Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Mobile Application
  • Self Management
  • Spinal Cord Injuries
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Mixed-methods, rater-blinded, randomized controlled trial with a stepped wedge design (i.e., delayed intervention control group). The qualitative portion will consist of semi-structured interviews with a sub-sample of the participants.Masking: Single (Outcomes Assessor)Masking Description: Since it is not possible to blind the participants or the interventionists, a single blind study design will be employed in which data collectors are blinded to participants' group allocation.Primary Purpose: Supportive Care

Participation Requirements

Age
Between 19 years and 125 years
Gender
Both males and females

Description

Most people with spinal cord injury (SCI) will develop debilitating secondary conditions, such as autonomic dysreflexia and pressure ulcers. Self-management programs, which recognize patients' central role in managing their condition, have been found to improve health-outcomes in a variety of popula...

Most people with spinal cord injury (SCI) will develop debilitating secondary conditions, such as autonomic dysreflexia and pressure ulcers. Self-management programs, which recognize patients' central role in managing their condition, have been found to improve health-outcomes in a variety of populations, such as those living with diabetes and asthma. Given the increase in health care costs and funding constraints, alternative self-management interventions are being explored, such as the use of electronic health (e-health) treatments. Despite the potential benefits of self-management among people with SCI, the investigators were able to identify little experimental research in this area. Our goal is to evaluate the efficacy of a broad-based self-management application ("app") the investigators have developed to facilitate the improvement of self-management skills among community-dwelling individuals with SCI. The primary outcome is attainment of self-selected self-management goals. Secondary outcomes include general and self-management self-efficacy, secondary conditions related to SCI, self-reported healthcare utilization, self-reported health events, and app usage data. During the preliminary phase of the study, participants (SCI clinicians and patients with SCI) reported favourable usage of the self-management app and unanimously agreed it would benefit people with SCI. With the ubiquity of portable electronic devices, an opportunity exists to help participants and informal caregivers navigate the journey from rehabilitation to integration back into the community. The research team will use both quantitative and qualitative methods involving a rater-blinded, randomized controlled trial with a stepped wedge design and semi-structured interviews. The participant-specific intervention will involve the use of the self-management app focusing on the self-management of SCI accompanied by five to six in-person or telephone/Skype contacts that will occur over a three-month period. Our proposal is original in that it will be one of the few randomized controlled trials in the area of e-health interventions for self-care management for those with SCI. Although the use of qualitative and qualitative methods has been recommended in randomized controlled trials, relatively few studies have used this design, so the proposed study may provide a model for assessing the effectiveness of other self-management interventions. The overall purpose of the study is to develop an effective self-management application that can be used to promote self-management in a variety of populations and is less resource intensive. This app would be complementary to other complication specific apps that are more in-depth and expensive to deliver, while providing an accessible and affordable form of tertiary prevention for those who develop secondary complications.

Tracking Information

NCT #
NCT03140501
Collaborators
The Craig H. Neilsen Foundation
Investigators
Principal Investigator: Ben Mortenson, PhD University of British Columbia