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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02800915
Other study ID # 2014/684
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date August 31, 2019

Study information

Verified date January 2022
Source Sunnaas Rehabilitation Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Service innovation with focus on multidisciplinary collaboration
The follow-up is performed via telemedicine (videoconference) to the patient in his or her own home, and in cooperation with the district nurses.

Locations

Country Name City State
Norway Sunnaas Rehabilitation Hospital Nesoddtangen Akershus

Sponsors (12)

Lead Sponsor Collaborator
Sunnaas Rehabilitation Hospital Birmingham VA Medical Center/University of Alabama School of Medicine, USA, Central Jutland Regional Hospital, Haukeland University Hospital, Institute of Clinical Medicine, Rigshospitalet, Denmark, Karolinska Institutet, Norwegian Centre for Integrated Care and Telemedicine (NST), Norway, Oslo Centre for Biostatistics and Epidemiology, Norway, Oslo University Hospital, Sahlgrenska University Hospital, Sweden, University Hospital of Trondheim, Norway, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health related quality of life Measured by the use of SF-36, EQ-5D and SCI QoL BDS 1 year
Primary Wound healing The reduction of pressure injury size will be measured in percentage and time to healing as days from baseline to healing 1 year
Primary Cost-utility Measured in Euro, by use of QUALYs and ICER in a CE plane 1 year
Secondary 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 1 year
Secondary 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 1 year
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