at baseline, 2, 6, and 12 months.
Read the detailed description
Background and Importance: Managing a spinal cord injury (SCI) is a life-long process. Within the first year of injury, more than 50% of people discharged with a SCI may require re-hospitalization due to a secondary complication, such as a urinary tract infection, pressure ulcer or pneumonia. Even 20 years post-injury, re-hospitalization rates remain over 30%. While re-hospitalization rates in Canada have remained high for more than 10 years, the length of stay in inpatient rehabilitation has decreased dramatically, thereby limiting the time for provision of health information and skill acquisition in the inpatient rehabilitation setting. There is growing evidence from two recent pilot trials to suggest that self-management programs that provide appropriate health information, skills and telephone-based support for community-dwelling patients with SCI improves health behaviors and leads to reductions in re-hospitalization.
Goals/Research Aim: To conduct a pilot RCT (feasibility study) that will inform the design of a definitive RCT to determine whether an online self-management program incorporating trained peer health coaches (called "SCI\&U") compared to usual care will result in improved self-management skills (short-term outcome) and lead to reduced days of hospitalization (long-term outcome) due to secondary complications.
Secondary outcomes include self-efficacy for self-management, depression, resilience, number and severity of secondary conditions, health-related quality of life, and patient-reported unplanned ED visits.
Methods/Approaches/Expertise: This pilot study is a two-group RCT with an embedded qualitative component. The target population is adults with SCI who have been discharged from inpatient rehabilitation and living in the community. Sixty subjects will be recruited from across Canada with a focus on British Columbia and Ontario and randomly assigned to the SCI\&U intervention or usual care.
Evaluations will occur at 0, 2, 6, and 12 months. At 6 and 12 months, interviews will be conducted with SCI\&U participants and at 12 months focus groups with health coaches, consumer organizations, and rehabilitation hospital staff to explore the feasibility of the study protocol, understand perceived costs and benefits of SCI\&U, and sustainability considerations. The creation of the SCI\&U online self-management program is based on a number of studies conducted by the research team. The investigators initially determined implementation considerations in terms of need, content and mode of delivery in a mixed methods study of individuals with SCI, their family members, and hospital managers. The SCI\&U team includes rehabilitation researchers, persons with SCI, community-based organizations (SCI BC, SCI Ontario and Praxis Spinal Cord Institute) and clinicians from across Canada. The investigators used an integrated knowledge translation approach where users with SCI co-designed and developed the prototype. The investigators have completed usability testing on 20 participants and trained 5 health coaches and had an additional 11 individuals living with SCI complete 6 sessions of health coaching using the SCI\&U prototype.
Expected Outcomes: The findings from this feasibility study are integral to the development of a definitive RCT. It is anticipated that SCI\&U would not only reduce secondary complications and subsequent inappropriate health care use, but also improve the quality of life for individuals with SCI.
- Conditions
- Spinal Cord Injuries
- Being tested
- SCI&U online health coaching 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.
SCI&U online health coaching programBehavioural
Online secure videoconferencing health coaching platform with resource library to promote self-management. Maximum number of sessions is 14 over 6 months and covers health related topics to reduce secondary complications
| Study group | Role | What they receive |
|---|---|---|
| SCI&U Intervention | Experimental | The SCI\&U online platform has a resource library, secure videoconferencing, and tools to support one-on-one health coaching. Health coaches are certified in motivational interviewing and have lived in the community with SCI for more than five years. In the first session, participants identify priority issues related to their health and target management of secondary conditions specific to SCI. They will work through goal setting, problem solving activities and create action plans for behaviour change, which will be securely stored. The intervention will be a maximum of 14 sessions over 6 months. Each session will cover a health-related topic (bladder, bowel, skin, pain, healthy eating, physical activity or stress, anxiety and depression) and a self-management skill topic (action planning, goal setting, problem-solving, mood management, navigating the health care system and communicating with health care providers) with an expected duration of 30 to 45 minutes. Receives: Behavioral: SCI&U online health coaching program |
| Waitlist Control | No intervention | Usual health care and be offered the SCI\&U program at the end of the 12-month follow-up period (wait-list control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skill and Technique Acquisition Scale from the Health Education Impact Questionnaire
4-item scale that captures knowledge based skills and techniques that persons acquire to help them cope with health problems. It is a 4-point Likert scale (1-4) ranging from strongly disagree to strongly agree. Score is the sum of the 4 items. A higher score means a better outcome.
