Improving Self-Management Skills Among People With Spinal Cord Injury (MobileApp)

October 5, 2021 updated by: Ben Mortenson, University of British Columbia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2G9
        • GF Strong Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Immediate Intervention
Participants randomized to this group will receive the intervention, the mobile application ("app"), immediately after baseline data are collected.
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.
OTHER: Delayed intervention
Participants randomized to this group will receive the intervention, the mobile application ("app"), after a three month delay.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
Self-Reported Healthcare Utilization
Time Frame: Throughout the study, up until the end-point (9 months)
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)
Spinal Cord Independence Measure III
Time Frame: At 0 months (baseline)
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)
American Spinal Injury Association Impairment Scale
Time Frame: At 0 months (baseline)
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)
Interpersonal Support Evaluation List (ISEL)
Time Frame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
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
Technology Readiness Index
Time Frame: At 0 months (baseline)
This is a multiple-item scale that measures an individual's readiness to embrace new technologies.
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
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
Health Care Climate Questionnaire
Time Frame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
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
Amount of informal/formal caregiving
Time Frame: At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Craig H. Neilsen Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ben Mortenson, PhD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 440872

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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