|- candidate number||8493|
|- NTR Number||NTR2534|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-sep-2010|
|- Secondary IDs||10/135 METC UMCU|
|- Public Title||IMProving Adherence in chronic hepatitis C patients on peg-interferon - ribavirin combination Therapy.|
|- Scientific Title||IMProving Adherence in chronic hepatitis C patients on peg-interferon - ribavirin combination Therapy.|
|- hypothesis||The Sensemedic system with SMS reminders can improve adherence to ribavirin in chronic hepatitis C patients on peg-interferon and ribavirin treatment. |
|- Healt Condition(s) or Problem(s) studied||Hepatitis C, Compliance|
|- Inclusion criteria||1. CHC patients eligible for antiviral treatment with PEG-interferon and ribavirin (PegIntron®/ Rebetol®);|
2. 18 years of age or older;
4. Good understanding of Dutch language;
5. Use of mobile phone;
6. Obtained informed consent.
|- Exclusion criteria||Contra-indications for antiviral treatment.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2010|
|- planned closingdate||1-okt-2011|
|- Target number of participants||100|
|- Interventions||Sensemedic system: A medication dispenser which registers intake behaviour of the patients in real time and sends a SMS reminder in case no signal is received. Patients in the intervention group receive tje Sensemedic system, patients in the control group receive standard-of-care. |
|- Primary outcome||Adherence (<80% vs. ≥80%), measured by pill counts.|
|- Secondary outcome||1. Adherence data in intervention group:|
A. No. of missed doses;
B. No. of days without any dose;
C. % of doses in prespecified time frame (2hrs in morning and evening).
2. Plasma ribavirin concentrations (week 8 and 24);
3. Virological response: RVR, EVR, week-24 response;
4. Food composition (in subgroup of patients).
|- Timepoints||Weeks 4, 8, 12, 16, 20, 24.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. K.J. Erpecum, van|
|- CONTACT for SCIENTIFIC QUERIES||MD. L.G. Vlerken, van|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU)|
|- Brief summary||Rationale: |
Chronic hepatitis C leads to significant morbidity and mortality, as well as decreased quality of life. Unfortunately, current treatment consisting of PEG-interferon and ribavirin is not effective in 20-50% of cases, depending in part on hepatitis C virus genotype. We hypothesize that differences in patients’ adherence to antiviral treatment are also associated with differences in treatment response. Real-Time Medication Monitoring (RTMM) uses an electronic medication dispenser (Sensemedic) which monitors patients’ medication intake in real time, and in case of incorrect use, the patient receives a SMS reminder. The effect of RTMM on drug adherence is currently studied in patients with chronic diseases, such as diabetes mellitus and hypertension, with promising initial results.
To study the influence of the Sensemedic system with SMS reminders on adherence to ribavirin in chronic hepatitis C patients on PEG-interferon and ribavirin treatment.
Chronic hepatitis C patients eligible for antiviral treatment with PEG-interferon and ribavirin.
Randomized, open-label, multi-centre trial including 100 chronic hepatitis C patients. Patients will be randomly assigned in equal proportions to either the intervention group or control group, stratified for intravenous drug use and treatment centre. Patients will be asked to complete a questionnaire on quality of life and satisfaction with the Sensemedic system (if applicable) twice, resp. once during treatment. Furthermore, a subgroup of patients will be asked to complete a food diary twice during treatment.
Patients in the intervention group will receive the Sensemedic medication dispenser and will receive a text message in the case of incorrect medication use. Patients in the control group will receive standard-of-care.
Main study parameters/endpoints:
The main study parameter is adherence, as measured by 4-weekly pill counts in both patient groups. In addition, in the intervention group, analysis of real time adherence data will provide more detailed adherence information (no. of missed doses, no. of days without any dose, % of doses in prespecified time frame).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The risk of participation in the current study is considered to be negligible compared to antiviral treatment outside this study protocol, since treatment in the study does not differ from current practice. Patients in the intervention group may have a higher chance of reaching SVR if suboptimal adherence can be increased by receiving text messages in case of incorrect use. There is no need to bring an additional visit to the hospital, and no extra venepuncture has to be performed. Patients will be asked to complete a questionnaire on quality of life and satisfaction with the Sensemedic system (if applicable) twice resp. once during treatment. Furthermore, a subgroup of patients will be asked to complete a food diary twice during treatment.
|- Main changes (audit trail)|
|- RECORD||24-sep-2010 - 8-okt-2010|