- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04540679
Self-Management Across the Care Continuum
An Integrated Self-Management Service Delivery Model for Persons With SCI Across the Care Continuum
Study Overview
Detailed Description
Participants using the e-health solution (called Parkwood VIP4SCI) will have access to features that connect them directly with their clinician(s) such as Virtual calling (initiated by the clinician), Messaging (email) and Scheduling/Calendar features. Platform use will be supported by a "VIP Coach. The clinician, coach and patient participants will also be able to use the e-health solution to create and monitor progress associated with self-management goals and also use embedded educational resources. These resources will also support the patients in best meeting their goals in a timely manner.
User Manuals for both the Client (i.e. Patient) and Provider (i.e. Clinician) are provided and contain screenshots and descriptive text that outline all the features of the intervention.
Patient participants will either be inpatients or outpatients, whereas healthcare team participants will consist of any provider assigned to the patient participant's circle of care at Parkwood Institute. The patient participants can choose to have their caregiver also access the platform - however, due to technical limitations, only 1 account is provided for the patient/caregiver dyad. Health care provider participants will have access to the platform for a specific patient at any time that patient is in the "Platform access" group as described below. The inpatient participants will be randomly allocated to 1 of 2 groups - either 1) "Platform access" or 2) "Standard care" with delayed access to the platform. In the "Standard care" group, the platform will be provided 6 weeks after inpatient discharge with support provided by the VIP coach. Those in the "Platform access" group will receive access within 2 weeks of admission to the inpatient or outpatient team at Parkwood Institute. For those patients transitioning from inpatient to outpatient care, their access to the platform will be guided by which group they were originally assigned to in addition to their needs and discharge circumstances as some of these patients may or may not be picked up by the Parkwood Outpatient team. The criteria influencing this will continue to be guided by the clinical team as per standard care. Participants seen by the outpatient team that were previously enrolled as inpatients in the "Standard care" group will be able to access the platform after 6 weeks of outpatient therapy with VIP coach support only, while those in the "Platform access" group can continue to use the platform with their outpatient health care providers.
Patient participants will complete surveys at specific time points throughout the study including measures at baseline (within 2 weeks of admission), discharge from inpatient program (or 6 weeks from admission for outpatients) and then 6 weeks after that. In the case of the "Standard care" group, there will be an additional follow-up survey to assess outcome measures 6 weeks after they have been provided access to the platform. The outcome measures will assess feasibility, usability, usage analytics and several patient-reported outcomes including self-management-related outcomes, healthcare utilization and prevalence of secondary complications.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dalton Wolfe, PhD
- Phone Number: 42957 519-685-4292
- Email: dwolfe@uwo.ca
Study Contact Backup
- Name: Heather Askes, BSc
- Phone Number: 42940 519-685-4292
- Email: heather.askes@sjhc.london.on.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria - For patient participants:
- >18 years old
- Has a spinal cord injury
- Admitted to SCI inpatients/outpatients at Parkwood Institute for comprehensive Rehabilitation Care (not short stay)
- Has reliable high-speed internet access and device
- Intact cognitive function
Inclusion Criteria - For caregiver participants:
- Have been identified by the patient participant as someone who they would like to participate in a caregiver role
Inclusion Criteria - For health care provider participants:
- Part of the health care team for a patient participant
Exclusion Criteria - For patient participants only:
- <18 years old
- No spinal cord injury
- No access to reliable internet access or device
- Impaired cognitive function
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Inpatient - Standard Care Delayed Platform
Patient will receive standard inpatient care and provided access to the platform 6 weeks after inpatient discharge with support provided by the VIP coach.
|
Technology-enabled self-management & rehabilitation solution
|
Active Comparator: Inpatient - Platform Access
Patient will be provided access to the platform within 2 weeks of admission to the inpatient program
|
Technology-enabled self-management & rehabilitation solution
|
Active Comparator: Outpatient - Platform Access
Patient will be provided access to the platform within 2 weeks of admission to the outpatient program.
