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Rehabilitation of Adolescents Living With Chronic Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04177459
Recruitment Status : Terminated (Covid-19)
First Posted : November 26, 2019
Last Update Posted : June 25, 2020
Sponsor:
Collaborators:
Norwegian University of Science and Technology
Trondheim Kommune
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fatigue Syndrome, Chronic Behavioral: Health promoting dialogue Other: standard treatment / treatment as usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : December 6, 2019
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Health-related quality of life (HRQoL) [ Time Frame: 1 year ]
    assessed by PedsQL Generic Core scale 4.0


Secondary Outcome Measures :
  1. Fatigue Questionnaire [ Time Frame: 1 year ]
    PedsQL Multidimensional Fatigue Questionnaire

  2. Mood and Feelings Questionnaire [ Time Frame: 1 year ]
    Short Mood and Feelings Questionnaire

  3. Self-reported follow-up, School functioning and participation in Leisure activities [ Time Frame: 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.

  4. EQ-5D-5L [ Time Frame: 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.



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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04177459


Locations
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Norway
Barne og ungdomsklinikken (Children's Clinic)
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Trondheim Kommune
Investigators
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Study Director: Elisabeth Selvaag, md phd St. Olavs Hospital
Principal Investigator: Torstein Baade Rø, md phd Norwegian University of Science and Technology
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT04177459    
Other Study ID Numbers: 2019/1081
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Adolescent
Fatigue
Rehabilitation
Health Promotion
Health-related Quality of Life
Sense of Coherence
Emotions
Mood
Leisure Activities
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Fatigue
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases