Clinical trial NCT04540679: Self-Management Across the Care Continuum
Official title: An Integrated Self-Management Service Delivery Model for Persons With SCI Across the Care Continuum
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: online platform
self-management
e-health
care transitions
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: ForaHealthyMe Inc
name: University Health Network, Toronto
name: Spinal Cord Injury Ontario
name: The Craig H. Neilsen Foundation
First posted: 2020-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective experimental trial with two sets of participants a) Inpatients being randomized to one of two groups with pre-post assessments and b) outpatients being non-randomized with pre-post assessments
Primary purpose: OTHER

Brief summary: Persons with spinal cord injury (SCI) face many challenges as they transition from inpatient care to outpatients and on into the community. With shorter lengths of stay and barriers to coordinating care between SCI specialists and community service providers, the development of self-management skills are an integral part in the effective community reintegration, proper healthcare utilization, management of secondary complications as well as independence and community participation. Based on the best available behaviour change theory, this initiative utilizes an online e-health Platform as a key component of a novel care service delivery model to enhance the development of effective self-management skills. This Platform will be provided to participants receiving care in the inpatient or outpatient programs at Parkwood Institute with the potential to continue its use in the community. Participants will complete surveys prior to, during and following use of the e-health solution. These will assess feasibility, usability, usage analytics and several patient-reported outcomes including self-management-related outcomes, healthcare utilization and prevalence of secondary complications. This platform is especially relevant to our current state of dealing with COVID-19 and the challenges it presents for clinicians and their patients in that it will provide an online solution during a time of physical isolation as well as providing access to tools and resources as people transition back to their home communities following specialized rehabilitation services.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the use of the platform across 4 sub-domains including a) acceptance, b) demand, c) practicality, and d) limited efficacy
timeFrame: 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 outcomes:
measure: Social Roles & Activities - Ability to Participate
timeFrame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
measure: Independence
timeFrame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
measure: Pressure Ulcer
timeFrame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
measure: Pain Interference
timeFrame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
measure: Pain Behaviour
timeFrame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
measure: Resilience
timeFrame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
measure: Impact of Secondary Conditions
timeFrame: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
measure: Quality of Mobile Application
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Dalton Wolfe, PhD
role: PRINCIPAL_INVESTIGATOR
References: