Diabetes Mellitus, Type 2NCT04023734
A Targeted and Tailored Pharmacist Intervention to Improve Adherence to Antihypertensive Drugs Among Diabetes Patients
A study testing Reminders, habit-based strategies and/or involvement of family member, Counselling to increase knowledge and Counselling to increase motivation in people with Diabetes Mellitus, Type 2 and Hypertension, run by University of Groningen at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension, Medication Nonadherence
- What is being tested?
- Reminders, habit-based strategies and/or involvement of family member, Counselling to increase knowledge and Counselling to increase motivation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Aug 2019to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- Diagnosed with type 2 diabetes for at least one year based on patient's medical record.
- Using at least one antihypertensive drug in the last three months.
- Provision of signed informed consent.
- Have sub-optimal medication adherence to antihypertensive drugs according to the MARS (<20).
Who cannot join
- Patients with severe mental or physical constraints.
- Pregnancy or in the lactation period.
- Illiterate in Indonesian language.
- Enrollment in another intervention study.
- Those not responsible for taking their own medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Targeted and Tailored Pharmacist Intervention to Improve Adherence to Antihypertensive Drugs Among Patients With Diabetes in Indonesia: a Cluster Randomized Controlled Trial
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.
Read the detailed description
Adherence to chronic medication is often suboptimal. However, existing interventions to improve adherence are either too complex or expensive for implementation and scale-up in low-middle income countries and/or not particularly effective.
A cluster randomized controlled trial with 3-months follow-up will be conducted in 10 Community Health Centers (CHCs) in Indonesia. Patients aged ≥18 years, diagnosed with type 2 diabetes and reported non-adherence to antihypertensive drugs according to the Medication Adherence Report Scale (MARS) are eligible to participate. Patients in the five CHCs randomized to the intervention group will receive a targeted and tailored pharmacist intervention at baseline (first session) and at 1-month follow-up (second session). The intervention will be low-cost, align with the current CHC workflow and will not require a substantial change to the current system. Before dispensing antihypertensive drugs during the first session, the pharmacist will discuss patient-specific barrier(s) for medication adherence based on their responses on MARS and three additional questions, which are derived from the Brief Medication Questionnaires. The intervention strategies will then be tailored to their identified adherence problems. Based on current literature, the investigators defined four non-adherence problems that can be addressed by the community pharmacist, i.e. (1) forgetfulness, (2) lack of knowledge, (3) lack of motivation or (4) other drug-related problems. Of note, patients might need a combined intervention strategy to address all experienced problems. The four non-adherence problems and recommended intervention strategies are specified below:
- Strategies to cope with forgetfulness include reminders, habit-based strategies and/or involvement of family members.
- The content of the counselling to cope with lack of knowledge will focus on educating patients about 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.
- The content of the counselling to cope with lack of motivation will focus on exploring and discussing the patients' concerns and necessity beliefs (motivational interviewing).
- The content of the counselling to address other drug related problems will focus on exploring 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.
The follow-up session will be conducted in one month after the baseline session, when patients refill their medication at the next regular outpatient visit. The purpose of the follow-up session is (1) to evaluate the short-term effect of the intervention and discuss the patients' implementation of and experiences with the offered information and recommendations, and (2) to address non-adherence problems that were not yet addressed during the first session. Where needed, the pharmacist, together with patient, can make changes to the coping plan and discuss additional interventions. As the quality of the intervention will depend on the competences and skills of the pharmacist, treatment integrity will be enhanced by an obligatory communication training focusing on motivational interviewing and the teach-back method, and by providing supportive material as part of the intervention.
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 can 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. Patients in the control group will complete all assessments at the same time points as those in the intervention group
The primary study outcome is the difference between intervention and control group in change in total adherence scores using the MARS between baseline and 3 months follow-up. Secondary outcomes are blood pressure (BP), medication beliefs using the Beliefs about Medicines Questionnaire (BMQ)-specific, and evaluate the intervention using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance).
