Self-Management Across the Care Continuum

NCT ID: NCT04540679

Last Updated: 2020-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-04-29

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

VIP4SCI

Intervention Type OTHER

Technology-enabled self-management \& rehabilitation solution

Inpatient - Platform Access

Patient will be provided access to the platform within 2 weeks of admission to the inpatient program

Group Type ACTIVE_COMPARATOR

VIP4SCI

Intervention Type OTHER

Technology-enabled self-management \& rehabilitation solution

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).

Group Type ACTIVE_COMPARATOR

VIP4SCI

Intervention Type OTHER

Technology-enabled self-management \& rehabilitation solution

Interventions

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VIP4SCI

Technology-enabled self-management \& rehabilitation solution

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \>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


\- Have been identified by the patient participant as someone who they would like to participate in a caregiver role


\- Part of the health care team for a patient participant

Exclusion Criteria

* \<18 years old
* No spinal cord injury
* No access to reliable internet access or device
* Impaired cognitive function
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ForaHealthyMe Inc

UNKNOWN

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role collaborator

Spinal Cord Injury Ontario

UNKNOWN

Sponsor Role collaborator

The Craig H. Neilsen Foundation

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Dalton Wolfe

Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalton Wolfe, PhD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Central Contacts

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Dalton Wolfe, PhD

Role: CONTACT

519-685-4292 ext. 42957

Heather Askes, BSc

Role: CONTACT

519-685-4292 ext. 42940

Other Identifiers

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115501

Identifier Type: -

Identifier Source: org_study_id

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