Spinal Cord InjuriesNCT04540679
Self-Management Across the Care Continuum
A study testing VIP4SCI in people with Spinal Cord Injuries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- VIP4SCI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 29 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- <18 years old
- No spinal cord injury
- No access to reliable internet access or device
- Impaired cognitive function
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Integrated Self-Management Service Delivery Model for Persons With SCI Across the Care Continuum
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- VIP4SCI
- Keywords
- online platform, self-management, e-health, care transitions
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIP4SCIOther
Technology-enabled self-management \& rehabilitation solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: VIP4SCI |
| Inpatient - Platform Access | Active comparator | Patient will be provided access to the platform within 2 weeks of admission to the inpatient program Receives: 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). Receives: Other: VIP4SCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
Independence
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.
Measured: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
Pressure Ulcer
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.
Measured: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
Pain Interference
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.
Measured: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
Pain Behaviour
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.
Measured: Longitudinal measure assessed at baseline and then at discharge (or 6 weeks) and then again 6 weeks later for follow-up
Resilience
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Sep 2020 (estimated)
- Primary completion29 Apr 2021 (estimated)
- Study completion29 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- ForaHealthyMe Inc, University Health Network, Toronto, Spinal Cord Injury Ontario, The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Dalton Wolfe, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Dalton Wolfe, PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540679
- Sponsor's protocol ID
- 115501
- Status last verified
- Sep 2020
- First submitted
- 25 Aug 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Self-Management Service Delivery Model for Persons With SCI Across the Care Continuum
- ClinicalTrials.gov ID
- NCT04540679
- Acronym / sponsor ID
- 115501
- Conditions
- Spinal Cord Injuries
- Keywords
- online platform, self-management, e-health, care transitions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- ForaHealthyMe Inc, University Health Network, Toronto, Spinal Cord Injury Ontario, The Craig H. Neilsen Foundation
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 29 Apr 2021 (estimated)
- Study completion
- 29 Apr 2021 (estimated)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Inpatient - Standard Care Delayed Platform | Active comparator | Other: VIP4SCIPatient will receive standard inpatient care and provided access to the platform 6 weeks after inpatient discharge with support provided by the VIP coach. |
| Inpatient - Platform Access | Active comparator | Other: VIP4SCIPatient will be provided access to the platform within 2 weeks of admission to the inpatient program |
| Outpatient - Platform Access | Active comparator | Other: VIP4SCIPatient 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >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
Key exclusion criteria (4 listed)
- <18 years old
- No spinal cord injury
- No access to reliable internet access or device
- Impaired cognitive function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIP4SCITechnology-enabled self-management \& rehabilitation solution | Other | Inpatient - Platform Access, Inpatient - Standard Care Delayed Platform, Outpatient - Platform Access |
Primary outcome
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.
8 secondary outcomes
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
Independence
Time frame: 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
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
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
Resilience
Time frame: 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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalton Wolfe, PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Questions about this trial
What is this clinical trial studying?
A study testing VIP4SCI in people with Spinal Cord Injuries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalton Wolfe, PhD (519-685-4292 ext. 42957, dwolfe@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.