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

NCT04474171 | Completed

• 2 other identifiers: 505419399095
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months after baseline

Secondary Outcomes (11)

• Secondary Conditions Scale

  6 and 12 months after baseline

• University of Washington Self-Efficacy Scale for People with Disabilities and Chronic Conditions: Short Form

  6 and 12 months after baseline

• International Spinal Cord Injury Datasets Quality of Life Basic Dataset-Data Form (Version 1.0)

  6 and 12 months after baseline

• SCI-QOL Resilience Short Form

  6 and 12 months after baseline

• Personal Health Questionnaire Depression Scale (PHQ-8)

  6 and 12 months after baseline

Study Arms (2)

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.

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)

Interventions

SCI&U online health coaching program BEHAVIORAL

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

SCI&U Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Toronto

Toronto, Ontario, M5G 1V7, Canada

Location

Related Publications (1)

• 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. doi: 10.1186/s40814-026-01769-y. Online ahead of print.

  PMID: 41593819 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Susan B Jaglal, PhD

  Professor

  PRINCIPAL INVESTIGATOR

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: July 13, 2020
• First Posted: July 16, 2020
• Study Start: October 16, 2019
• Primary Completion: April 21, 2022
• Study Completion: June 20, 2022
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: after publication of main study manuscript and for 5 years
• Access Criteria: need permission from PI

Locations

CA (1)