NCT04177459

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

December 6, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

November 19, 2019

Last Update Submit

June 23, 2020

Conditions

Fatigue Syndrome, Chronic

Keywords

AdolescentFatigueRehabilitationHealth PromotionHealth-related Quality of LifeSense of CoherenceEmotionsMoodLeisure Activities

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life (HRQoL)

    assessed by PedsQL Generic Core scale 4.0

    1 year

Secondary Outcomes (4)

  • Fatigue Questionnaire

    1 year

  • Mood and Feelings Questionnaire

    1 year

  • Self-reported follow-up, School functioning and participation in Leisure activities

    1 year

  • EQ-5D-5L

    1 year

Study Arms (2)

Health promoting dialogue in addition to treatment as usual

EXPERIMENTAL

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 dialogueOther: standard treatment / treatment as usual

Treatment as usual

ACTIVE COMPARATOR

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

Interventions

Health promoting dialogueBEHAVIORAL

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.

Health promoting dialogue in addition to treatment as usual
standard treatment / treatment as usualOTHER

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

Health promoting dialogue in addition to treatment as usualTreatment as usual

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barne og ungdomsklinikken (Children's Clinic)

Trondheim, Norway

Location

MeSH Terms

Conditions

Fatigue Syndrome, ChronicFatigue

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Elisabeth Selvaag, md phd

    St. Olavs Hospital

    STUDY DIRECTOR

  • Torstein Baade Rø, md phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 26, 2019

Study Start

December 6, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

June 25, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

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.

Locations

NO(1)