Spinal Cord InjuryTeleSCIpiNCT02800915
Telemedicine Makes the Patient Stay in Hospital at Home
A study testing Service innovation with focus on multidisciplinary collaboration in people with Spinal Cord Injury and Pressure Injury, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Pressure Injury
- What is being tested?
- Service innovation with focus on multidisciplinary collaboration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2016to 31 Aug 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic or non- traumatic SCI and ongoing pressure injury.
- Consent to participate.
Who cannot join
- Patients who are unable to give their consent due to cognitive problems.
- Patients who do not have a permanent/ known address.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injury, Pressure Injury
- Being tested
- Service innovation with focus on multidisciplinary collaboration
- Keywords
- Spinal Cord Injury, Pressure Injury, Health Related Quality of Life, Telemedicine, Service Innovation, Rehabilitation, Interdisciplinary collaboration, User-participation, Activity and participation, Health economics
- Medical subject headings
- Spinal Cord Injuries, Pressure Ulcer, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Service innovation with focus on multidisciplinary collaborationOther
Also called Telemedicine in outpatient follow-up
The follow-up is performed via telemedicine (videoconference) to the patient in his or her own home, and in cooperation with the district nurses.
| Study group | Role | What they receive |
|---|---|---|
| Intervention, telemedicine and multidisciplinary cooperation | Experimental | The intervention group will be offered regular multidisciplinary outpatient follow-up via telemedicine. Receives: Other: Service innovation with focus on multidisciplinary collaboration |
| Control, multidisciplinary guidance on request. | Active comparator | 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. Receives: Other: Service innovation with focus on multidisciplinary collaboration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Measured by the use of SF-36, EQ-5D and SCI QoL BDS
Measured: 1 year
Wound healing
The reduction of pressure injury size will be measured in percentage and time to healing as days from baseline to healing
Measured: 1 year
Cost-utility
Measured in Euro, by use of QUALYs and ICER in a CE plane
Measured: 1 year
Secondary outcomes (2)
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
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start1 Jan 2016
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, University of Oslo, Central Jutland Regional Hospital, Sahlgrenska University Hospital, Oslo University Hospital, St. Olavs Hospital, Oslo Centre for Biostatistics and Epidemiology, Norway, Norwegian Centre for Integrated Care and Telemedicine, Copenhagen University Hospital, Rigshospitalet, University of Alabama at Birmingham, Karolinska Institutet
- Responsible party
- Principal investigator, Ingebjørg Irgens, Sunnaas Rehabilitation Hospital
- Investigators
- Johan K Stanghelle, Prof. MD/PhD, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800915
- Sponsor's protocol ID
- 2014/684
- Acronym
- TeleSCIpi
- Status last verified
- Jan 2022
- First submitted
- 5 May 2016
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Irgens I, Kleven L, Midelfart-Hoff J, Jelnes R, Alexander M, Stanghelle JK, Rekand T. Cost-utility analysis and impact on the environment of videoconference in pressure injury. A randomized controlled trial in individuals with spinal cord injury. Spinal Cord Ser Cases. 2024 Mar 8;10(1):10. doi: 10.1038/s41394-024-00621-w.
PubMed 38459049Irgens 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.
PubMed 35438645Irgens 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.
PubMed 30678710
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Makes the Patient Stay in Hospital at Home. Service Innovation With Focus on Multidisciplinary Collaboration
- ClinicalTrials.gov ID
- NCT02800915
- Acronym / sponsor ID
- TeleSCIpi / 2014/684
- Conditions
- Spinal Cord Injury, Pressure Injury
- Keywords
- Spinal Cord Injury, Pressure Injury, Health Related Quality of Life, Telemedicine, Service Innovation, Rehabilitation, Interdisciplinary collaboration, User-participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, University of Oslo, Central Jutland Regional Hospital, Sahlgrenska University Hospital, Oslo University Hospital, St. Olavs Hospital, Oslo Centre for Biostatistics and Epidemiology, Norway, Norwegian Centre for Integrated Care and Telemedicine, Copenhagen University Hospital, Rigshospitalet, University of Alabama at Birmingham, Karolinska Institutet
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 15 Jun 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention, telemedicine and multidisciplinary cooperation | Experimental | Other: Service innovation with focus on multidisciplinary collaborationThe intervention group will be offered regular multidisciplinary outpatient follow-up via telemedicine. |
| Control, multidisciplinary guidance on request. | Active comparator | Other: Service innovation with focus on multidisciplinary collaborationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Traumatic or non- traumatic SCI and ongoing pressure injury.
- Consent to participate.
Key exclusion criteria (2 listed)
- Patients who are unable to give their consent due to cognitive problems.
- Patients who do not have a permanent/ known address.
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 |
|---|---|---|
| Service innovation with focus on multidisciplinary collaborationAlso: Telemedicine in outpatient follow-upThe follow-up is performed via telemedicine (videoconference) to the patient in his or her own home, and in cooperation with the district nurses. | Other | Control, multidisciplinary guidance on request., Intervention, telemedicine and multidisciplinary cooperation |
Primary outcome
Health related quality of life
Time frame: 1 year
Measured by the use of SF-36, EQ-5D and SCI QoL BDS
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
Cost-utility
Time frame: 1 year
Measured in Euro, by use of QUALYs and ICER in a CE plane
2 secondary outcomes
Experienced interaction, satisfaction and safety in the follow-up
Time frame: 1 year
Environmental evaluation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Derived from this study: PubMed 38459049Irgens I, Kleven L, Midelfart-Hoff J, Jelnes R, Alexander M, Stanghelle JK, Rekand T. Cost-utility analysis and impact on the environment of videoconference in pressure injury. A randomized controlled trial in individuals with spinal cord injury. Spinal Cord Ser Cases. 2024 Mar 8;10(1):10. doi: 10.1038/s41394-024-00621-w.
- Derived from this study: PubMed 35438645Irgens 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.
- Derived from this study: PubMed 30678710Irgens 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.
- Protocol of the studyLink provided by the sponsor.
- Pressure injury occurence in people with a newly aqcuired spinal cord injury in acute care rehabilitationLink provided by the sponsor.
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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.
Johan K Stanghelle, Prof. MD/PhD study director
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Service innovation with focus on multidisciplinary collaboration in people with Spinal Cord Injury and Pressure Injury, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800915, which also lists 3 linked publications.
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 21 Jan 2022.