Self-Management Across the Care Continuum

NCT04540679 | Unknown

• 1 other identifier: 115501
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injuries

Keywords

online platform; self-management; e-health; care transitions

Outcome Measures

Primary Outcomes (1)

• Feasibility of the use of the platform across 4 sub-domains including a) acceptance, b) demand, c) practicality, and d) limited efficacy

  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 Outcomes (8)

• Social Roles & Activities - Ability to Participate

  Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up

• Independence

  Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up

• Pressure Ulcer

  Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up

• Pain Interference

  Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up

• Pain Behaviour

  Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up

Study Arms (3)

Inpatient - Standard Care Delayed Platform

ACTIVE COMPARATOR

Patient will receive standard inpatient care and provided access to the platform 6 weeks after inpatient discharge with support provided by the VIP coach.

Other: VIP4SCI

Inpatient - Platform Access

ACTIVE COMPARATOR

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

Other: VIP4SCI

Outpatient - Platform Access

ACTIVE COMPARATOR

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).

Other: VIP4SCI

Interventions

VIP4SCI OTHER

Technology-enabled self-management \& rehabilitation solution

Inpatient - Platform Access; Inpatient - Standard Care Delayed Platform; Outpatient - Platform Access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• \<18 years old
• No spinal cord injury
• No access to reliable internet access or device
• Impaired cognitive function

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• ForaHealthyMe Inc: collaborator
• University Health Network, Toronto: collaborator
• Spinal Cord Injury Ontario: collaborator
• The Craig H. Neilsen Foundation: collaborator

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Dalton Wolfe, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalton Wolfe, PhD

CONTACT

519-685-4292; dwolfe@uwo.ca

Heather Askes, BSc

CONTACT

519-685-4292; heather.askes@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: 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

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 7, 2020
• Study Start: September 1, 2020
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: September 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share