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

Chronic Fatigue Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765725
• Other study ID #: 2011/894/REK nord
• Secondary ID: 2011/894/REK nor
• Status: Completed
• Phase: N/A
• First received: January 4, 2013
• Last updated: October 13, 2017
• Start date: April 2011
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Coping
• Fatigue
• Fatigue Syndrome, Chronic
• Patient Education
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Norway	Irma Pinxsterhuis	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Stiftelsen Helse og Rehabilitering

Country where clinical trial is conducted

Norway, 

Outcome

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