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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR944 |
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Date of registration:
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29/03/2007 |
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Primary sponsor: |
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Public title:
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Group training for hepatitis C patients to improve quality of life.
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Scientific title:
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Group training for hepatitis C patients to improve quality of life. - Intervention for hepatitis C patients |
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Date of first enrolment:
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1/3/2007 |
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Target sample size:
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300 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=944 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Not applicable; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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A.
Spijker, van 't |
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Address:
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Erasmus Medical Center,
Department of Psychiatry and Psychotherapy,
P.O. Box 2040
Rotterdam
The Netherlands |
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Telephone:
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+ 31 10-4087839 |
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Email:
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a.vantspijker@erasmusmc.nl |
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Affiliation:
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Name:
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A.
Beerthuizen |
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Address:
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Erasmus Medical Center, Department of Psychiatry and Psychotherapy,
P.O. Box 2040
3000 CA
Rotterdam
The Netherlands |
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Telephone:
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+31 (0)10 4088234 |
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Email:
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a.beerthuizen@erasmusmc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Hepatitis C;
2. Age 18 years or older
Exclusion criteria: 1. Patients with an insufficient grasp of the Dutch language to be able to participate in a training project;
2. Patients with a psychiatric illness;
3. Patients who are / have been succesfully treated with Interferon
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Hepatitis C, Intervention, Quality of life, Psychosocial
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Intervention(s)
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150 patients will participate in a group training (problem solving therapy), to improve quality of life by teaching patients skills that aid in coping with the consequences of the disease. This training consists of 8 sessions of 2 hours. To evaluate this training, participants as well as the 150 controls will complete a questionnaire before the start of the training, right after and 6 months after the training. When the intervention is effective, controls will participate in this training after the end of this research project.
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Primary Outcome(s)
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Quality of life (SF-36), the participants will complete this questionnaire at baseline, T1 (right after the training) and at T2 (6 months after the last session of the training)
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Secondary Outcome(s)
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Health status (Euroqol-5D), Health & Labour Questionnaire, Depression
(Beck Depression Inventory, BDI), problem orientation and problem
solving skills (Social Problem Solving Inventory, SPSI).
The participants will complete these questionnaires at baseline, T1 and
T2 (see primary outcome).
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Secondary ID(s)
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ISRCTN58830535
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Source(s) of Monetary Support
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Health Insurance Company Nuts Ohra
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