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Effects of telephone counseling intervention by pharmacist on medication adherence for patients starting treatment: A cluster randomized controlled trial.


- candidate number10926
- NTR NumberNTR3237
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jan-2012
- Secondary IDsUP1019 Institutional Review Board (IRB)
- Public TitleEffects of telephone counseling intervention by pharmacist on medication adherence for patients starting treatment: A cluster randomized controlled trial.
- Scientific TitleEffects of telephone counseling intervention by pharmacist on medication adherence for patients starting treatment: A cluster randomized controlled trial.
- ACRONYMTelCIP
- hypothesisPrescription of medication is the most common intervention in health care. Adherence to medication is often low. Non-adherence to long-term therapies severely compromises the effectiveness of treatment and thereby is a critical issue from both the perspective of quality of life of individual patients and from a public health perspective. Interventions aimed at improving adherence could increase both the effectiveness of medication and prevent the occurrence of adverse health outcomes. Counselling by telephone is a promising intervention to deliver patient-tailored care. In this study the effects of a counselling call at the start of the therapy will be investigated.
- Healt Condition(s) or Problem(s) studiedCompliance, Compliance, Statin, Bisfosfonates, Antidepressants, SIMS, BMQ, RAS-inhibitors, Persistence
- Inclusion criteria1. Age over 18 years;
2. In posession of telephone;
3. Responsible for medication taking;
4. Receiving a first prescription in 12 months for a statin (C10), RAS-inhibitor (C09), Bisphosphonate (M05B) or antidepressant (N06A).
- Exclusion criteria1. Life expectancy of less than 6 months;
2. Receiving medication weekly (e.g. automated dispensing);
3. Not speaking the language of the pharmacist;
4. Not having a telephone.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2011
- planned closingdate1-mei-2013
- Target number of participants4400
- InterventionsA trained pharmacist or pharmacy technician calls patients by between 1 and 3 weeks after the start of therapy. The main purpose of this call is to evaluate the first two weeks, to explore factors that can negatively influence therapy, like drug related problems, beliefs or attitudes.
- Primary outcomeThe primary outcomes measured are taking-compliance measured over 365 days and the occurrence of complete discontinuation. Taking-compliance will be based on refill data and will be expressed as Proportion of days covered over a period of 365 days (12 months PDC). Differences in median proportion of days covered will be tested using the non-parametric Mann Whitney U test and the percentage of adherent patients between groups will be analyzed with χ2-test. Complete discontinuation will be defined as exceeding the permissible gap of 90 days within the one year observation period. Cox-proportional hazards will be used to compare discontinuation between intervention and control patients.
- Secondary outcomeThe occurence of early discontinuation after 3 and 6 months. Score on the Beliefs about Medicines Questionnaire (BMQ) and Satisfaction with Information about Medicines Scale (SIMS) after 3 months.
- TimepointsCompliance and persistence will be assessed 12 months after the start of the therapie. Beliefs (BMQ) and satisfaction (SIMS) will be assessed 3 months after the start.
- Trial web sitewww.startconsult.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.J. Kooij
- CONTACT for SCIENTIFIC QUERIES M.J. Kooij
- Sponsor/Initiator Utrecht Institute for Pharmaceutical Sciences, Utrecht University
- Funding
(Source(s) of Monetary or Material Support)
Utrecht Institute for Pharmaceutical Sciences, Utrecht University
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD13-jan-2012 - 29-jan-2012


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