An Online Self-management Program for Spinal Cord Injury: Feasibility Study of SCI&U

Spinal Cord Injuries Clinical Trial

— SCI&U  

Official title:

An Online Self-management Program for Spinal Cord Injury: Feasibility Study of SCI&U

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474171
• Other study ID #: 505419
• Secondary ID: 399095
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: July 2020
• Source: University of Toronto
• Contact: Susan B Jaglal, PhD
• Phone: 416 946-3941
• Email: susan.jaglal[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• SCI&U online health coaching program
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

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skill and Technique Acquisition Scale from the Health Education Impact Questionnaire	It 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.	6 months after baseline
Primary	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.	12 months after baseline
Secondary	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.	6 months after baseline
Secondary	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).	6 months after baseline
Secondary	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.	6 months after baseline
Secondary	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.	6 months after baseline
Secondary	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.	6 months after baseline
Secondary	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	6 and 12 months
Secondary	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.	6 months after baseline

External Links

•   study website