If patient is transitioning from the inpatient program, their access to the platform will be guided by which group they were originally assigned to (i.e. if a 6 week delay is applicable).
|
Technology-enabled self-management & rehabilitation solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the use of the platform across 4 sub-domains including a) acceptance, b) demand, c) practicality, and d) limited efficacy
Time Frame: 6 weeks after admission/enrollment (inpatient/outpatient platform access groups), discharge (or 6 weeks after admission if outpatient), and 6 weeks after being provided access to the platform (if Standard Care group)
|
Feasibility will be assessed across 4 subdomains (a) acceptance, b) demand, c) practicality, and d) limited efficacy) by the average scores from a set of 5 point likert-style questions relating to each sub-domain as part of a customized feasibility survey based on the Bowen et al feasibility framework (Am J Prev Med.
2009 May; 36(5): 452-457).
The overall feasibility will be represented by the average score across all of the sub-domains.
|
6 weeks after admission/enrollment (inpatient/outpatient platform access groups), discharge (or 6 weeks after admission if outpatient), and 6 weeks after being provided access to the platform (if Standard Care group)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Roles & Activities - Ability to Participate
Time Frame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
This will be assessed using 4 questions from the Social Roles & Activities - Ability to Participate Short Form 10a which is a subscale in the SCI Quality of Life (SCI-QOL) 1.0 Measurement Tool (Tulsky et al., J Spinal Cord Med.
May, 2015; 38(3): 257-269).
This is a patient-reported outcome measure involving 5-point, likert-based questions.
|
Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
Independence
Time Frame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
This will be assessed using 1 question from the Independence Short Form 8a which is a subscale in the SCI Quality of Life (SCI-QOL) 1.0 Measurement Tool (Tulsky et al., J Spinal Cord Med.
May, 2015; 38(3): 257-269).
This is a patient-reported outcome measure involving 5-point, likert-based questions.
|
Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
Pressure Ulcer
Time Frame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
This will be assessed using 3 questions from the Pressure Ulcers Form 12a which is a subscale in the SCI Quality of Life (SCI-QOL) 1.0 Measurement Tool (Tulsky et al., J Spinal Cord Med.
May, 2015; 38(3): 257-269).
This is a patient-reported outcome measure involving 5-point, likert-based questions.
|
Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
Pain Interference
Time Frame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
This will be assessed using 3 questions from the Pain Interference Form 10a which is a subscale in the SCI Quality of Life (SCI-QOL) 1.0 Measurement Tool (Tulsky et al., J Spinal Cord Med.
May, 2015; 38(3): 257-269).
This is a patient-reported outcome measure involving 5-point, likert-based questions.
|
Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
Pain Behaviour
Time Frame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
This will be assessed using 1 question from the Pain Behaviour Form which is a subscale in the SCI Quality of Life (SCI-QOL) 1.0 Measurement Tool (Tulsky et al., J Spinal Cord Med.
May, 2015; 38(3): 257-269).
This is a patient-reported outcome measure involving 5-point, likert-based questions.
|
Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
Resilience
Time Frame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
This will be assessed using 3 questions from the Resilience Short Form 8a which is a subscale in the SCI Quality of Life (SCI-QOL) 1.0 Measurement Tool (Tulsky et al., J Spinal Cord Med.
May, 2015; 38(3): 257-269).
This is a patient-reported outcome measure involving 5-point, likert-based questions.
|
Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
Impact of Secondary Conditions
Time Frame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
This will be assessed using the Secondary Conditions Scale which involves 4-point, likert-based questions to indicate the degree to which a specific condition is a "problem" (Kalpakjian et al., J Spinal Cord Med.
2007; 30: 62-70).
There are 16 questions, each one addressing a different condition (e.g., bowel dysfunction, bladder dysfunction, diabetes, etc) that are common in persons with spinal cord injury.
|
Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
|
Quality of Mobile Application
Time Frame: 6 weeks after admission/enrollment (inpatient/outpatient platform access groups), discharge (or 6 weeks after admission if outpatient), and 6 weeks after being provided access to the platform (if Standard Care group)
|
This will be assessed using the Mobile Application Rating Scale which is a series of 5-point likert-based questions across 6 sub-domains including (a) engagement, (b) functionality, (c) aesthetics, (d) information quality, (e) subjective quality and (f) perceived impact (Stoyanov et al., JMIR Mhealth Uhealth 2015;3(1):e27).
|
6 weeks after admission/enrollment (inpatient/outpatient platform access groups), discharge (or 6 weeks after admission if outpatient), and 6 weeks after being provided access to the platform (if Standard Care group)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 115501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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