IMProving Adherence in chronic hepatitis C patients on peg-interferon - ribavirin combination Therapy.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28744

Enrollment

100

Registered

2010-09-24

Start date

2010-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

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 recei

Eligibility

Inclusion criteria

Inclusion criteria: 1. CHC patients eligible for antiviral treatment with PEG-interferon and ribavirin (PegIntron®/ Rebetol®); 2. 18 years of age or older; 3. Mobile; 4. Good understanding of Dutch language; 5. Use of mobile phone; 6. Obtained informed consent.

Exclusion criteria

Exclusion criteria: Contra-indications for antiviral treatment.

Design outcomes

Primary

Measure	Time frame
Adherence (<80% vs. ≥80%), measured by pill counts.	—

Secondary

Measure	Time frame
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).	—

Contacts

Public ContactK.J. Erpecum, van

University Medical Center Utrecht (UMCU), F02.618, P.O. Box 85500

K.J.vanerpecum@AZU.NL

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)