CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 113 enrolled
Drug / intervention
Reminders, habit-based strategies and/or involvement of family member +4 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT04023734
NCT04023734N/ACompleted

A Targeted and Tailored Pharmacist Intervention to Improve Adherence to Antihypertensive Drugs Among Patients With Diabetes in Indonesia: a Cluster Randomized Controlled Trial

University of Groningen·interventional·Posted Jul 17, 2019·Updated Mar 24, 2020

In Brief

A clinical study evaluating Reminders, habit-based strategies and/or involvement of family member, Counselling to increase knowledge, and 3 other interventions for Diabetes Mellitus, Type 2 and 2 related conditions. Completed, enrolled 113 participants across 1 site.

Detailed Summary

The primary objective of this study is to assess the effect of a targeted and tailored pharmacist intervention on medication adherence among diabetes patients non-adherent to antihypertensive drugs. The secondary objectives are to assess the effect of the intervention on blood pressure level and medication beliefs, and to evaluate the implementation and adoption of the intervention for pharmacists and patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndonesia

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 17, 2019
Enrollment StartAug 16, 2019
Primary CompletionDec 30, 2019
Study CompletionJan 30, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.0 years ago

Interventions

Reminders, habit-based strategies and/or involvement of family memberbehavioral

Strategies to cope with forgetfulness include reminders, habit-based strategies and/or involvement of family members. The use of a reminder tool and pill boxes will be encouraged and a reminder app can be implemented if patients own a mobile phone. The habit-based strategy will be delivered through a printed worksheet which is tailored to patient's daily routine. Patients will be asked to identify the appropriate place and time to take their medication, and an action they conduct every day that could serve as a prompt or cue to take their medication. Patients will be asked to write coping plans to formulate their own "if-then" plans for all daily doses of their antihypertensive drug(s). Moreover, patients will be asked to choose a family member to become their treatment supporter. This individual will be asked to support patients to take the antihypertensive drugs. Pharmacists will remind patients to take his/her completed worksheet to the next visit.

Counselling to increase knowledgebehavioral

The content of the counselling to cope with lack of knowledge will focus on educating patients about the purpose of the medication, when and how to take the medication, the need for long-term use, the importance of medication adherence, and how to deal with possible side effects. To explore which education is needed, the patient will be asked whether they know why and how to take their medication. The teach-back method will be used, where the patient is asked to explain the pharmacist what he/she has understood after receiving the education.

Counselling to increase motivationbehavioral

The content of the counselling to cope with lack of motivation will focus on exploring and discussing their concerns and necessity beliefs. This method is called motivational interviewing. This is done by asking a first question about whether the medication bothers the patient. Follow-up on this question can focus on any concerns or low necessity beliefs (e.g., when patients are bothered by the medication because they think the medication is not needed or are afraid of side-effects).

Explore/address other drug related problemsbehavioral

The content of the counselling to address other drug related problems will focus on exploring these other problems underlying the non-adherence, for example experiencing side effects, costs, polypharmacy, difficulty to refill antihypertensive drugs in time, or medication intake problems, and offering solutions/alternatives when possible.

Usual care based on the Indonesian guidelinebehavioral

Patients in five CHCs randomized to the control group will receive pharmacist counselling based on the Indonesian guideline of pharmacy practice. At each visit, they will receive information about the quantity and dose of the dispensed drugs, when and how to use and store the drugs, side effects and how to deal with them, the importance of medication adherence, and confirming if the patient understands how to take medications correctly.