Rehabilitation of Adolescents Living With Chronic Fatigue

NCT ID: NCT04177459

Last Updated: 2020-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-06

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fatigue Syndrome, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Health promoting dialogue

Intervention Type BEHAVIORAL

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.

standard treatment / treatment as usual

Intervention Type OTHER

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

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..

Group Type ACTIVE_COMPARATOR

standard treatment / treatment as usual

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

standard treatment / treatment as usual

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

Trondheim Kommune

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Selvaag, md phd

Role: STUDY_DIRECTOR

St. Olavs Hospital

Torstein Baade Rø, md phd

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Barne og ungdomsklinikken (Children's Clinic)

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2019/1081

Identifier Type: -

Identifier Source: org_study_id

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