We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01765725
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : October 16, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Chronic Fatigue Syndrome Coping Patient Education 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 Design

Study Type : Interventional  (Clinical Trial)
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 : April 2011
Primary Completion Date : December 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.


Outcome Measures

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

  2. Illness Management Questionnaire (IMQ). [ Time Frame: 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 :
  1. 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. ]
    The SF-36 total score measures change in functional status related to health. The subscale measures change in role limitations due to physical limitations.

  2. Fatigue Severity Scale (FSS). [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ]
    Measures change in fatigue-related severity, symptomatology, and functional disability.

  3. Illness Cognition Questionnaire (ICQ) [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ]
    Measure change in helplessness, acceptance, and perceived benefits.

  4. The Fennell Phase Inventory (FPI) [ Time Frame: 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.

  5. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ]
    Measures change in anxiety and depression.

  6. Perceived Stress Scale (PSS)- 10 items [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ]
    Measures change in global perceived stress.

  7. Brief Illness Perception Questionnaire (BIPQ) [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ]
    Measures change in cognitive and emotional representations of illness.

  8. Self-efficacy Scale (SE24) [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ]
    Measures change in perceived control with respect to CFS complains.

  9. Self-defined fatigue and pain scale [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ]
    Measures change in perceived fatigue and pain.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765725


Locations
Norway
Irma Pinxsterhuis
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
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
More Information

Responsible Party: Unni Sveen, Associate professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01765725     History of Changes
Other Study ID Numbers: 2011/894/REK nord
2011/894/REK nord ( Registry Identifier: REK nord )
36IAJ3 ( Other Grant/Funding Number: Extra Stiftelsen Helse og Rehabilitering )
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017

Keywords provided by Unni Sveen, Oslo University Hospital:
Chronic Fatigue Syndrome
Coping
Patient education

Additional relevant MeSH terms:
Syndrome
Fatigue
Fatigue Syndrome, Chronic
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases