NCT03764982

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,793

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

November 23, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

2.2 years

First QC Date

November 23, 2018

Last Update Submit

September 29, 2023

Conditions

Keywords

RehabilitationMultidisciplinaryHealth care*the RehabNytte Consortium

Outcome Measures

Primary Outcomes (4)

  • The EuroQoL-5D-5L

    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'.

    1-3 minutes

  • The EuroQoL-VAS health

    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

    1-2 minutes

  • The Patient Specific Functional Scale (PSFS)

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

    2-6 minutes

  • PROMIS 29

    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.

    5-10 minutes

Other Outcomes (1)

  • The MUSS Quality Indicator set for Rehabilitation

    3-8 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Patients receiving rehabilitation at seventeen rehabilitation centres in specialist care (all health regions) * All diagnoses, with largest groups of musculoskeletal diseases, neurological conditions (stroke, MS), cancer, and heart- and lunge conditions.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Helsepartner rehabilitation centre

Alta, Norway

Location

Åstveit rehabilitation centre

Bergen, Norway

Location

Sørlandet rehabilitation centre

Eiken, Norway

Location

Evjeklinikken rehabilitation centre

Evje, Norway

Location

Red Cross Haugland rehabilitation centre

Flekke, Norway

Location

Ravneberghaugen rehabilitation centre

Hagavik, Norway

Location

Hernes institutt

Hernes, Norway

Location

AVONOVA Ringerike rehabilitation centre

Hønefoss, Norway

Location

Røysumtunet rehabiliteringssenter

Jaren, Norway

Location

Selli rehabilitation centre

Klæbu, Norway

Location

HLF Briskeby rehabilitation centre

Lier, Norway

Location

Montebellosenteret

Lillehammer, Norway

Location

Skogli rehabilitation centre

Lillehammer, Norway

Location

NKS Helsehus

Lørenskog, Norway

Location

CatoSenteret

Son, Norway

Location

Muritunet rehabilitation centre

Valldal, Norway

Location

Vikersund rehabilitation centre

Vikersund, Norway

Location

Related Publications (4)

  • Skinnes MN, Uhlig T, Johansen T, Morvik HK, Farsund N, Fossen J, Skardal RF, Tollin G, Degirmenci AET, Habberstad A, Sexton J, Kollerud R, Kjeken I; RehabNytte Consortium; Wilkie R, Moe RH. Exploring differences in health-related benefit status in the year before, during and after specialist rehabilitation: a Norwegian case-control study. BMJ Open. 2026 Jan 21;16(1):e105722. doi: 10.1136/bmjopen-2025-105722.

  • Rimehaug SA, Moe RH, Dagfinrud H, Fischer F, Johansen T, Kjeken I, Klokkerud M, Fossmo HL, Lyken AD, Kvalheim TR, Soldal S, Sand-Svartrud AL; RehabNytte Consortium. Measurement properties of the PROMIS-29 profile v2.1 in a Norwegian rehabilitation context. J Patient Rep Outcomes. 2025 Jul 31;9(1):98. doi: 10.1186/s41687-025-00929-7.

  • Sand-Svartrud AL, Dagfinrud H, Fossen J, Framstad H, Irgens EL, Morvik HK, Sexton J, Moe RH, Kjeken I. Impact of provider feedback on quality improvement in rehabilitation services: an interrupted time series analysis. Front Rehabil Sci. 2025 Mar 6;6:1564346. doi: 10.3389/fresc.2025.1564346. eCollection 2025.

  • Sand-Svartrud AL, Kjeken I, Skardal RF, Gjerset GM, Johnsen TJ, Lyken AD, Dagfinrud H, Moe RH. Completeness of repeated patient-reported outcome measures in adult rehabilitation: a randomized controlled trial in a diverse clinical population. BMC Health Serv Res. 2024 Dec 24;24(1):1648. doi: 10.1186/s12913-024-12103-8.

Study Officials

  • Tore K Kvien, Professor

    Dep.Rheumatology, Diakonhjemmet hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 23, 2018

First Posted

December 5, 2018

Study Start

January 2, 2019

Primary Completion

March 31, 2021

Study Completion

December 31, 2025

Last Updated

October 2, 2023

Record last verified: 2023-09

Locations