- Being tested
- Reminders, habit-based strategies and/or involvement of family member, Counselling to increase knowledge, Counselling to increase motivation, Explore/address other drug related problems, Usual care based on the Indonesian guideline
- Keywords
- Medication non-adherence, Type 2 diabetes, Antihypertensive agents
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminders, habit-based strategies and/or involvement of family memberBehavioural
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 knowledgeBehavioural
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 motivationBehavioural
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 problemsBehavioural
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 guidelineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A targeted and tailored pharmacist intervention at baseline and at 1-month follow-up. Receives: Behavioral: Reminders, habit-based strategies and/or involvement of family member; Behavioral: Counselling to increase knowledge; Behavioral: Counselling to increase motivation; Behavioral: Explore/address other drug related problems |
| Control group | Active comparator | Usual care based on the Indonesian guideline at baseline and 1-month follow-up. Receives: Behavioral: Usual care based on the Indonesian guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
The differences in change in total score of medication adherence using Medication Adherence Report Scale (MARS). The Indonesian version of the MARS showed to be valid (correlation value of each question to the total score > 0.396) and reliable (Cronbach α coefficient of 0.803). Patients will indicate how often each statement applied to them on a 5-point Likert scale ranging from always (score 1) to never (score 5). Items are summed to obtain a total score ranging from 5 to 25.
Measured: Baseline, 1-month, and 3-month follow-up
Secondary outcomes (9)
Blood pressure level
Within and between patient changes in blood pressure (BP) level (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) at baseline, 1-month, and 3-month follow-up. BP measurements will be performed by a nurse who is blinded to the group assignment.
Measured: Baseline, 1-month, and 3-month follow-up
Medication beliefs
Within patient changes on beliefs about medication will be assessed using the BMQ-specific at baseline and 3-month follow-up. The BMQ-specific contains 5 items about necessity beliefs (e.g. "My health at present depends on my blood pressure-lowering medicines"), and 5 items about concern beliefs (e.g. "I sometimes worry about becoming too dependent on my blood pressure-lowering medicines"). All items have a 5-point Likert scale ranging from strongly disagree to strongly agree with an overall range from 5 (low necessity, low concern) to 25 (high necessity, high concern). A necessity-concern differential score will be calculated by subtracting the scores of the concerns scale from the necessity scale (range -20 to 20). A positive differential score indicates stronger beliefs in the necessity, while a negative score indicates stronger concerns.
Measured: Baseline and 3-month follow-up
Reach
Reach will be assessed by measuring the participation rates and representativeness of patients who participate in this study. In case a patient refuses or discontinues to participate in this study, patient's age, gender, and BP lowering drugs the patient uses will be recorded by research assistants. This information is used to calculate the participation rate and assess differences between responders and non-responders. To determine representativeness, patient's demographics will be compared to census demographics in Bandung City, Indonesia.
Measured: On completion of the final assessments at 3-month follow-up.
Pharmacists' adoption of the intervention
Pharmacists' adoption with various parts of the intervention will be assessed by focus group discussion (FGD). Example of questions:
- What do you think of the program in general?(Regarding number of sessions, time between sessions, duration of sessions)
- Tell me about positive experiences you have had with the program. Do others agree? Do others have different experiences?
- Tell me about negative experiences you have had with the program. Do others agree? Do others have different experiences?
Measured: On completion of the final assessments at 1-month follow-up.
Patients' adoption of the intervention
Patients' adoption with various parts of the intervention will be assessed by a questionnaire (e.g How satisfied are you with the information provided by the pharmacist regarding your antihypertensive drugs during the past three months?)
Measured: On completion of the final assessments at 3-month follow-up.
Pharmacists' suggestions for future implementation
Pharmacists' suggestions for future implementation of the intervention will be assessed by FGD with following questions:
- Suppose that you were in charge, do you think this program could be implemented in your CHC?
- Please explain why or why not.
- What do others think?
- What do you see as barriers?
- What would help to support the implementation?
