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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Fatigue Syndrome; Patient Education; Coping
• Intervention / Treatment: Behavioral: Patient education program

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 Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Irma Pinxsterhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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	Behavioral: Patient education program; Patient education program, 8 meetings, every other week, 2,5 hours per meeting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36, subscale Physical functioning.	Measures change in physical functioning.	T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Stiftelsen Helse og Rehabilitering
• Investigators: Study Director: Unni Sveen, Ph.d., Oslo University Hospital; Principal Investigator: Irma Pinxsterhuis, M.Sc., Oslo University Hospital; Study Chair: Dag Kvale, Ph.d., Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: January 4, 2013
• First Submitted That Met QC Criteria: January 8, 2013
• First Posted (ESTIMATE): January 10, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 13, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Patient education; Coping; Chronic Fatigue Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Fatigue Syndrome, Chronic
• Other Study ID Numbers: 2011/894/REK nord (REGISTRY: REK nord); 36IAJ3 (OTHER_GRANT: Extra Stiftelsen Helse og Rehabilitering)