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

NCT ID: NCT01765725

Last Updated: 2017-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Fatigue Syndrome Coping Patient Education

Keywords

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Chronic Fatigue Syndrome Coping Patient education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

Patient education program

Patient education program

Group Type EXPERIMENTAL

Patient education program

Intervention Type BEHAVIORAL

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

Interventions

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Patient education program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stiftelsen Helse og Rehabilitering

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Unni Sveen

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Unni Sveen, Ph.d.

Role: STUDY_DIRECTOR

Oslo University Hospital

Irma Pinxsterhuis, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Dag Kvale, Ph.d.

Role: STUDY_CHAIR

Oslo University Hospital

Locations

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Irma Pinxsterhuis

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2011/894/REK nord

Identifier Type: REGISTRY

Identifier Source: secondary_id

36IAJ3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011/894/REK nord

Identifier Type: -

Identifier Source: org_study_id