Rehabilitation of Adolescents Living With Chronic Fatigue

Sponsor

St. Olavs Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT04177459

Collaborator

Norwegian University of Science and Technology (Other), Trondheim Kommune (Other)

Enrollment

Location

Arms

4.8

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fatigue Syndrome, Chronic	Behavioral: Health promoting dialogue Other: standard treatment / treatment as usual	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Dec 6, 2019

Actual Primary Completion Date :

Apr 30, 2020

Actual Study Completion Date :

Apr 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Health promoting dialogue in addition to treatment as usual Health promoting dialogues in addition to follow-up from primary and secondary health care, and from schools, which is individually customized due to fatigue and other symptoms present.	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.
Active Comparator: Treatment as usual Follow-up from primary and secondary health care, and from Schools, which is individually customized due to fatigue and other symptoms present..	Other: standard treatment / treatment as usual Follow-up from primary and secondary health care, and from schools.

Arm

Intervention/Treatment

Experimental: Health promoting dialogue in addition to treatment as usual

Health promoting dialogues in addition to follow-up from primary and secondary health care, and from schools, which is individually customized due to fatigue and other symptoms present.

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.

Active Comparator: Treatment as usual

Follow-up from primary and secondary health care, and from Schools, which is individually customized due to fatigue and other symptoms present..

Other: standard treatment / treatment as usual

Follow-up from primary and secondary health care, and from schools.

Outcome Measures

Primary Outcome Measures

Health-related quality of life (HRQoL) [1 year]
assessed by PedsQL Generic Core scale 4.0

Secondary Outcome Measures

Fatigue Questionnaire [1 year]
PedsQL Multidimensional Fatigue Questionnaire
Mood and Feelings Questionnaire [1 year]
Short Mood and Feelings 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barne og ungdomsklinikken (Children's Clinic)	Trondheim		Norway

Sponsors and Collaborators

St. Olavs Hospital
Norwegian University of Science and Technology
Trondheim Kommune

Investigators

Study Director: Elisabeth Selvaag, md phd, St. Olavs Hospital
Principal Investigator: Torstein Baade Rø, md phd, Norwegian University of Science and Technology