Telemedicine Makes the Patient Stay in Hospital at Home

NCT ID: NCT02800915

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury Pressure Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention, telemedicine and multidisciplinary cooperation

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

Group Type EXPERIMENTAL

Service innovation with focus on multidisciplinary collaboration

Intervention Type OTHER

The follow-up is performed via telemedicine (videoconference) to the patient in his or her own home, and in cooperation with the district nurses.

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.

Group Type ACTIVE_COMPARATOR

Service innovation with focus on multidisciplinary collaboration

Intervention Type OTHER

The follow-up is performed via telemedicine (videoconference) to the patient in his or her own home, and in cooperation with the district nurses.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Telemedicine in outpatient follow-up

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Haukeland University Hospital

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Central Jutland Regional Hospital

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

University Hospital of Trondheim, Norway

UNKNOWN

Sponsor Role collaborator

Oslo Centre for Biostatistics and Epidemiology, Norway

UNKNOWN

Sponsor Role collaborator

Norwegian Centre for Integrated Care and Telemedicine (NST), Norway

UNKNOWN

Sponsor Role collaborator

Institute of Clinical Medicine, Rigshospitalet, Denmark

UNKNOWN

Sponsor Role collaborator

Birmingham VA Medical Center/University of Alabama School of Medicine, USA

UNKNOWN

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Sunnaas Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ingebjørg Irgens

MD-PRM/ PhD- candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Johan K Stanghelle, Prof. MD/PhD

Role: STUDY_DIRECTOR

University of Oslo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sunnaas Rehabilitation Hospital

Nesoddtangen, Akershus, Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35438645 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30678710 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://doi.org/10.1038/s41393-020-0465-z

Pressure injury occurence in people with a newly aqcuired spinal cord injury in acute care rehabilitation

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014/684

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Living With Spinal Cord Injury.
NCT03709732 COMPLETED