A Targeted and Tailored Pharmacist Intervention to Improve Adherence to Antihypertensive Drugs Among Diabetes Patients

NCT04023734 | Completed

• 1 other identifier: PharIndo2019
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Hypertension; Medication Nonadherence

Keywords

Medication non-adherence; Type 2 diabetes; Antihypertensive agents

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1-month, and 3-month follow-up

Secondary Outcomes (9)

• Blood pressure level

  Baseline, 1-month, and 3-month follow-up

• Medication beliefs

  Baseline and 3-month follow-up

• Reach

  On completion of the final assessments at 3-month follow-up.

• Pharmacists' adoption of the intervention

  On completion of the final assessments at 1-month follow-up.

• Patients' adoption of the intervention

  On completion of the final assessments at 3-month follow-up.

Study Arms (2)

Intervention

EXPERIMENTAL

A targeted and tailored pharmacist intervention at baseline and at 1-month follow-up.

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.

Behavioral: Usual care based on the Indonesian guideline

Interventions

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

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.

Intervention

Counselling to increase knowledge BEHAVIORAL

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.

Intervention

Counselling to increase motivation BEHAVIORAL

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).

Intervention

Explore/address other drug related problems BEHAVIORAL

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.

Intervention

Usual care based on the Indonesian guideline BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Groningen: lead
• Universitas Padjadjaran: collaborator

Study Sites (1)

Community Health Centers

Bandung, West Java, Indonesia

Location

Related Publications (7)

• 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.

  PMID: 25412402 BACKGROUND

• Kini V, Ho PM. Interventions to Improve Medication Adherence: A Review. JAMA. 2018 Dec 18;320(23):2461-2473. doi: 10.1001/jama.2018.19271.

  PMID: 30561486 BACKGROUND

• Cutrona 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.

  PMID: 22618980 BACKGROUND

• van 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.

  PMID: 25062071 BACKGROUND

• Wroe AL. Intentional and unintentional nonadherence: a study of decision making. J Behav Med. 2002 Aug;25(4):355-72. doi: 10.1023/a:1015866415552.

  PMID: 12136497 BACKGROUND

• Clifford 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.

  PMID: 18157998 BACKGROUND

• Alfian 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.

  PMID: 31911526 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sofa D Alfian

  University of Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered pharmacist

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 17, 2019
• Study Start: August 16, 2019
• Primary Completion: December 30, 2019
• Study Completion: January 30, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)