Coping With Chronic Fatigue Syndrome: Development of a Community-based Patient Education Program

University of Oslo (UIO)

Status: Completed

Conditions: Coping; Patient Education; Chronic Fatigue Syndrome

Treatments: Behavioral: Patient education program

Study type: Interventional

Funder types: Other

Identifiers

NCT01765725

36IAJ3 (Other Grant/Funding Number)

2011/894/REK nord (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

Control group

No Intervention group

Description:

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 group

Description:

Patient education program

Treatment:

Behavioral: Patient education program