Rehabilitation of Adolescents Living With Chronic Fatigue

Not Applicable

Terminated

• Conditions: Fatigue Syndrome, Chronic

• Registration Number: NCT04177459
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-26
• Study Start: 2019-12-06
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 - 1.4.2020.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health-related quality of life (HRQoL)	1 year	assessed by PedsQL Generic Core scale 4.0

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L	1 year	EQ-5D-5L is a 5 dimension and 5 level Questionnaire from the Euro Qol Group (supported by the Euro QolGroup Association and Euro Qol Research Foundation). Health states which is defined by EQ-5D-5L-answers, is assigned a score between 0 and 1 by applying preference weights. In Norway it has been common to use preference weights obtained from a sample of the general population in the UK. Norwegian preference weights will be available in near future. EQ-5D is the name of the instrument and is not an acronym. EQ-5D is the correct term to use in print or verbally.
Mood and Feelings Questionnaire	1 year	Short Mood and Feelings Questionnaire
Fatigue Questionnaire	1 year	PedsQL Multidimensional Fatigue Questionnaire
Self-reported follow-up, School functioning and participation in Leisure activities	1 year	Self-report form with yes/no answers regarding follow-up from health care personnel, follow-up from school, school attendance and participation in leisure activities.

Trial Locations

Locations (1)

Barne og ungdomsklinikken (Children's Clinic); 🇳🇴 Trondheim, Norway