Measured: 6 and 12 months after baseline
Health Care Utilization: Cumulative days re-hospitalized 12 months after baseline
Self-report of total days hospitalized for each participant will be obtained as the primary health care utilization outcome. This will be measured at 6 and 12 months after baseline with the qeustion "how many total NIGHTS did you spend in the hospital in the past 6 months? A higher total number of days means a worse outcome.
Measured: 12 months after baseline
Secondary outcomes (11)
Secondary Conditions Scale
This is a 16-item self report measure that targets secondary conditions associated with SCI that impact health. The response options are a 4-point scale (0 - not experienced in the last 3 months or is an insignificant problem, 1 mild or infrequent problem, 2 moderate or occasional problem, 3 significant or chronic problem. Score is the sum of the 16 items. A higher total score means a worse outcome.
Measured: 6 and 12 months after baseline
University of Washington Self-Efficacy Scale for People with Disabilities and Chronic Conditions: Short Form
6-item self-report questionnaire rating confidence in self-management skills on a 5-point Likert scale ranging from "0" not at all to '4" completely. Score is the sum of the 6 items. A higher score means a better outcome (self-efficacy).
Measured: 6 and 12 months after baseline
International Spinal Cord Injury Datasets Quality of Life Basic Dataset-Data Form (Version 1.0)
3 questions from the International SCI QOL Basic dataset that rates satisfaction with general QOL, physical and psychological health on an 11-point Likert scale with "0" being completely dissatisfied" to '10" completely satisfied. A higher score means a better outcome.
Measured: 6 and 12 months after baseline
SCI-QOL Resilience Short Form
8-item measure of adaptation or adjustment after the injury. The context for all resilience items is "in the past 7 day...". The response options are a 5-point Likert scale ranging from "1" Never to "5" Always. Score is the sum of the 8 items. A higher score means a better outcome.
Measured: 6 and 12 months after baseline
Personal Health Questionnaire Depression Scale (PHQ-8)
8-item Likert scale measuring depression symptoms. Response options range from "0" not at all to "3" nearly every day. Score is the sum of the 8 items. A higher score means a worse outcome. A score of 10 or greater is considered major depression, 20 or more is severe major depression symptoms.
Measured: 6 and 12 months after baseline
Self-reported Emergency department visits
self-report number of emergency department visits in the past 6 months. The question is "In the past 6 months, how many times did you go to a hospital emergency room?" A higher number indicates more visits and means a worse outcome
Measured: 6 and 12 months
Social/Role Activities Limitations
4-item self-report measure of limitations within the past 2 weeks. This is scored on a 5-point Likert scale with "0" as not at all and '4" almost daily. The score of the scale is he mean of the four items. A higher scores indicates greater activities limitations.
Measured: 6 and 12 months after baseline
Positive and Active Engagement in Life from the Health Education Impact Questionnaire
5-item scale assesses motivation to be active and engaging in life-fulfilling activities as a result of self-management program involvement
Measured: 6 and 12 months after baseline
Self Monitoring and Insight from the Health Education Impact Questionnaire
6-item scale captures the individuals' ability to monitor their condition, and their physical/emotional responses that lead to insights and actions to self manage
Measured: 6 and 12 months after baseline
Health Services Navigation from the Health Education Impact Questionnaire
5-item scale captures individual's understanding of and ability to interact with health professionals and confidence and ability to communicate and negotiate to get needs met
Measured: 6 and 12 months after baseline
Emotional Distress from the Health Education Impact Questionnaire
6-item scale measures overall negative affective responses to illness including anxiety, anger, and depression
Measured: 6 and 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start16 Oct 2019
- Primary completion21 Apr 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Susan Jaglal, University of Toronto
- Investigators
- Susan B Jaglal, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474171
- Sponsor's protocol ID
- 505419
- Other IDs
- 399095
- Acronym
- SCI&U
- Status last verified
- Dec 2024
- First submitted
- 13 Jul 2020
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: aggregated data from descriptive and outcomes measures will be shared
Publications
Jaglal SB, Allin SJ, Craven BC, Guilcher SJT, Linassi AG, McBride CB, Moineddin R, Mortenson WB, Munce S, Salbach NM, Shepherd JD, Sweet SN, Thorson T, Tomasone JR. A pilot randomised controlled trial of the Spinal Cord Injury and You (SCI&U) online peer health coaching self-management program. Pilot Feasibility Stud. 2026 Jan 28;12(1):29. doi: 10.1186/s40814-026-01769-y.
