Clinical trial NCT01765725: Coping With Chronic Fatigue Syndrome: Development of a Community-based Patient Education Program
Official title: Coping With Chronic Fatigue Syndrome: Development of a Community-based Patient Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Fatigue Syndrome
Coping
Patient Education
Keywords: Chronic Fatigue Syndrome
Coping
Patient education
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Stiftelsen Helse og Rehabilitering
First posted: 2013-01-10
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: SF-36, subscale Physical functioning.
timeFrame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
measure: Illness Management Questionnaire (IMQ).
timeFrame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Secondary outcomes:
measure: The SF-36 (total score and subscale role limitations due to physical limitations).
timeFrame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
measure: Fatigue Severity Scale (FSS).
timeFrame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
measure: Illness Cognition Questionnaire (ICQ)
timeFrame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
measure: The Fennell Phase Inventory (FPI)
timeFrame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
measure: Perceived Stress Scale (PSS)- 10 items
timeFrame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
measure: Brief Illness Perception Questionnaire (BIPQ)
timeFrame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
measure: Self-efficacy Scale (SE24)
timeFrame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
measure: Self-defined fatigue and pain scale
timeFrame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Irma Pinxsterhuis
Study officials:
affiliation: Oslo University Hospital
name: Unni Sveen, Ph.d.
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital
name: Irma Pinxsterhuis, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Dag Kvale, Ph.d.
role: STUDY_CHAIR
References: