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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Norway
    • Akershus
      • Nesoddtangen, Akershus, Norway, 1450
        • Sunnaas Rehabilitation Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention, telemedicine and multidisciplinary cooperation
The intervention group will be offered regular multidisciplinary outpatient follow-up via telemedicine.
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.
Other Names:
  • Telemedicine in outpatient follow-up
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.
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.
Other Names:
  • Telemedicine in outpatient follow-up

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
1 year
Cost-utility
Time Frame: 1 year
Measured in Euro, by use of QUALYs and ICER in a CE plane
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Experienced interaction, satisfaction and safety in the follow-up
Time Frame: 1 year
Measured by use of a custom made Likert scale with 1 being completely dissatisfied and 5 being totally satisfied
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnaas Rehabilitation Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oslo
Karolinska Institutet
Oslo University Hospital
Sahlgrenska University Hospital, Sweden
Haukeland University Hospital
Central Jutland Regional 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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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