Back to resultsRehabilitation of Adolescents Living With Chronic Fatigue
Primary Purpose
Fatigue Syndrome, Chronic
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Health promoting dialogue
standard treatment / treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue Syndrome, Chronic focused on measuring Adolescent, Fatigue, Rehabilitation, Health Promotion, Health-related Quality of Life, Sense of Coherence, Emotions, Mood, Leisure Activities
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 - 1.4.2020.
- 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
Sites / Locations
- Barne og ungdomsklinikken (Children's Clinic)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Health promoting dialogue in addition to treatment as usual
Treatment as usual
Arm Description
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.
Follow-up from primary and secondary health care, and from Schools, which is individually customized due to fatigue and other symptoms present..
Outcomes
Primary Outcome Measures
Health-related quality of life (HRQoL)
assessed by PedsQL Generic Core scale 4.0
Secondary Outcome Measures
Fatigue Questionnaire
PedsQL Multidimensional Fatigue Questionnaire
Mood and Feelings Questionnaire
Short Mood and Feelings Questionnaire
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.
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.
Full Information
NCT ID
NCT04177459
First Posted
November 19, 2019
Last Updated
June 23, 2020
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Trondheim Kommune
1. Study Identification
Unique Protocol Identification Number
NCT04177459
Brief Title
Rehabilitation of Adolescents Living With Chronic Fatigue
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Covid-19
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Trondheim Kommune
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue Syndrome, Chronic
Keywords
Adolescent, Fatigue, Rehabilitation, Health Promotion, Health-related Quality of Life, Sense of Coherence, Emotions, Mood, Leisure Activities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health promoting dialogue in addition to treatment as usual
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Follow-up from primary and secondary health care, and from Schools, which is individually customized due to fatigue and other symptoms present..
Intervention Type
Behavioral
Intervention Name(s)
Health promoting dialogue
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standard treatment / treatment as usual
Intervention Description
Follow-up from primary and secondary health care, and from schools.
Primary Outcome Measure Information:
Title
Health-related quality of life (HRQoL)
Description
assessed by PedsQL Generic Core scale 4.0
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Fatigue Questionnaire
Description
PedsQL Multidimensional Fatigue Questionnaire
Time Frame
1 year
Title
Mood and Feelings Questionnaire
Description
Short Mood and Feelings Questionnaire
Time Frame
1 year
Title
Self-reported follow-up, School functioning and participation in Leisure activities
Description
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.
Time Frame
1 year
Title
EQ-5D-5L
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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 - 1.4.2020.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Selvaag, md phd
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Torstein Baade Rø, md phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barne og ungdomsklinikken (Children's Clinic)
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The standard consent form used in this study is developed by the regional ethical committee, and does not include consent to make individual participant data available for other researchers.
Learn more about this trial
Rehabilitation of Adolescents Living With Chronic Fatigue
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