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Telemedicine Makes the Patient Stay in Hospital at Home (TeleSCIpi)

Primary Purpose

Spinal Cord Injury, Pressure Injury

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Service innovation with focus on multidisciplinary collaboration
Sponsored by
Sunnaas Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, Pressure Injury, Health Related Quality of Life, Telemedicine, Service Innovation, Rehabilitation, Interdisciplinary collaboration, User-participation, Activity and participation, Health economics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sunnaas Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention, telemedicine and multidisciplinary cooperation

Control, multidisciplinary guidance on request.

Arm Description

The intervention group will be offered regular multidisciplinary outpatient follow-up via telemedicine.

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.

Outcomes

Primary Outcome Measures

Health related quality of life
Measured by the use of SF-36, EQ-5D and SCI QoL BDS
Wound healing
The reduction of pressure injury size will be measured in percentage and time to healing as days from baseline to healing
Cost-utility
Measured in Euro, by use of QUALYs and ICER in a CE plane

Secondary Outcome Measures

Experienced interaction, satisfaction and safety in the follow-up
Measured by use of a custom made Likert scale with 1 being completely dissatisfied and 5 being totally satisfied
Environmental evaluation
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

Full Information

First Posted
May 5, 2016
Last Updated
January 5, 2022
Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
Haukeland University Hospital, University of Oslo, Central Jutland Regional Hospital, Sahlgrenska University Hospital, Sweden, Oslo University Hospital, University Hospital of Trondheim, Norway, Oslo Centre for Biostatistics and Epidemiology, Norway, Norwegian Centre for Integrated Care and Telemedicine (NST), Norway, Institute of Clinical Medicine, Rigshospitalet, Denmark, Birmingham VA Medical Center/University of Alabama School of Medicine, USA, Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02800915
Brief Title
Telemedicine Makes the Patient Stay in Hospital at Home
Acronym
TeleSCIpi
Official Title
Telemedicine Makes the Patient Stay in Hospital at Home. Service Innovation With Focus on Multidisciplinary Collaboration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
Haukeland University Hospital, University of Oslo, Central Jutland Regional Hospital, Sahlgrenska University Hospital, Sweden, Oslo University Hospital, University Hospital of Trondheim, Norway, Oslo Centre for Biostatistics and Epidemiology, Norway, Norwegian Centre for Integrated Care and Telemedicine (NST), Norway, Institute of Clinical Medicine, Rigshospitalet, Denmark, Birmingham VA Medical Center/University of Alabama School of Medicine, USA, Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Pressure Injury
Keywords
Spinal Cord Injury, Pressure Injury, Health Related Quality of Life, Telemedicine, Service Innovation, Rehabilitation, Interdisciplinary collaboration, User-participation, Activity and participation, Health economics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention, telemedicine and multidisciplinary cooperation
Arm Type
Experimental
Arm Description
The intervention group will be offered regular multidisciplinary outpatient follow-up via telemedicine.
Arm Title
Control, multidisciplinary guidance on request.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Service innovation with focus on multidisciplinary collaboration
Other Intervention Name(s)
Telemedicine in outpatient follow-up
Intervention Description
The follow-up is performed via telemedicine (videoconference) to the patient in his or her own home, and in cooperation with the district nurses.
Primary Outcome Measure Information:
Title
Health related quality of life
Description
Measured by the use of SF-36, EQ-5D and SCI QoL BDS
Time Frame
1 year
Title
Wound healing
Description
The reduction of pressure injury size will be measured in percentage and time to healing as days from baseline to healing
Time Frame
1 year
Title
Cost-utility
Description
Measured in Euro, by use of QUALYs and ICER in a CE plane
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Experienced interaction, satisfaction and safety in the follow-up
Description
Measured by use of a custom made Likert scale with 1 being completely dissatisfied and 5 being totally satisfied
Time Frame
1 year
Title
Environmental evaluation
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan K Stanghelle, Prof. MD/PhD
Organizational Affiliation
University of Oslo
Official's Role
Study Director
Facility Information:
Facility Name
Sunnaas Rehabilitation Hospital
City
Nesoddtangen
State/Province
Akershus
ZIP/Postal Code
1450
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
35438645
Citation
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.
Results Reference
derived
PubMed Identifier
30678710
Citation
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.
Results Reference
derived
Links:
URL
http://doi.org/10.1186/s13063-019-3185-y
Description
Protocol of the study
URL
http://doi.org/10.1038/s41393-020-0465-z
Description
Pressure injury occurence in people with a newly aqcuired spinal cord injury in acute care rehabilitation

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Telemedicine Makes the Patient Stay in Hospital at Home

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