Chronic Fatigue SyndromeNCT01765725
Coping With Chronic Fatigue Syndrome: Development of a Community-based Patient Education Program
A study testing Patient education program in people with Chronic Fatigue Syndrome and Coping, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The aim of the study is to develop, carry out, evaluate and measure the effects of a new patient education program for patients with Chronic Fatigue Syndrome (CFS)in primary healthcare. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Fatigue Syndrome, Coping, Patient Education
- What is being tested?
- Patient education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2011to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Meets Fukuda's research diagnostic criteria and Canadian CFS case definition
- Has given oral and written informed consent
- Able to tak part in the program that lasts 2,5 hours in addition to transport to and from the location for intervention.
Who cannot join
- Psychosis or other severe psychiatric diseases, severe personality disturbances and/or substance dependency
- Pregnancy
- Not being able to understand, speak and read Norwegian
- Not willing to accept random assignment
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to develop, carry out, evaluate and measure the effects of a new patient education program for patients with Chronic Fatigue Syndrome (CFS)in primary healthcare.
In an randomized controlled trial design the effects of the patient education program on coping, physical functioning, fatigue, pain, acceptance, anxiety, depression, quality of life, self- efficacy, and illness perception will be compared with treatment as usual.
The results of the main project will lead to the elaboration of the final patient education program that can be implemented in primary health care, as well as development of a training program for future program-conductors.
Read the detailed description
The project is a single blind randomized controlled trial. A total of 150 participants will be included in this study and randomly allocated to the intervention- or the control group. The 75 participants in the intervention group will be allocated to 6 groups. The control group will be offered to take part in the patient education program as soon as they have completed the last outcome evaluations.
- Conditions
- Chronic Fatigue Syndrome, Coping, Patient Education
- Being tested
- Patient education program
- Keywords
- Chronic Fatigue Syndrome, Coping, Patient education
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education programBehavioural
Patient education program, 8 meetings, every other week, 2,5 hours per meeting.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will be offered to take part in the patient education group as soon as they have completed the last outcome evaluations |
| Patient education program | Experimental | Patient education program Receives: Behavioral: Patient education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36, subscale Physical functioning.
Measures change in physical functioning.
Measured: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Illness Management Questionnaire (IMQ).
Measures change in ways of coping with CFS.
Measured: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Secondary outcomes (9)
The SF-36 (total score and subscale role limitations due to physical limitations).
The SF-36 total score measures change in functional status related to health. The subscale measures change in role limitations due to physical limitations.
Measured: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Fatigue Severity Scale (FSS).
Measures change in fatigue-related severity, symptomatology, and functional disability.
Measured: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Illness Cognition Questionnaire (ICQ)
Measure change in helplessness, acceptance, and perceived benefits.
Measured: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
The Fennell Phase Inventory (FPI)
Measures change in coping and progression through four phases: crisis phase, stabilization phase, resolution phase, and integration phase.
Measured: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Hospital Anxiety and Depression Scale (HADS)
Measures change in anxiety and depression.
Measured: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Perceived Stress Scale (PSS)- 10 items
Measures change in global perceived stress.
Measured: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Brief Illness Perception Questionnaire (BIPQ)
Measures change in cognitive and emotional representations of illness.
Measured: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Self-efficacy Scale (SE24)
Measures change in perceived control with respect to CFS complains.
Measured: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Self-defined fatigue and pain scale
Measures change in perceived fatigue and pain.
Measured: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startApr 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Oslo University 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering
- Responsible party
- Principal investigator, Unni Sveen, Oslo University Hospital
- Investigators
- Unni Sveen, Ph.d., Study director, Oslo University HospitalIrma Pinxsterhuis, M.Sc., Principal investigator, Oslo University HospitalDag Kvale, Ph.d., Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765725
- Sponsor's protocol ID
- 2011/894/REK nord
- Other IDs
- 2011/894/REK nord, 36IAJ3
- Status last verified
- Oct 2017
- First submitted
- 4 Jan 2013
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping With Chronic Fatigue Syndrome: Development of a Community-based Patient Education Program
- ClinicalTrials.gov ID
- NCT01765725
- Acronym / sponsor ID
- 2011/894/REK nord
- Conditions
- Chronic Fatigue Syndrome, Coping, Patient Education
- Keywords
- Chronic Fatigue Syndrome, Coping, Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering
- Study start
- Apr 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jan 2013 (estimated)
- 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.
The aim of the study is to develop, carry out, evaluate and measure the effects of a new patient education program for patients with Chronic Fatigue Syndrome (CFS)in primary healthcare.
In an randomized controlled trial design the effects of the patient education program on coping, physical functioning, fatigue, pain, acceptance, anxiety, depression, quality of life, self- efficacy, and illness perception will be compared with treatment as usual.
The results of the main project will lead to the elaboration of the final patient education program that can be implemented in primary health care, as well as development of a training program for future program-conductors.
Detailed description
The project is a single blind randomized controlled trial. A total of 150 participants will be included in this study and randomly allocated to the intervention- or the control group. The 75 participants in the intervention group will be allocated to 6 groups. The control group will be offered to take part in the patient education program as soon as they have completed the last outcome evaluations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will be offered to take part in the patient education group as soon as they have completed the last outcome evaluations |
| Patient education program | Experimental | Behavioral: Patient education programPatient education program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older
- Meets Fukuda's research diagnostic criteria and Canadian CFS case definition
- Has given oral and written informed consent
- Able to tak part in the program that lasts 2,5 hours in addition to transport to and from the location for intervention.
Key exclusion criteria (4 listed)
- Psychosis or other severe psychiatric diseases, severe personality disturbances and/or substance dependency
- Pregnancy
- Not being able to understand, speak and read Norwegian
- Not willing to accept random assignment
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 |
|---|---|---|
| Patient education programPatient education program, 8 meetings, every other week, 2,5 hours per meeting. | Behavioural | Patient education program |
Primary outcome
SF-36, subscale Physical functioning.
Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Measures change in physical functioning.
Illness Management Questionnaire (IMQ).
Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Measures change in ways of coping with CFS.
9 secondary outcomes
The SF-36 (total score and subscale role limitations due to physical limitations).
Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Fatigue Severity Scale (FSS).
Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Illness Cognition Questionnaire (ICQ)
Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
The Fennell Phase Inventory (FPI)
Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Hospital Anxiety and Depression Scale (HADS)
Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Perceived Stress Scale (PSS)- 10 items
Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Brief Illness Perception Questionnaire (BIPQ)
Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Self-efficacy Scale (SE24)
Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Self-defined fatigue and pain scale
Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
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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.
Unni Sveen, Ph.d. study director
Oslo University Hospital
Irma Pinxsterhuis, M.Sc. principal investigator
Oslo University Hospital
Dag Kvale, Ph.d. study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education program in people with Chronic Fatigue Syndrome and Coping, run by Oslo University 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 16 Oct 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SF-36, subscale Physical functioning. (time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.). The study lists 2 primary outcomes in all. 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 16 Oct 2017.