Rehabilitation of Adolescents Living With Chronic Fatigue

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.

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.

Study Overview

• Status: Terminated
• Conditions: Fatigue Syndrome, Chronic
• Intervention / Treatment: Behavioral: Health promoting dialogue; Other: standard treatment / treatment as usual

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • Barne og ungdomsklinikken (Children's Clinic)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life (HRQoL)	assessed by PedsQL Generic Core scale 4.0	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Questionnaire	PedsQL Multidimensional Fatigue Questionnaire	1 year
Mood and Feelings Questionnaire	Short Mood and Feelings Questionnaire	1 year
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
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

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2019
• Primary Completion (ACTUAL): April 30, 2020
• Study Completion (ACTUAL): April 30, 2020

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (ACTUAL): November 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Adolescent; Rehabilitation; Fatigue; Health Promotion; Emotions; Mood; Health-related Quality of Life; Sense of Coherence; Leisure Activities
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Fatigue; Fatigue Syndrome, Chronic
• Other Study ID Numbers: 2019/1081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No