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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24491

Enrollment

4400

Registered

2012-01-13

Start date

2011-04-01

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

compliance, adherence, persistence, statins, bisphosphonates, antidepressants, RAS-inhibitors, BMQ, beliefs, SIMS

Interventions

A 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 th

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
The 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.	—

Measure

Time frame

The 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.

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Secondary

Measure	Time frame
The 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.	—

Contacts

Public ContactM.J. Kooij

Department Pharmaceutical Sciences Utrecht University Universiteitsweg 99 P.O Box 80082

m.j.kooij@uu.nl+31 (0)30 2537324

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)