NCT02800915

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

3.7 years

First QC Date

May 5, 2016

Last Update Submit

January 5, 2022

Conditions

Spinal Cord InjuryPressure Injury

Keywords

Spinal Cord InjuryPressure InjuryHealth Related Quality of LifeTelemedicineService InnovationRehabilitationInterdisciplinary collaborationUser-participationActivity and participationHealth economics

Outcome Measures

Primary Outcomes (3)

  • Health related quality of life

    Measured by the use of SF-36, EQ-5D and SCI QoL BDS

    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

    1 year

  • Cost-utility

    Measured in Euro, by use of QUALYs and ICER in a CE plane

    1 year

Secondary Outcomes (2)

  • Experienced interaction, satisfaction and safety in the follow-up

    1 year

  • Environmental evaluation

    1 year

Study Arms (2)

Intervention, telemedicine and multidisciplinary cooperation

EXPERIMENTAL

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

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.

Other: Service innovation with focus on multidisciplinary collaboration

Interventions

Service innovation with focus on multidisciplinary collaborationOTHER

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

Also known as: Telemedicine in outpatient follow-up
Control, multidisciplinary guidance on request.Intervention, telemedicine and multidisciplinary cooperation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Traumatic or non- traumatic SCI and ongoing pressure injury.
  • Consent to participate.

You may not qualify if:

  • Patients who are unable to give their consent due to cognitive problems.
  • Patients who do not have a permanent/ known address.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnaas Rehabilitation Hospital

Nesoddtangen, Akershus, 1450, Norway

Location

Related Publications (2)

  • 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.

    PMID: 35438645DERIVED

  • 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.

    PMID: 30678710DERIVED

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesPressure UlcerMotor Activity

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Johan K Stanghelle, Prof. MD/PhD

    University of Oslo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD-PRM/ PhD- candidate

Study Record Dates

First Submitted

May 5, 2016

First Posted

June 15, 2016

Study Start

January 1, 2016

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

NO(1)