PubMed 41593819
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Self-management Program for Spinal Cord Injury: Feasibility Study of SCI&U
- ClinicalTrials.gov ID
- NCT04474171
- Acronym / sponsor ID
- SCI&U / 505419
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 16 Jul 2020 (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.
Managing a spinal cord injury (SCI) is a life-long process. Within the first year of injury, more than 50% of people discharged with a SCI may require re-hospitalization due to a secondary complication, such as a urinary tract infection, pressure ulcer or pneumonia. Even 20 years post-injury, re-hospitalization rates remain over 30%. While re-hospitalization rates in Canada have remained high for more than 10 years, the length of stay in inpatient rehabilitation has decreased dramatically, thereby limiting the time for provision of health information and skill acquisition in the inpatient rehabilitation setting. There is growing evidence from two recent pilot trials to suggest that self-management programs that provide appropriate health information, skills and telephone-based support for community-dwelling patients with SCI improves health behaviors and leads to reductions in re-hospitalization.
Goals/Research Aim: To conduct a pilot RCT (feasibility study) that will inform the design of a definitive RCT to determine whether an online self-management program incorporating trained peer health coaches (called "SCI\&U") compared to usual care will result in improved self-management skills (short-term outcome) and lead to reduced days of hospitalization (long-term outcome) due to secondary complications.This pilot study is a two-group RCT with an embedded qualitative component. The target population is adults with SCI who have been discharged from inpatient rehabilitation and living in the community. Sixty subjects will be recruited from across Canada with a focus on British Columbia and Ontario and randomly assigned to the SCI\&U intervention or usual care.
Evaluations will occur at baseline, 2, 6, and 12 months.
Detailed description
Background and Importance: Managing a spinal cord injury (SCI) is a life-long process. Within the first year of injury, more than 50% of people discharged with a SCI may require re-hospitalization due to a secondary complication, such as a urinary tract infection, pressure ulcer or pneumonia. Even 20 years post-injury, re-hospitalization rates remain over 30%. While re-hospitalization rates in Canada have remained high for more than 10 years, the length of stay in inpatient rehabilitation has decreased dramatically, thereby limiting the time for provision of health information and skill acquisition in the inpatient rehabilitation setting. There is growing evidence from two recent pilot trials to suggest that self-management programs that provide appropriate health information, skills and telephone-based support for community-dwelling patients with SCI improves health behaviors and leads to reductions in re-hospitalization.
Goals/Research Aim: To conduct a pilot RCT (feasibility study) that will inform the design of a definitive RCT to determine whether an online self-management program incorporating trained peer health coaches (called "SCI\&U") compared to usual care will result in improved self-management skills (short-term outcome) and lead to reduced days of hospitalization (long-term outcome) due to secondary complications.
Secondary outcomes include self-efficacy for self-management, depression, resilience, number and severity of secondary conditions, health-related quality of life, and patient-reported unplanned ED visits.
Methods/Approaches/Expertise: This pilot study is a two-group RCT with an embedded qualitative component. The target population is adults with SCI who have been discharged from inpatient rehabilitation and living in the community. Sixty subjects will be recruited from across Canada with a focus on British Columbia and Ontario and randomly assigned to the SCI\&U intervention or usual care.
Evaluations will occur at 0, 2, 6, and 12 months. At 6 and 12 months, interviews will be conducted with SCI\&U participants and at 12 months focus groups with health coaches, consumer organizations, and rehabilitation hospital staff to explore the feasibility of the study protocol, understand perceived costs and benefits of SCI\&U, and sustainability considerations. The creation of the SCI\&U online self-management program is based on a number of studies conducted by the research team. The investigators initially determined implementation considerations in terms of need, content and mode of delivery in a mixed methods study of individuals with SCI, their family members, and hospital managers. The SCI\&U team includes rehabilitation researchers, persons with SCI, community-based organizations (SCI BC, SCI Ontario and Praxis Spinal Cord Institute) and clinicians from across Canada. The investigators used an integrated knowledge translation approach where users with SCI co-designed and developed the prototype. The investigators have completed usability testing on 20 participants and trained 5 health coaches and had an additional 11 individuals living with SCI complete 6 sessions of health coaching using the SCI\&U prototype.
Expected Outcomes: The findings from this feasibility study are integral to the development of a definitive RCT. It is anticipated that SCI\&U would not only reduce secondary complications and subsequent inappropriate health care use, but also improve the quality of life for individuals with SCI.
