Fatigue Syndrome, ChronicNCT04177459
Rehabilitation of Adolescents Living With Chronic Fatigue
A study testing Health promoting dialogue and standard treatment / treatment as usual in people with Fatigue Syndrome, Chronic, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Fatigue Syndrome, Chronic
- What is being tested?
- Health promoting dialogue and standard treatment / treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNorway
- Study dates
- 6 Dec 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Fatigue Syndrome, Chronic
- Being tested
- Health promoting dialogue, standard treatment / treatment as usual
- Keywords
- Adolescent, Fatigue, Rehabilitation, Health Promotion, Health-related Quality of Life, Sense of Coherence, Emotions, Mood, Leisure Activities
- Medical subject headings
- Fatigue Syndrome, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promoting dialogueBehavioural
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 usualOther
Follow-up from primary and secondary health care, and from schools.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Health promoting dialogue; Other: 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.. Receives: Other: standard treatment / treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (HRQoL)
assessed by PedsQL Generic Core scale 4.0
Measured: 1 year
Secondary outcomes (4)
Fatigue Questionnaire
PedsQL Multidimensional Fatigue Questionnaire
Measured: 1 year
Mood and Feelings Questionnaire
Short Mood and Feelings Questionnaire
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start6 Dec 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Trondheim Kommune
- Responsible party
- Sponsor
- Investigators
- Elisabeth Selvaag, md phd, Study director, St. Olavs HospitalTorstein Baade Rø, md phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177459
- Sponsor's protocol ID
- 2019/1081
- Status last verified
- Jun 2020
- First submitted
- 19 Nov 2019
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04177459
- Acronym / sponsor ID
- 2019/1081
- Conditions
- Fatigue Syndrome, Chronic
- Keywords
- Adolescent, Fatigue, Rehabilitation, Health Promotion, Health-related Quality of Life, Sense of Coherence, Emotions, Mood
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19
- Enrolment
- 3 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Trondheim Kommune
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health promoting dialogue in addition to treatment as usual | Experimental | Behavioral: Health promoting dialogue, Other: standard treatment / treatment as usualHealth 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. |
| Treatment as usual | Active comparator | Other: standard treatment / treatment as usualFollow-up from primary and secondary health care, and from Schools, which is individually customized due to fatigue and other symptoms present.. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health promoting dialogueHealth 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. | Behavioural | Health promoting dialogue in addition to treatment as usual |
| standard treatment / treatment as usualFollow-up from primary and secondary health care, and from schools. | Other | Health promoting dialogue in addition to treatment as usual, Treatment as usual |
Primary outcome
Health-related quality of life (HRQoL)
Time frame: 1 year
assessed by PedsQL Generic Core scale 4.0
4 secondary outcomes
Fatigue Questionnaire
Time frame: 1 year
Mood and Feelings Questionnaire
Time frame: 1 year
Self-reported follow-up, School functioning and participation in Leisure activities
Time frame: 1 year
EQ-5D-5L
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Selvaag, md phd study director
St. Olavs Hospital
Torstein Baade Rø, md phd principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health promoting dialogue and standard treatment / treatment as usual in people with Fatigue Syndrome, Chronic, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (HRQoL) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.