Rehabilitation of Adolescents Living With Chronic Fatigue

Fatigue Syndrome, Chronic Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04177459
• Other study ID #: 2019/1081
• Status: Terminated
• Phase: N/A
• Start date: December 6, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: June 2020
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Fatigue Syndrome, Chronic

Intervention

Behavioral:
• Health promoting dialogue
Health promoting dialogues based on the salutogenic theory, focusing on resources within and around the individual, and on coping strategies. Seven individual dialogues for each participant, individually adapted due to the fatigue. The intervention is offered in the participants home or at the local hospital, dependent on the participants fatigue and what is preferred.

Other:
• standard treatment / treatment as usual
Follow-up from primary and secondary health care, and from schools.

Locations

Country	Name	City	State
Norway	Barne og ungdomsklinikken (Children's Clinic)	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology, Trondheim Kommune

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life (HRQoL)	assessed by PedsQL Generic Core scale 4.0	1 year
Secondary	Fatigue Questionnaire	PedsQL Multidimensional Fatigue Questionnaire	1 year
Secondary	Mood and Feelings Questionnaire	Short Mood and Feelings Questionnaire	1 year
Secondary	Self-reported follow-up, School functioning and participation in Leisure activities	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.	1 year
Secondary	EQ-5D-5L	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.	1 year