Clinical trial NCT03140501: Improving Self-Management Skills Among People With Spinal Cord Injury
Official title: Improving Self-Management Skills Among People With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Self-Management
Mobile Application
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2017-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of our study is to evaluate the use of a self-management application ("app") that the investigators have developed to help facilitate self-management among individuals with SCI who live in the community. The main purpose is to create and fulfill individual self-management goals. Other purposes include improving self-management and health conditions related to SCI.

During the initial phase, participants (SCI clinicians and patients with SCI) reported positive usage of the self-management app and all agreed it would benefit people with SCI. With the widespread use of portable electronic devices, an opportunity exists to help patients and informal caregivers on the journey from rehabilitation to integration back into the community. The investigators will use a randomized controlled trial (randomly putting participants into two groups), including both surveys and interviews. The study will involve the use of the app that focuses on the self-management of SCI, along with five to six in-person or telephone meetings over a three-month period.

Our proposal is original in that it will be one of the few randomized control trials for e-health interventions for self-care management for those with SCI. The overall goals of the study is to develop an affordable self-management app that can be used to encourage self-management in people living with SCI. This app would be used along with other health problem specific apps that are more detailed and expensive, while helping participants to manage their long-term health problems related to their SCI in an easily usable and affordable form.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Have been discharged from inpatient rehabilitation following a spinal cord injury at least one year prior
* Are living in the community setting
* Are 19 years of age or over
* Speak, read, and write English
* Have reliable access to internet
* Are capable of providing your own informed consent

Exclusion Criteria:

* Are unable to provide informed consent (due to severe mental illness or traumatic brain injury)
* Have previously used a self-management mobile app focused on spinal cord injury (including SCI Health Storylines)
* Have cognitive impairments that impact memory, communication or ability to complete questionnaires.

Primary outcomes:
measure: Goal Attainment Scaling (GAS)
timeFrame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Secondary outcomes:
measure: Self-Efficacy for Managing Chronic Disease Scale
timeFrame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
measure: Spinal Cord Injury Secondary Conditions Scale
timeFrame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
measure: Self-Reported Healthcare Utilization
timeFrame: Throughout the study, up until the end-point (9 months)
measure: Spinal Cord Independence Measure III
timeFrame: At 0 months (baseline)
measure: American Spinal Injury Association Impairment Scale
timeFrame: At 0 months (baseline)
measure: Interpersonal Support Evaluation List (ISEL)
timeFrame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
measure: Technology Readiness Index
timeFrame: At 0 months (baseline)
measure: Leisure Time Physical Activity Questionnaire-SCI
timeFrame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
measure: Health Care Climate Questionnaire
timeFrame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
measure: Amount of informal/formal caregiving
timeFrame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Center
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ben Mortenson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mortenson WB, Mills PB, Adams J, Singh G, MacGillivray M, Sawatzky B. Improving Self-Management Skills Among People With Spinal Cord Injury: Protocol for a Mixed-Methods Study. JMIR Res Protoc. 2018 Nov 14;7(11):e11069. doi: 10.2196/11069.