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 Intervention | Experimental | Behavioral: SCI&U online health coaching programThe SCI\&U online platform has a resource library, secure videoconferencing, and tools to support one-on-one health coaching. Health coaches are certified in motivational interviewing and have lived in the community with SCI for more than five years. In the first session, participants identify priority issues related to their health and target management of secondary conditions specific to SCI. They will work through goal setting, problem solving activities and create action plans for behaviour change, which will be securely stored. The intervention will be a maximum of 14 sessions over 6 months. Each session will cover a health-related topic (bladder, bowel, skin, pain, healthy eating, physical activity or stress, anxiety and depression) and a self-management skill topic (action planning, goal setting, problem-solving, mood management, navigating the health care system and communicating with health care providers) with an expected duration of 30 to 45 minutes. |
| Waitlist Control | No intervention | –Usual health care and be offered the SCI\&U program at the end of the 12-month follow-up period (wait-list control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 6 months post-injury to allow time to adjust to injury;
- living in the community;
- age ≥18 years;
- ability to speak and read English and
- have a primary care physician
Key exclusion criteria (2 listed)
- currently participating in another formal self-management program and
- self-report of physician diagnosed concurrent traumatic brain injury
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 |
|---|---|---|
| SCI&U online health coaching programOnline secure videoconferencing health coaching platform with resource library to promote self-management. Maximum number of sessions is 14 over 6 months and covers health related topics to reduce secondary complications | Behavioural | SCI&U Intervention |
Primary outcome
Skill and Technique Acquisition Scale from the Health Education Impact Questionnaire
Time frame: 6 and 12 months after baseline
4-item scale that captures knowledge based skills and techniques that persons acquire to help them cope with health problems. It is a 4-point Likert scale (1-4) ranging from strongly disagree to strongly agree. Score is the sum of the 4 items. A higher score means a better outcome.
Health Care Utilization: Cumulative days re-hospitalized 12 months after baseline
Time frame: 12 months after baseline
Self-report of total days hospitalized for each participant will be obtained as the primary health care utilization outcome. This will be measured at 6 and 12 months after baseline with the qeustion "how many total NIGHTS did you spend in the hospital in the past 6 months? A higher total number of days means a worse outcome.
11 secondary outcomes
Secondary Conditions Scale
Time frame: 6 and 12 months after baseline
University of Washington Self-Efficacy Scale for People with Disabilities and Chronic Conditions: Short Form
Time frame: 6 and 12 months after baseline
International Spinal Cord Injury Datasets Quality of Life Basic Dataset-Data Form (Version 1.0)
Time frame: 6 and 12 months after baseline
SCI-QOL Resilience Short Form
Time frame: 6 and 12 months after baseline
Personal Health Questionnaire Depression Scale (PHQ-8)
Time frame: 6 and 12 months after baseline
Self-reported Emergency department visits
Time frame: 6 and 12 months
Social/Role Activities Limitations
Time frame: 6 and 12 months after baseline
Positive and Active Engagement in Life from the Health Education Impact Questionnaire
Time frame: 6 and 12 months after baseline
Self Monitoring and Insight from the Health Education Impact Questionnaire
Time frame: 6 and 12 months after baseline
Health Services Navigation from the Health Education Impact Questionnaire
Time frame: 6 and 12 months after baseline
Emotional Distress from the Health Education Impact Questionnaire
Time frame: 6 and 12 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 41593819Jaglal SB, Allin SJ, Craven BC, Guilcher SJT, Linassi AG, McBride CB, Moineddin R, Mortenson WB, Munce S, Salbach NM, Shepherd JD, Sweet SN, Thorson T, Tomasone JR. A pilot randomised controlled trial of the Spinal Cord Injury and You (SCI&U) online peer health coaching self-management program. Pilot Feasibility Stud. 2026 Jan 28;12(1):29. doi: 10.1186/s40814-026-01769-y.
- Individual participant dataSharing planned: Yes. aggregated data from descriptive and outcomes measures will be shared
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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. This study is not recruiting at the moment.
Susan B Jaglal, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCI&U online health coaching program in people with Spinal Cord Injuries, run by University of Toronto at 1 site in Canada.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skill and Technique Acquisition Scale from the Health Education Impact Questionnaire (time frame: 6 and 12 months after baseline). The study lists 2 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 NCT04474171, which also lists 1 linked publication.
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 6 Dec 2024.