RehabNytte- A Study of Rehabilitation Processes in Specialized Care in Norway
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03764982|
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : February 8, 2019
|Condition or disease|
This is a large multicentre cohort study including patients receiving rehabilitation at 17 rehabilitation centre from Norway. 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:
- Patient reported change of function, health and quality of life during the first year after rehabilitation
- Degree of user involvement in rehabilitation
- Quality assessment (use of Quality indicator set)
- Measurement characteristics (feasibility and responsiveness) of recommended PROMS in rehabilitation
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|Official Title:||RehabNytte. Health, Function, Workability and Quality of Life Following Rehabilitation. A Multi Center Study in Specialized Rehabilitation Centers in Norway|
|Actual Study Start Date :||January 2, 2019|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2023|
- 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.
- The MUSS Quality Indicator set for Rehabilitation [ Time Frame: 3-8 minutes ]This Quality Indicator assessment tool consist of two separate questionnaires answered by rehabilitation managers and patients, and each questionnaire consist of 10 and 11 questions respectively. The quality indicators are originally developed for use in Rheumatic and musculoskeletal disorders (RMDs) has been developed and pilot tested according to the Rand/UCLA Appropriateness Method. In this study the set will be tested in a generic population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764982
|Contact: Mari Klokkerud, PhDemail@example.com|
|Contact: Rikke H Moe, PhDfirstname.lastname@example.org|
|Study Director:||Tore K Kvien, Professor||Dep.Rheumatology, Diakonhjemmet hospital|