Improving Self-Management Skills Among People With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

— MobileApp  

Official title:

Improving Self-Management Skills Among People With Spinal Cord Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03140501
• Other study ID #: 440872
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: December 2022

Study information

• Verified date: October 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mobile Application
• Self-Management
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	GF Strong Rehabilitation Center	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	The Craig H. Neilsen Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Goal Attainment Scaling (GAS)	GAS is a promising approach for evaluating psychosocial interventions in community settings. This measure will be used to identify self-management goals that participants want to achieve. Objective outcomes are identified that indicate degrees of attainment of participant-selected goals on a five-point scale ranging from -2 to +2, where -2 is a much worse than expected outcome, 0 represents attaining the goal (the anticipated outcome) and 2 means a much better than expected outcome, and then aggregate T-scores are calculated. The minimally clinically important change for GAS is 10, based on the linear T-score, which represents a change in score from the anticipated values.	At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Secondary	Self-Efficacy for Managing Chronic Disease Scale	This scale is designed to evaluate confidence in managing long-term disease. It has been used extensively in many different populations including people with spinal cord injury to evaluate self-management interventions. Each of the 6-items are rated on a scale of 1-10 (with 1 indicating 'not at all confident' and 10 indicating 'totally confident') and an average score is calculated.	At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Secondary	Spinal Cord Injury Secondary Conditions Scale	This is one of two outcome measures that assesses self-efficacy. This scale targets secondary conditions related to spinal cord injury that have both direct and indirect impacts on health. The 16-item scale uses a 4-point ordinal scale ranging from 'no problem' to 'significant problem' with the total score ranging from 0-49.	At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Secondary	Self-Reported Healthcare Utilization	Healthcare utilization will be measured by having participants record visits to see a physician, visits to hospital emergency departments, number of hospitalizations, and the number of nights spent in hospital. Although there may be recall issues within self-reported healthcare utilization, it has been found to be highly correlated with days in hospital (r=0.83) (17). Participants will complete a weekly journal to help improve the accuracy of the report.	Throughout the study, up until the end-point (9 months)
Secondary	Spinal Cord Independence Measure III	This is a disability scale developed to specifically address the ability of spinal cord injury patients to perform basic activities of daily living independently. It assesses three areas: 1) self-care (e.g., feeding, grooming, bathing, and dressing), 2) respiration and sphincter management, and 3) mobility (bed and transfers and indoor/outdoor). The item scores are weighted related to the assumed clinical relevance.	At 0 months (baseline)
Secondary	American Spinal Injury Association Impairment Scale	This is a clinical examination conducted to test whether sensation is 0-absent; 1-impaired; or 2-normal. Muscle function is rated from 0-total paralysis to 5-normal (active movement, full range of motion against significant resistance). Although the investigators will be unable to administer the measure as it requires significant and specialized training, a research team member will ask participants if they have been evaluated and what their motor and sensory impairment level is, if they know. This is included in the demographics form.	At 0 months (baseline)
Secondary	Interpersonal Support Evaluation List (ISEL)	This list measures the perceptions of social support among individuals in the general population. It examines the ways in which others affect persons' responses to stressful events. It consists of a list of 40 statements concerning the perceived availability of potential social resources. The items are counterbalanced for desirability - half the items are positive statements about social relationships while the other half are negative statements. Items fall into four 10-item sub-scales: tangible support, appraisal support, self-esteem support, belonging support.	At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Secondary	Technology Readiness Index	This is a multiple-item scale that measures an individual's readiness to embrace new technologies.	At 0 months (baseline)
Secondary	Leisure Time Physical Activity Questionnaire-SCI	This is an SCI-specific, self-report measure of leisure time physical activity (LTPA) that assesses minutes of mild, moderate, and heavy intensity LTPA performed over the previous 7 days. It is unique because it captures different types of LTPA performed at different intensities.	At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Secondary	Health Care Climate Questionnaire	This measure is used to access patients' perceptions of the degree to which their specific doctor is autonomy supportive, and it can be used to assess patients' perceptions of the degree to which their team of health care providers is autonomy supportive.	At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Secondary	Amount of informal/formal caregiving	This measure is used to determine the amount of caregiving that participants require from their formal and informal caregivers	At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline