Coping With Chronic Fatigue Syndrome: Development of a Community-based Patient Education Program
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Fatigue Syndrome
- Sponsor
- Oslo University Hospital
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- SF-36, subscale Physical functioning.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Unni Sveen
Associate professor
Oslo University Hospital
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Self-efficacy Scale (SE24)(T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.)
- Hospital Anxiety and Depression Scale (HADS)(T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.)
- Brief Illness Perception Questionnaire (BIPQ)(T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.)
- Illness Cognition Questionnaire (ICQ)(T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.)
- Perceived Stress Scale (PSS)- 10 items(T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.)
- Fatigue Severity Scale (FSS).(T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.)
- The SF-36 (total score and subscale role limitations due to physical limitations).(T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.)
- The Fennell Phase Inventory (FPI)(T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.)
- Self-defined fatigue and pain scale(T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.)