NCT01765725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

5.7 years

First QC Date

January 4, 2013

Last Update Submit

October 13, 2017

Conditions

Chronic Fatigue SyndromeCopingPatient Education

Keywords

Chronic Fatigue SyndromeCopingPatient education

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • The SF-36 (total score and subscale role limitations due to physical limitations).

    T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

  • Fatigue Severity Scale (FSS).

    T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

  • Illness Cognition Questionnaire (ICQ)

    T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

  • The Fennell Phase Inventory (FPI)

    T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

  • Hospital Anxiety and Depression Scale (HADS)

    T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

  • +4 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

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

EXPERIMENTAL

Patient education program

Behavioral: Patient education program

Interventions

Patient education programBEHAVIORAL

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

Patient education program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irma Pinxsterhuis

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Unni Sveen, Ph.d.

    Oslo University Hospital

    STUDY DIRECTOR

  • Irma Pinxsterhuis, M.Sc.

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

  • Dag Kvale, Ph.d.

    Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 10, 2013

Study Start

April 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 16, 2017

Record last verified: 2017-10

Locations

NO(1)