Effectiveness of patient support programme for the treatment of hepatitis C
| ISRCTN | ISRCTN12471415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12471415 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/05/2006
- Registration date
- 02/06/2006
- Last edited
- 25/09/2009
- 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
Dr Shin-Hai Tsai
Scientific
Scientific
Number 250 Wu-Xing Street
TAIPEI
110
Taiwan
Study information
| Study design | Interventional randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Since there is no hepatitis C vaccine available for primary prevention, health education is the most important control strategy in containing the impact of hepatitis C. The hypothesis of this study is that effective patient support programs could improve the compliance to treatment and outcome of hepatitis C patients. |
| Ethics approval(s) | The institutional review board approved the protocol and all patients provided a written informed consent. The date and reference number of ethical approval for our trial is 10/10/2004 and F-950208. |
| Health condition(s) or problem(s) studied | Chronic hepatitis C |
| Intervention | All patients who met these criteria randomly chose to be serviced in either of the following two groups: Group 1 with public health nurse consultation in the outpatient clinic. Group 2 was offered phone consultation via a health communication center whenever patients needed. Trained healthcare professionals including four nurses and one physician backup at the communication center made a series of structured, scheduled supportive phone calls to patients throughout their treatment period. Additional support was offered to patients to call the healthcare professionals at any time if they have questions. Treating physicians were notified periodically by the health communication center through built-in standardized reminder forms. All patients were treated with standard therapy. Patients were followed up for 72 weeks. Demographic, laboratory, adverse events, dropout rate and cost data were collected and analyzed. |
| Intervention type | Other |
| Primary outcome measure | Sustained virologic response (absence of detectable HCV RNA at the end of follow-up with PCR assay) |
| Secondary outcome measures | 1. Serum alanine aminotransferase 2. Aspartate aminotransferase 3. Dropout rate (the number of patients who discontinued treatment prematurely or were lost to follow-up) |
| Overall study start date | 01/01/2004 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 500 |
| Key inclusion criteria | Adult patients who have never received interferon and who had at least 2000 copies of HCV ribonucleic acid per ml (RNA/ml) of serum with polymerase chain reaction (PCR) assay, serum aspartate aminotransferase (AST) above the upper limit of normal within six months before entry into study and a liver biopsy result consistent with the diagnosis of chronic hepatitis C. |
| Key exclusion criteria | Patients with: 1. Neutropenia (<1500/ml of neutrophils) 2. Anemia (Hb <12g/dl of hemoglobin) 3. Thrombocytopenia (platelet <90000/ml) 4. Human immunodeficiency virus (HIV) infection 5. Decompensated liver disease 6. Serum creatinine >1.5 times the upper limit of normal 7. Poorly-controlled psychiatric disease 8. Unwilling to receive contraception |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 30/06/2005 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Number 250 Wu-Xing Street
TAIPEI
110
Taiwan
110
Taiwan
Sponsor information
Department of Health (Taiwan)
Government
Government
Number 100 Aiguo E. Road
Jhongjheng District
Taipei
10092
Taiwan
| Website | http://www.doh.gov.tw |
|---|---|
"ROR" |
https://ror.org/0225asj53 |
Funders
Funder type
Government
Department of Health (Taiwan) (ref: DOH94-TD-B-111-002)
No information available
National Health Research Institute (Taiwan) (ref: NHRI-EX95-9106PN)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