Measured: On completion of the final assessments at 1-month follow-up.
Patients' suggestions for future implementation
Patients' suggestions for future implementation of the intervention will be assessed by a questionnaire (e.g How could we improve the program?)
Measured: On completion of the final assessments at 3-month follow-up.
Pharmacists' willingness to maintain the intervention
Pharmacists' willingness to continue the intervention as part of routine clinical practice over the long term will be assessed by FGD with the following questions:
- Suppose that this program is implemented, do you think this program will sustain in your CHC? - Please explain why or why not.
- What do others think?
- What do you see as barriers?
- What would help to sustain this program?
Measured: On completion of the final assessments at 1-month follow-up.
Patients' willingness to maintain the intervention
Patients' willingness to continue the intervention as part of routine clinical practice over the long term will be assessed by a questionnaire (e.g Suppose that this program will be implemented in the future, how often would you like to receive it?)
Measured: On completion of the final assessments at 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start16 Aug 2019
- Primary completion30 Dec 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Padjadjaran
- Responsible party
- Principal investigator, Sofa Dewi Alfian, University of Groningen
- Investigators
- Sofa D Alfian, Principal investigator, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023734
- Sponsor's protocol ID
- PharIndo2019
- Status last verified
- Mar 2020
- First submitted
- 26 Jun 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers may contact the principal investigator (s.d.alfian@rug.nl)
Publications
Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, Agoritsas T, Mistry N, Iorio A, Jack S, Sivaramalingam B, Iserman E, Mustafa RA, Jedraszewski D, Cotoi C, Haynes RB. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2014 Nov 20;2014(11):CD000011. doi: 10.1002/14651858.CD000011.pub4.
PubMed 25412402Kini V, Ho PM. Interventions to Improve Medication Adherence: A Review. JAMA. 2018 Dec 18;320(23):2461-2473. doi: 10.1001/jama.2018.19271.
PubMed 30561486Cutrona SL, Choudhry NK, Fischer MA, Servi AD, Stedman M, Liberman JN, Brennan TA, Shrank WH. Targeting cardiovascular medication adherence interventions. J Am Pharm Assoc (2003). 2012 May-Jun;52(3):381-97. doi: 10.1331/JAPhA.2012.10211.
PubMed 22618980van Boven JF, Stuurman-Bieze AG, Hiddink EG, Postma MJ, Vegter S. Medication monitoring and optimization: a targeted pharmacist program for effective and cost-effective improvement of chronic therapy adherence. J Manag Care Spec Pharm. 2014 Aug;20(8):786-92. doi: 10.18553/jmcp.2014.20.8.786.
PubMed 25062071Wroe AL. Intentional and unintentional nonadherence: a study of decision making. J Behav Med. 2002 Aug;25(4):355-72. doi: 10.1023/a:1015866415552.
PubMed 12136497Clifford S, Barber N, Horne R. Understanding different beliefs held by adherers, unintentional nonadherers, and intentional nonadherers: application of the Necessity-Concerns Framework. J Psychosom Res. 2008 Jan;64(1):41-6. doi: 10.1016/j.jpsychores.2007.05.004.
PubMed 18157998Alfian SD, Abdulah R, Denig P, van Boven JFM, Hak E. Targeted and tailored pharmacist-led intervention to improve adherence to antihypertensive drugs among patients with type 2 diabetes in Indonesia: study protocol of a cluster randomised controlled trial. BMJ Open. 2020 Jan 6;10(1):e034507. doi: 10.1136/bmjopen-2019-034507.
PubMed 31911526
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Targeted and Tailored Pharmacist Intervention to Improve Adherence to Antihypertensive Drugs Among Patients With Diabetes in Indonesia: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04023734
- Acronym / sponsor ID
- PharIndo2019
- Keywords
- Medication non-adherence, Type 2 diabetes, Antihypertensive agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Collaborators
- Universitas Padjadjaran
- Study start
- 16 Aug 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adherence to chronic medication is often suboptimal. However, existing interventions to improve adherence are either too complex or expensive for implementation and scale-up in low-middle income countries and/or not particularly effective.
