Improving Self-Management Skills Among People With Spinal Cord Injury

NCT ID: NCT03140501

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2022-12-31

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.

Conditions

Spinal Cord Injuries; Self-Management; Mobile Application

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Immediate Intervention

Participants randomized to this group will receive the intervention, the mobile application ("app"), immediately after baseline data are collected.

Group Type: EXPERIMENTAL

Mobile application ("app")

Intervention Type: DEVICE

The self-management app has 3 main features: 1) SCI-specific education modules; 2) a "circle-of-care" in which the users select health allies (formal and informal caregivers); and 3) a variety of tools to assist with goal identification, symptom/behaviour tracking, etc. The intervention will involve 5-6 contacts that occur over a 3-month period and ongoing use of the app. There will be 1 to 2 in-person sessions, where the principles of self-management are reviewed, self-management goals are identified, and features of the app are explained. Over the next month, there will be 2 follow-up contacts to review any questions/issues participants have. Participants can set additional goals during this time. Over the last 2 months, there will be monthly contacts to address the same issues.

Delayed intervention

Participants randomized to this group will receive the intervention, the mobile application ("app"), after a three month delay.

Group Type: OTHER

Mobile application ("app")

Intervention Type: DEVICE

The self-management app has 3 main features: 1) SCI-specific education modules; 2) a "circle-of-care" in which the users select health allies (formal and informal caregivers); and 3) a variety of tools to assist with goal identification, symptom/behaviour tracking, etc. The intervention will involve 5-6 contacts that occur over a 3-month period and ongoing use of the app. There will be 1 to 2 in-person sessions, where the principles of self-management are reviewed, self-management goals are identified, and features of the app are explained. Over the next month, there will be 2 follow-up contacts to review any questions/issues participants have. Participants can set additional goals during this time. Over the last 2 months, there will be monthly contacts to address the same issues.

Interventions

Mobile application ("app")

The self-management app has 3 main features: 1) SCI-specific education modules; 2) a "circle-of-care" in which the users select health allies (formal and informal caregivers); and 3) a variety of tools to assist with goal identification, symptom/behaviour tracking, etc. The intervention will involve 5-6 contacts that occur over a 3-month period and ongoing use of the app. There will be 1 to 2 in-person sessions, where the principles of self-management are reviewed, self-management goals are identified, and features of the app are explained. Over the next month, there will be 2 follow-up contacts to review any questions/issues participants have. Participants can set additional goals during this time. Over the last 2 months, there will be monthly contacts to address the same issues.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Craig H. Neilsen Foundation

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Ben Mortenson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ben Mortenson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

GF Strong Rehabilitation Center

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 30429114 (View on PubMed)

Other Identifiers

440872

Identifier Type: -

Identifier Source: org_study_id