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Clinical Trials/NCT04177459
NCT04177459
Terminated
Not Applicable

Rehabilitation of Adolescents Living With Chronic Fatigue. Health and Quality of Life During the Disease, and How to Remain in School and Spare-time Activities. Testing of a Structured Home-based Rehabilitation Program.

St. Olavs Hospital1 site in 1 country3 target enrollmentDecember 6, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fatigue Syndrome, Chronic
Sponsor
St. Olavs Hospital
Enrollment
3
Locations
1
Primary Endpoint
Health-related quality of life (HRQoL)
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

Previous studies have shown that health-related quality of life (HRQoL) in adolescents living with chronic fatigue syndrome (CFS/ME) is low if compared with healthy adolescents and adolescents living with other chronic diseases. Effective strategies to improve HRQoL in this group are still lacking. Recently we have observed HRQoL in a group of Norwegian adolescents with CFS/ME (not yet published), which is the background for a new study where we have planned an intervention with health promoting dialogues between patient and nurse, as a strategy to improve HRQoL. In this study we have also opened to include adolescents with other chronic fatigue diagnosis with similar challenges in follow-up as in CFS/ME.

Registry
clinicaltrials.gov
Start Date
December 6, 2019
End Date
April 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • chronic fatigue as main symptom (including but not limited to diagnostic codes ICD-10 G93.3 CFS/ME, F48.0 Neurasthenia, R53 Fatigue)
  • having undergone an interdisciplinary diagnostic evaluation at The Children's Clinic or at The Fatigue and CFS/ME Outpatient Clinic, St. Olavs hospital during the period 1.8.2019 - 1.4.
  • being a pupil or wishing to be a pupil.

Exclusion Criteria

  • not Norwegian speaking
  • for any reason unable to read and answer a questionnaire
  • for any reason unable to take part in the health promoting dialogues

Outcomes

Primary Outcomes

Health-related quality of life (HRQoL)

Time Frame: 1 year

assessed by PedsQL Generic Core scale 4.0

Secondary Outcomes

  • EQ-5D-5L(1 year)
  • Mood and Feelings Questionnaire(1 year)
  • Fatigue Questionnaire(1 year)
  • Self-reported follow-up, School functioning and participation in Leisure activities(1 year)

Study Sites (1)

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