A cluster randomized controlled trial with 3-months follow-up will be conducted in 10 Community Health Centers (CHCs) in Indonesia. Patients aged ≥18 years, diagnosed with type 2 diabetes and reported non-adherence to antihypertensive drugs according to the Medication Adherence Report Scale (MARS) are eligible to participate. Patients in the five CHCs randomized to the intervention group will receive a targeted and tailored pharmacist intervention at baseline (first session) and at 1-month follow-up (second session). The intervention will be low-cost, align with the current CHC workflow and will not require a substantial change to the current system. Before dispensing antihypertensive drugs during the first session, the pharmacist will discuss patient-specific barrier(s) for medication adherence based on their responses on MARS and three additional questions, which are derived from the Brief Medication Questionnaires. The intervention strategies will then be tailored to their identified adherence problems. Based on current literature, the investigators defined four non-adherence problems that can be addressed by the community pharmacist, i.e. (1) forgetfulness, (2) lack of knowledge, (3) lack of motivation or (4) other drug-related problems. Of note, patients might need a combined intervention strategy to address all experienced problems. The four non-adherence problems and recommended intervention strategies are specified below:
- Strategies to cope with forgetfulness include reminders, habit-based strategies and/or involvement of family members.
- The content of the counselling to cope with lack of knowledge will focus on educating patients about 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.
- The content of the counselling to cope with lack of motivation will focus on exploring and discussing the patients' concerns and necessity beliefs (motivational interviewing).
- The content of the counselling to address other drug related problems will focus on exploring 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.
The follow-up session will be conducted in one month after the baseline session, when patients refill their medication at the next regular outpatient visit. The purpose of the follow-up session is (1) to evaluate the short-term effect of the intervention and discuss the patients' implementation of and experiences with the offered information and recommendations, and (2) to address non-adherence problems that were not yet addressed during the first session. Where needed, the pharmacist, together with patient, can make changes to the coping plan and discuss additional interventions. As the quality of the intervention will depend on the competences and skills of the pharmacist, treatment integrity will be enhanced by an obligatory communication training focusing on motivational interviewing and the teach-back method, and by providing supportive material as part of the intervention.
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 can 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. Patients in the control group will complete all assessments at the same time points as those in the intervention group
The primary study outcome is the difference between intervention and control group in change in total adherence scores using the MARS between baseline and 3 months follow-up. Secondary outcomes are blood pressure (BP), medication beliefs using the Beliefs about Medicines Questionnaire (BMQ)-specific, and evaluate the intervention using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Reminders, habit-based strategies and/or involvement of family member, Behavioral: Counselling to increase knowledge, Behavioral: Counselling to increase motivation, Behavioral: Explore/address other drug related problemsA targeted and tailored pharmacist intervention at baseline and at 1-month follow-up. |
| Control group | Active comparator | Behavioral: Usual care based on the Indonesian guidelineUsual care based on the Indonesian guideline at baseline and 1-month follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old.
- Diagnosed with type 2 diabetes for at least one year based on patient's medical record.
- Using at least one antihypertensive drug in the last three months.
- Provision of signed informed consent.
- Have sub-optimal medication adherence to antihypertensive drugs according to the MARS (<20).
Key exclusion criteria (5 listed)
- Patients with severe mental or physical constraints.
- Pregnancy or in the lactation period.
- Illiterate in Indonesian language.
- Enrollment in another intervention study.
- Those not responsible for taking their own medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reminders, habit-based strategies and/or involvement of family memberStrategies 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. | Behavioural | Intervention |
| Counselling to increase knowledgeThe 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. | Behavioural | Intervention |
| Counselling to increase motivationThe 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). | Behavioural | Intervention |
| Explore/address other drug related problemsThe 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. | Behavioural | Intervention |
| Usual care based on the Indonesian guidelinePatients 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. | Behavioural | Control group |
Primary outcome
Medication adherence
Time frame: Baseline, 1-month, and 3-month follow-up
The differences in change in total score of medication adherence using Medication Adherence Report Scale (MARS). The Indonesian version of the MARS showed to be valid (correlation value of each question to the total score > 0.396) and reliable (Cronbach α coefficient of 0.803). Patients will indicate how often each statement applied to them on a 5-point Likert scale ranging from always (score 1) to never (score 5). Items are summed to obtain a total score ranging from 5 to 25.
