- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02800915
Telemedicine Makes the Patient Stay in Hospital at Home (TeleSCIpi)
January 5, 2022 updated by: Ingebjørg Irgens, Sunnaas Rehabilitation Hospital
Telemedicine Makes the Patient Stay in Hospital at Home. Service Innovation With Focus on Multidisciplinary Collaboration
The goal of the project is to study whether multidisciplinary follow- up performed via telemedicine to the patient in his or her own home, will improve the healthcare services offered to a particular group of patients.
The hypotheses are that this could increase the treatment options, increase knowledge translation, give significant socioeconomic benefits, and allow greater accessibility to specialized healthcare services, as well as increase the involvement of patients and those working in primary healthcare.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The goals of rehabilitation are to improve functional level, decrease secondary morbidity and enhance health-related quality of life.
The costs associated with pressure injury are considerable.
In addition to direct treatment- related costs, pressure injury also impact the hospital performance metrics.
On top of the financial implications, pressure injury have a significant impact on patient morbidity and -mortality, as well as on health related quality of life.
The researchers believe there is a large potential for improvement in treatment of pressure injuries.
An multidisciplinary approach, including home-based rehabilitation programs, might help prevent pressure injuries and their complications, and thus reduce associated costs.
The investigators conducted a pilot in 2012, in which patients with spinal cord injury and pressure injury were monitored through multidisciplinary outpatient home care, using telemedicine.
The project was beneficial for the consumers/ patients, especially in terms of consumer- participation and -contribution, improved quality of life, and a better cooperation between primary and specialized healthcare services.
Retrospective economic analysis indicated that telemedicine provides great savings for public healthcare services, and that using telemedicine with other patient groups with similar problems, could be beneficial.
A positive outcome of the current study can be made available to most people with pressure injury.
Knowledge about pressure injury will contribute in both planning and establishment of good treatment lines for the patients, as well as contribute to environmental savings, and more proper use of the health resources.
This may reduce the consumption of hospital services, because a larger proportion of services are provided by the municipality.
An important scientific significance of this research will thus be to improve, simplify and streamline health care and health- related services.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Akershus
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Nesoddtangen, Akershus, Norway, 1450
- Sunnaas rehabilitation hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Traumatic or non- traumatic SCI and ongoing pressure injury.
- Consent to participate.
Exclusion Criteria:
- Patients who are unable to give their consent due to cognitive problems.
- Patients who do not have a permanent/ known address.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention, telemedicine and multidisciplinary cooperation
The intervention group will be offered regular multidisciplinary outpatient follow-up via telemedicine.
|
The follow-up is performed via telemedicine (videoconference) to the patient in his or her own home, and in cooperation with the district nurses.
Other Names:
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Active Comparator: Control, multidisciplinary guidance on request.
The control group will receive guidance based on existing routines (on-site consultations at the wound clinic and telephone consultations), and based on initiative taken by the local healthcare service/ patient/ next of kin.
|
The follow-up is performed via telemedicine (videoconference) to the patient in his or her own home, and in cooperation with the district nurses.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life
Time Frame: 1 year
|
Measured by the use of SF-36, EQ-5D and SCI QoL BDS
|
1 year
|
Wound healing
Time Frame: 1 year
|
The reduction of pressure injury size will be measured in percentage and time to healing as days from baseline to healing
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1 year
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Cost-utility
Time Frame: 1 year
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Measured in Euro, by use of QUALYs and ICER in a CE plane
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experienced interaction, satisfaction and safety in the follow-up
Time Frame: 1 year
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Measured by use of a custom made Likert scale with 1 being completely dissatisfied and 5 being totally satisfied
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1 year
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Environmental evaluation
Time Frame: 1 year
|
Measured in terms of travel distance, travel time used and travel costs by use of The Michelin Travel's Route Planner.
Environmental emission due to the travel will be measured in terms of Carbon Oxide values, called CO2 equivalents
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1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Johan K Stanghelle, Prof. MD/PhD, University of Oslo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Irgens I, Midelfart-Hoff J, Jelnes R, Alexander M, Stanghelle JK, Thoresen M, Rekand T. Videoconferencing in Pressure Injury: Randomized Controlled Telemedicine Trial in Patients With Spinal Cord Injury. JMIR Form Res. 2022 Apr 19;6(4):e27692. doi: 10.2196/27692.
- Irgens I, Hoff JM, Sorli H, Haugland H, Stanghelle JK, Rekand T. Hospital based care at home; study protocol for a mixed epidemiological and randomized controlled trial. Trials. 2019 Jan 24;20(1):77. doi: 10.1186/s13063-019-3185-y.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
August 31, 2019
Study Completion (Actual)
August 31, 2019
Study Registration Dates
First Submitted
May 5, 2016
First Submitted That Met QC Criteria
June 12, 2016
First Posted (Estimate)
June 15, 2016
Study Record Updates
Last Update Posted (Actual)
January 21, 2022
Last Update Submitted That Met QC Criteria
January 5, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/684
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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