Spinal Cord InjuriesMobileAppNCT03140501
Improving Self-Management Skills Among People With Spinal Cord Injury
A study testing Mobile application ("app") in people with Spinal Cord Injuries and Self-Management, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Self-Management, Mobile Application
- What is being tested?
- Mobile application ("app")
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2018to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
GF Strong Rehabilitation Center
Vancouver, British Columbia, V5Z 2G9
About this study
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.
Read the 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
- Being tested
- Mobile application ("app")
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application ("app")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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Participants randomized to this group will receive the intervention, the mobile application ("app"), immediately after baseline data are collected. Receives: Device: Mobile application ("app") |
| Delayed intervention | Other | Participants randomized to this group will receive the intervention, the mobile application ("app"), after a three month delay. Receives: Device: Mobile application ("app") |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Secondary outcomes (10)
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.
Measured: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
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.
Measured: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
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.
Measured: Throughout the study, up until the end-point (9 months)
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.
Measured: At 0 months (baseline)
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.
Measured: At 0 months (baseline)
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.
Measured: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Technology Readiness Index
This is a multiple-item scale that measures an individual's readiness to embrace new technologies.
Measured: At 0 months (baseline)
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.
Measured: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
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.
Measured: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Amount of informal/formal caregiving
This measure is used to determine the amount of caregiving that participants require from their formal and informal caregivers
Measured: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start8 Jan 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Ben Mortenson, University of British Columbia
- Investigators
- Ben Mortenson, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140501
- Sponsor's protocol ID
- 440872
- Acronym
- MobileApp
- Status last verified
- Oct 2021
- First submitted
- 26 Apr 2017
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30429114
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Self-Management Skills Among People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03140501
- Acronym / sponsor ID
- MobileApp / 440872
- Conditions
- Spinal Cord Injuries, Self-Management, Mobile Application
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Device: Mobile application ("app")Participants randomized to this group will receive the intervention, the mobile application ("app"), immediately after baseline data are collected. |
| Delayed intervention | Other | Device: Mobile application ("app")Participants randomized to this group will receive the intervention, the mobile application ("app"), after a three month delay. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Delayed intervention, Immediate Intervention |
Primary outcome
Goal Attainment Scaling (GAS)
Time frame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
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.
10 secondary outcomes
Self-Efficacy for Managing Chronic Disease Scale
Time frame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Spinal Cord Injury Secondary Conditions Scale
Time frame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Self-Reported Healthcare Utilization
Time frame: Throughout the study, up until the end-point (9 months)
Spinal Cord Independence Measure III
Time frame: At 0 months (baseline)
American Spinal Injury Association Impairment Scale
Time frame: At 0 months (baseline)
Interpersonal Support Evaluation List (ISEL)
Time frame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Technology Readiness Index
Time frame: At 0 months (baseline)
Leisure Time Physical Activity Questionnaire-SCI
Time frame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Health Care Climate Questionnaire
Time frame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Amount of informal/formal caregiving
Time frame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Derived from this study: PubMed 30429114Mortenson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Mortenson, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application ("app") in people with Spinal Cord Injuries and Self-Management, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scaling (GAS) (time frame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03140501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.