Group training for hepatitis C patients to improve quality of life
| ISRCTN | ISRCTN58830535 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58830535 |
| Protocol serial number | NL920 (NTR944) |
| Sponsor | Erasmus Medical Centre (The Netherlands) |
| Funder | Health Insurance Company Nuts Ohra (Stichting Nuts Ohra) (The Netherlands) |
- Submission date
- 02/05/2007
- Registration date
- 02/05/2007
- Last edited
- 23/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms A. Beerthuizen
Scientific
Scientific
Erasmus Medical Centre
Department of Psychiatry and Psychotherapy
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 408 8234 |
|---|---|
| a.beerthuizen@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, parallel group, multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Group training for hepatitis C patients to improve quality of life |
| Study acronym | Intervention for hepatitis C patients |
| Study objectives | Problem solving therapy improves the quality of life in patients with hepatitis C. |
| Ethics approval(s) | Approval received from the Medical Ethical Board of the Erasmus MC on the 22nd of February 2007 (ref: MEC-2007-001). |
| Health condition(s) or problem(s) studied | Hepatitis C patients' quality of life |
| Intervention | 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 eight sessions of two 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 six months after the training. When the intervention is effective, controls will participate in this training after the end of this research project. |
| Intervention type | Other |
| Primary outcome measure(s) | Quality of life (36-item Short Form [SF-36] questionnaire); the participants will complete this questionnaire at baseline, T1 (right after the training) and at T2 (six months after the last session of the training). |
| Key secondary outcome measure(s) | 1. Health status (European Quality of Life [EuroQoL-5D] questionnaire) 2. Health & Labour Questionnaire 3. Depression (Beck Depression Inventory [BDI]) 4. 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). |
| Completion date | 31/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. Hepatitis C 2. Age 18 years or older |
| Key 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 |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 31/08/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
23/09/2021: Proactive update review. No publications found. Search options exhausted.
