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Clinical Trials/NCT03764982
NCT03764982
Active, not recruiting
Not Applicable

RehabNytte - A Multi Center Study in Specialized Rehabilitation Centers in Norway Exploring Health, Function, Workability and Quality of Life Following Rehabilitation

Diakonhjemmet Hospital17 sites in 1 country3,793 target enrollmentJanuary 2, 2019
ConditionsRehabilitation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rehabilitation
Sponsor
Diakonhjemmet Hospital
Enrollment
3793
Locations
17
Primary Endpoint
The EuroQoL-5D-5L
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

The main objective of the study is to describe function and health related to quality of life during the first year after rehabilitation, to measure the degree and impact of user involvement in the rehabilitation process, assess factors associated with change in work -ability and -participation, and to test measurement properties of a new core set of outcome measures for rehabilitation launched by the Norwegian Directorate of Health.

Detailed Description

This is a large multicentre cohort study including patients receiving rehabilitation at 17 rehabilitation centres from Norway, \*the RehabNytte Consortium. Invitation and registration of participants will be conducted by local project coordinators in the period between 01.01.2019 and 31.03.2020. All participants will receive rehabilitation as usual at each centre, and report HRQoL, health and function (by PROMS) through a digital self-reporting system at admission, discharge and after 3, 6 and 12 months. This study seeks to answer several research questions related to the overarching areas: 1. Patient reported change of function, health and quality of life during the first year after rehabilitation 2. Degree of user involvement in rehabilitation 3. Change in work -ability and -participation 4. Quality assessment (use of Quality indicator set) 5. Measurement characteristics (feasibility and responsiveness) of recommended PROMS in rehabilitation

Registry
clinicaltrials.gov
Start Date
January 2, 2019
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Diakonhjemmet Hospital
Responsible Party
Principal Investigator
Principal Investigator

Rikke Helene Moe

Principal Investigator

Diakonhjemmet Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients that participates in inpatient or outpatient rehabilitation programs at one of the participating centers.
  • Age over 18 years
  • Access to internet at home
  • Access to personal secure login with BANK ID.

Exclusion Criteria

  • Severely reduced cognitive function
  • severe mental illness with inadequate consent competence ability to participate
  • Insufficient understanding of Norwegian written language.

Outcomes

Primary Outcomes

The EuroQoL-5D-5L

Time Frame: 1-3 minutes

5-item questionnaire assessing function and health in walking, ADL, personal care, pain/discomfort and anxiety/depression. Sores could be calculated both as numbers and 'utilities'.

The EuroQoL-VAS health

Time Frame: 1-2 minutes

The EUROQUOL 5D-5L includes a 100 mm VAS scale/thermometer. Index value: 0-1, 1 is best VAS gen health: 0-100, 100 is best

The Patient Specific Functional Scale (PSFS)

Time Frame: 2-6 minutes

Patient-specific instrument. Up to five activities are described by the patient, and scored according to experienced performance (0-10, 10 is best).

PROMIS 29

Time Frame: 5-10 minutes

The PROMIS-29, a generic health-related quality of life survey, assesses each of the 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities) with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity.

Study Sites (17)

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