Overview

This trial is active, not recruiting.

Conditions chronic fatigue syndrome, coping, patient education
Treatment patient education program
Sponsor Oslo University Hospital
Collaborator Stiftelsen Helse og Rehabilitering
Start date April 2011
End date September 2013
Trial size 150 participants
Trial identifier NCT01765725, 2011/894/REK nord, 36IAJ3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(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
(Experimental)
Patient education program
patient education program
Patient education program, 8 meetings, every other week, 2,5 hours per meeting.

Primary Outcomes

Measure
SF-36, subscale Physical functioning.
time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Illness Management Questionnaire (IMQ).
time frame: 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).
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Coping With Chronic Fatigue Syndrome: Development of a Community-based Patient Education Program
Principal investigator Irma Pinxsterhuis, M.Sc.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Oslo University Hospital.