Clinical trial NCT04474171: An Online Self-management Program for Spinal Cord Injury: Feasibility Study of SCI&U
Official title: An Online Self-management Program for Spinal Cord Injury: Feasibility Study of SCI&U
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-07-16
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. ≥ 6 months post-injury to allow time to adjust to injury;
2. living in the community;
3. age ≥18 years;
4. ability to speak and read English and
5. have a primary care physician

Exclusion Criteria:

1. currently participating in another formal self-management program and
2. self-report of physician diagnosed concurrent traumatic brain injury

Primary outcomes:
measure: Skill and Technique Acquisition Scale from the Health Education Impact Questionnaire
timeFrame: 6 and 12 months after baseline
measure: Health Care Utilization: Cumulative days re-hospitalized 12 months after baseline
timeFrame: 12 months after baseline
Secondary outcomes:
measure: Secondary Conditions Scale
timeFrame: 6 and 12 months after baseline
measure: University of Washington Self-Efficacy Scale for People with Disabilities and Chronic Conditions: Short Form
timeFrame: 6 and 12 months after baseline
measure: International Spinal Cord Injury Datasets Quality of Life Basic Dataset-Data Form (Version 1.0)
timeFrame: 6 and 12 months after baseline
measure: SCI-QOL Resilience Short Form
timeFrame: 6 and 12 months after baseline
measure: Personal Health Questionnaire Depression Scale (PHQ-8)
timeFrame: 6 and 12 months after baseline
measure: Self-reported Emergency department visits
timeFrame: 6 and 12 months
measure: Social/Role Activities Limitations
timeFrame: 6 and 12 months after baseline
measure: Positive and Active Engagement in Life from the Health Education Impact Questionnaire
timeFrame: 6 and 12 months after baseline
measure: Self Monitoring and Insight from the Health Education Impact Questionnaire
timeFrame: 6 and 12 months after baseline
measure: Health Services Navigation from the Health Education Impact Questionnaire
timeFrame: 6 and 12 months after baseline
measure: Emotional Distress from the Health Education Impact Questionnaire
timeFrame: 6 and 12 months after baseline
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: Professor
name: Susan B Jaglal, PhD
role: PRINCIPAL_INVESTIGATOR
References: