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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stiftelsen Helse og Rehabilitering
Information provided by (Responsible Party):
Unni Sveen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01765725
First received: January 4, 2013
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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 Intervention
Chronic Fatigue Syndrome
Coping
Patient Education
Behavioral: Patient education program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Coping With Chronic Fatigue Syndrome: Development of a Community-based Patient Education Program

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • SF-36, subscale Physical functioning. [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ] [ Designated as safety issue: No ]
    Measures change in physical functioning.

  • Illness Management Questionnaire (IMQ). [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ] [ Designated as safety issue: No ]
    Measures change in ways of coping with CFS.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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). [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ] [ Designated as safety issue: No ]
    Measures change in fatigue-related severity, symptomatology, and functional disability.

  • Illness Cognition Questionnaire (ICQ) [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ] [ Designated as safety issue: No ]
    Measure change in helplessness, acceptance, and perceived benefits.

  • The Fennell Phase Inventory (FPI) [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ] [ Designated as safety issue: No ]
    Measures change in coping and progression through four phases: crisis phase, stabilization phase, resolution phase, and integration phase.

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ] [ Designated as safety issue: No ]
    Measures change in anxiety and depression.

  • Perceived Stress Scale (PSS)- 10 items [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ] [ Designated as safety issue: No ]
    Measures change in global perceived stress.

  • Brief Illness Perception Questionnaire (BIPQ) [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ] [ Designated as safety issue: No ]
    Measures change in cognitive and emotional representations of illness.

  • Self-efficacy Scale (SE24) [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ] [ Designated as safety issue: No ]
    Measures change in perceived control with respect to CFS complains.

  • Self-defined fatigue and pain scale [ Time Frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. ] [ Designated as safety issue: No ]
    Measures change in perceived fatigue and pain.


Estimated Enrollment: 150
Study Start Date: April 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, 36IAJ3
Study First Received: January 4, 2013
Last Updated: January 10, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on August 27, 2014