9 secondary outcomes
Blood pressure level
Time frame: Baseline, 1-month, and 3-month follow-up
Medication beliefs
Time frame: Baseline and 3-month follow-up
Reach
Time frame: On completion of the final assessments at 3-month follow-up.
Pharmacists' adoption of the intervention
Time frame: On completion of the final assessments at 1-month follow-up.
Patients' adoption of the intervention
Time frame: On completion of the final assessments at 3-month follow-up.
Pharmacists' suggestions for future implementation
Time frame: On completion of the final assessments at 1-month follow-up.
Patients' suggestions for future implementation
Time frame: On completion of the final assessments at 3-month follow-up.
Pharmacists' willingness to maintain the intervention
Time frame: On completion of the final assessments at 1-month follow-up.
Patients' willingness to maintain the intervention
Time frame: On completion of the final assessments at 3-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Background: PubMed 25412402Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, Agoritsas T, Mistry N, Iorio A, Jack S, Sivaramalingam B, Iserman E, Mustafa RA, Jedraszewski D, Cotoi C, Haynes RB. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2014 Nov 20;2014(11):CD000011. doi: 10.1002/14651858.CD000011.pub4.
- Background: PubMed 30561486Kini V, Ho PM. Interventions to Improve Medication Adherence: A Review. JAMA. 2018 Dec 18;320(23):2461-2473. doi: 10.1001/jama.2018.19271.
- Background: PubMed 22618980Cutrona SL, Choudhry NK, Fischer MA, Servi AD, Stedman M, Liberman JN, Brennan TA, Shrank WH. Targeting cardiovascular medication adherence interventions. J Am Pharm Assoc (2003). 2012 May-Jun;52(3):381-97. doi: 10.1331/JAPhA.2012.10211.
- Background: PubMed 25062071van Boven JF, Stuurman-Bieze AG, Hiddink EG, Postma MJ, Vegter S. Medication monitoring and optimization: a targeted pharmacist program for effective and cost-effective improvement of chronic therapy adherence. J Manag Care Spec Pharm. 2014 Aug;20(8):786-92. doi: 10.18553/jmcp.2014.20.8.786.
- Background: PubMed 12136497Wroe AL. Intentional and unintentional nonadherence: a study of decision making. J Behav Med. 2002 Aug;25(4):355-72. doi: 10.1023/a:1015866415552.
- Background: PubMed 18157998Clifford S, Barber N, Horne R. Understanding different beliefs held by adherers, unintentional nonadherers, and intentional nonadherers: application of the Necessity-Concerns Framework. J Psychosom Res. 2008 Jan;64(1):41-6. doi: 10.1016/j.jpsychores.2007.05.004.
- Derived from this study: PubMed 31911526Alfian SD, Abdulah R, Denig P, van Boven JFM, Hak E. Targeted and tailored pharmacist-led intervention to improve adherence to antihypertensive drugs among patients with type 2 diabetes in Indonesia: study protocol of a cluster randomised controlled trial. BMJ Open. 2020 Jan 6;10(1):e034507. doi: 10.1136/bmjopen-2019-034507.
- Individual participant dataSharing planned: No. Other researchers may contact the principal investigator (s.d.alfian@rug.nl)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofa D Alfian principal investigator
University of Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminders, habit-based strategies and/or involvement of family member, Counselling to increase knowledge and Counselling to increase motivation in people with Diabetes Mellitus, Type 2 and Hypertension, run by University of Groningen at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: Baseline, 1-month, and 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04023734, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.