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Trial record 1 of 1 for:    nct02800915
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Telemedicine Makes the Patient Stay in Hospital at Home (TeleSCIpu)

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ClinicalTrials.gov Identifier: NCT02800915
Recruitment Status : Enrolling by invitation
First Posted : June 15, 2016
Last Update Posted : October 9, 2017
Sponsor:
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
Information provided by (Responsible Party):
Ingebjørg Irgens, Sunnaas Rehabilitation Hospital

Brief Summary:
The goal of the project is to study whether interdisciplinary follow- up performed via telemedicine to the patient in his or her own home, will improve the quality of the healthcare services offered to a particular group of patients. The investigators believe this could increase knowledge and expertise, give significant socioeconomic benefits, and allow greater accessibility to specialized healthcare services, as well as increase the user-involvement for patients and those working in primary healthcare.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Pressure Ulcer Other: Service innovation with focus on interdisciplinary collaboration Not Applicable

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 ulcers are considerable. In addition to direct treatment- related costs, pressure ulcers also impact the hospital performance metrics. On top of the financial implications, pressure ulcers 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 prevention of pressure ulcers. An interdisciplinary approach, including home-based rehabilitation programs, might help prevent PUs and their complications, and thus reduce associated costs. The investigators conducted a pilot in 2012, in which patients with SCI and PU were monitored through interdisciplinary outpatient homecare, using telemedicine. The project was beneficial for the users/ patients, especially in terms of user- participation and -contribution, the improved quality of life, and a better cooperation between primary and specialized healthcare services. 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 this study can be made available to most PU patients. Knowledge about PU will contribute in both planning and establishment of good treatment lines for the patients, as well as contribute to environmental savings and a 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telemedicine Makes the Patient Stay in Hospital at Home. Service Innovation With Focus on Interdisciplinary Collaboration
Study Start Date : June 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention, telemedicine and interdisciplinary cooperation
The intervention group will be offered regular interdisciplinary outpatient follow-up via telemedicine.
Other: Service innovation with focus on interdisciplinary collaboration
The follow- up is performed via telemedicine to the patient in his or her own home, and in cooperation with the local health care workers.
Other Name: Telemedicine in outpatient follow- up

Active Comparator: Control, interdisciplinary guidance on request.
The control group will receive guidance based on existing routines, and based on initiative taken by the local healthcare service/ patient/ next of kin.
Other: Service innovation with focus on interdisciplinary collaboration
The follow- up is performed via telemedicine to the patient in his or her own home, and in cooperation with the local health care workers.
Other Name: Telemedicine in outpatient follow- up




Primary Outcome Measures :
  1. Health related quality of life [ Time Frame: 2 year ]
    Measured by the use of SF-36


Secondary Outcome Measures :
  1. Wound healing [ Time Frame: 2 years ]
    The reduction of pressure ulcer size will be measured in percentage

  2. Cost- benefit [ Time Frame: 2 year ]
    Measured in Norwegian Kroner (NOK)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Traumatic or non- traumatic SCI and ongoing pressure ulcer.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800915


Locations
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Norway
Sunnaas Rehabilitation Hospital
Nesoddtangen, Akershus, Norway, 1450
Sponsors and Collaborators
Sunnaas Rehabilitation Hospital
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
Investigators
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Study Director: Johan K Stanghelle, Prof.MD/PhD Sunnaas Rehabilitation Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ingebjørg Irgens, MD-PRM/ PhD- candidate, Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02800915     History of Changes
Other Study ID Numbers: 2014/684
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017

Keywords provided by Ingebjørg Irgens, Sunnaas Rehabilitation Hospital:
Spinal Cord Injury
Pressure Ulcer
Health Related Quality of Life
Telemedicine
Service Innovation
Rehabilitation
Interdisciplinary collaboration
User- participation
Activity and participation
Health economics

Additional relevant MeSH terms:
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Spinal Cord Injuries
Pressure Ulcer
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Skin Ulcer
Skin Diseases