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

Primary Purpose

Chronic Fatigue Syndrome, Coping, Patient Education

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Patient education program
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Fatigue Syndrome focused on measuring Chronic Fatigue Syndrome, Coping, Patient education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Irma Pinxsterhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Patient education program

Arm Description

The control group will be offered to take part in the patient education group as soon as they have completed the last outcome evaluations

Patient education program

Outcomes

Primary Outcome Measures

SF-36, subscale Physical functioning.
Measures change in physical functioning.
Illness Management Questionnaire (IMQ).
Measures change in ways of coping with CFS.

Secondary Outcome Measures

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.
Fatigue Severity Scale (FSS).
Measures change in fatigue-related severity, symptomatology, and functional disability.
Illness Cognition Questionnaire (ICQ)
Measure change in helplessness, acceptance, and perceived benefits.
The Fennell Phase Inventory (FPI)
Measures change in coping and progression through four phases: crisis phase, stabilization phase, resolution phase, and integration phase.
Hospital Anxiety and Depression Scale (HADS)
Measures change in anxiety and depression.
Perceived Stress Scale (PSS)- 10 items
Measures change in global perceived stress.
Brief Illness Perception Questionnaire (BIPQ)
Measures change in cognitive and emotional representations of illness.
Self-efficacy Scale (SE24)
Measures change in perceived control with respect to CFS complains.
Self-defined fatigue and pain scale
Measures change in perceived fatigue and pain.

Full Information

First Posted
January 4, 2013
Last Updated
October 13, 2017
Sponsor
Oslo University Hospital
Collaborators
Stiftelsen Helse og Rehabilitering
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1. Study Identification

Unique Protocol Identification Number
NCT01765725
Brief Title
Coping With Chronic Fatigue Syndrome: Development of a Community-based Patient Education Program
Official Title
Coping With Chronic Fatigue Syndrome: Development of a Community-based Patient Education Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Stiftelsen Helse og Rehabilitering

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome, Coping, Patient Education
Keywords
Chronic Fatigue Syndrome, Coping, Patient education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will be offered to take part in the patient education group as soon as they have completed the last outcome evaluations
Arm Title
Patient education program
Arm Type
Experimental
Arm Description
Patient education program
Intervention Type
Behavioral
Intervention Name(s)
Patient education program
Intervention Description
Patient education program, 8 meetings, every other week, 2,5 hours per meeting.
Primary Outcome Measure Information:
Title
SF-36, subscale Physical functioning.
Description
Measures change in physical functioning.
Time Frame
T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Title
Illness Management Questionnaire (IMQ).
Description
Measures change in ways of coping with CFS.
Time Frame
T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Secondary Outcome Measure Information:
Title
The SF-36 (total score and subscale role limitations due to physical limitations).
Description
The SF-36 total score measures change in functional status related to health. The subscale measures change in role limitations due to physical limitations.
Time Frame
T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Title
Fatigue Severity Scale (FSS).
Description
Measures change in fatigue-related severity, symptomatology, and functional disability.
Time Frame
T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Title
Illness Cognition Questionnaire (ICQ)
Description
Measure change in helplessness, acceptance, and perceived benefits.
Time Frame
T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Title
The Fennell Phase Inventory (FPI)
Description
Measures change in coping and progression through four phases: crisis phase, stabilization phase, resolution phase, and integration phase.
Time Frame
T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Measures change in anxiety and depression.
Time Frame
T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Title
Perceived Stress Scale (PSS)- 10 items
Description
Measures change in global perceived stress.
Time Frame
T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Title
Brief Illness Perception Questionnaire (BIPQ)
Description
Measures change in cognitive and emotional representations of illness.
Time Frame
T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Title
Self-efficacy Scale (SE24)
Description
Measures change in perceived control with respect to CFS complains.
Time Frame
T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.
Title
Self-defined fatigue and pain scale
Description
Measures change in perceived fatigue and pain.
Time Frame
T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Unni Sveen, Ph.d.
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Irma Pinxsterhuis, M.Sc.
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dag Kvale, Ph.d.
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Irma Pinxsterhuis
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

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

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