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Group training for hepatitis C patients to improve quality of life.


- candidate number2535
- NTR NumberNTR944
- ISRCTNISRCTN58830535
- Date ISRCTN created2-mei-2007
- date ISRCTN requested20-apr-2007
- Date Registered NTR29-mrt-2007
- Secondary IDs 
- Public TitleGroup training for hepatitis C patients to improve quality of life.
- Scientific TitleGroup training for hepatitis C patients to improve quality of life.
- ACRONYMIntervention for hepatitis C patients
- hypothesisProblem solving therapy improves the quality of life in patients with hepatitis C
- Healt Condition(s) or Problem(s) studiedHepatitis C, Intervention, Quality of life, Psychosocial
- Inclusion criteria1. Hepatitis C; 2. Age 18 years or older
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-mrt-2007
- planned closingdate31-aug-2008
- Target number of participants300
- Interventions150 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.
- Primary outcomeQuality 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)
- Secondary outcomeHealth 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).
- Timepoints
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A. Beerthuizen
- CONTACT for SCIENTIFIC QUERIESDr A. Spijker, van 't
- Sponsor/Initiator Erasmus Medical Center, Department of Medical Psychology and Psychotherapy
- Funding
(Source(s) of Monetary or Material Support)
Health Insurance Company Nuts Ohra
- PublicationsThe results will be published in international scientific journals
- Brief summaryPatients who do not (yet) receive treatment, or who do not respond to treatment with Interferon participate in a group intervention to improving their problem solving abilities
- Main changes (audit trail)
- RECORD29-mrt-2007 - 7-mei-2007


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl