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

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01765725

Collaborator

Stiftelsen Helse og Rehabilitering (Other)

146

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue Syndrome Coping Patient Education	Behavioral: Patient education program	N/A

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

Study Type:

Interventional

Actual Enrollment :

146 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group 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	Behavioral: Patient education program Patient education program, 8 meetings, every other week, 2,5 hours per meeting.

Arm

Intervention/Treatment

No Intervention: Control group

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

Behavioral: Patient education program

Patient education program, 8 meetings, every other week, 2,5 hours per meeting.

Outcome Measures

Primary Outcome Measures

SF-36, subscale Physical functioning. [T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.]
Measures change in physical functioning.
Illness Management Questionnaire (IMQ). [T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.]
Measures change in ways of coping with CFS.

Secondary Outcome Measures

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 SF-36 total score measures change in functional status related to health. The subscale measures change in role limitations due to physical limitations.
Fatigue Severity Scale (FSS). [T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.]
Measures change in fatigue-related severity, symptomatology, and functional disability.
Illness Cognition Questionnaire (ICQ) [T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.]
Measure change in helplessness, acceptance, and perceived benefits.
The Fennell Phase Inventory (FPI) [T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.]
Measures change in coping and progression through four phases: crisis phase, stabilization phase, resolution phase, and integration phase.
Hospital Anxiety and Depression Scale (HADS) [T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.]
Measures change in anxiety and depression.
Perceived Stress Scale (PSS)- 10 items [T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.]
Measures change in global perceived stress.
Brief Illness Perception Questionnaire (BIPQ) [T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.]
Measures change in cognitive and emotional representations of illness.
Self-efficacy Scale (SE24) [T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.]
Measures change in perceived control with respect to CFS complains.
Self-defined fatigue and pain scale [T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.]
Measures change in perceived fatigue and pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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