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Trial registered on ANZCTR

Registration number

ACTRN12618000839202

Ethics application status

Approved

Date submitted

14/05/2018

Date registered

18/05/2018

Date last updated

17/05/2019

Date data sharing statement initially provided

17/05/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Economic evaluation and clinical impact of home medication review (HMR) by community pharmacists among patients with type 2 diabetes mellitus (T2DM)

Scientific title

Economic evaluation and clinical impact of home medication review (HMR) by community pharmacists among patients with type 2 diabetes mellitus (T2DM)

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1208-0306

Trial acronym

HMR-CPT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

TYPE 2 DIABETES MELLITUS

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study will adopt a randomized clinical trial (RCT) design. Subjects in the control group will have routine follow up at health clinics without receiving home medication review from the community pharmacists. While in the intervention group, the subjects will received additional process of treatment. They will have home medication review by community pharmacists at 0-month, 3-month and 6-month. The established protocol of HMR by Pharmaceutical Service Division, MOH, Malaysia will be referred in developing the program. During the HMR session, there will be discussion about medication and information about disease between patients and community pharmacists, reviewing how patients used and storage of medication, doing intervention for any pharmaceutical care issues and lifestyle modification to have better disease management. All community pharmacists who participate in this program have a valid license A to practice as community pharmacists. They will provide the intervention with face-to-face mode in the patients' house.The duration of intervention is approximately 30 minutes .

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Comparator / control treatment

active control. The control group will received a standard treatment procedure by Bandar Pasir Mas Health Clinic. The subjects will have normal routine check-up by medical officer on-duty and taking a medicine supplied by Bandar Pasir Mas Health Clinic.

Control group

Active

Outcomes

Primary outcome [1]

A sample of blood is taken from patients to measure HbA1c (glycated haemoglobin, haemoglobin A1c) value using chromatography based HPLC assay.

Timepoint [1]

0-month, 3-month, and 6-month post-enrolement

Primary outcome [2]

Cost-effectiveness of the home medication review program. The cost will be calculated based on the provider (Ministry of Health, Malaysia) perspective.Activity based costing (ABC) will be used in analyzing the true cost for this program. The cost-effectiveness will be assessed by actual cost involve for this program and HbA1c reduction.

Timepoint [2]

0-month, 3-month, 6-month post-enrolment

Secondary outcome [1]

number of drug related problem (DRP). Pharmaceutical care Network Europe (PCNE) classification for drug related problem will be used to measure DRP.

Timepoint [1]

0-month, 3-month, 6-month post-enrolment

Secondary outcome [2]

medication adherence. Pill count chart will be used as a method for measurement medication adherence.

Timepoint [2]

0-month, 3-month, 6-month post-enrolement

Secondary outcome [3]

patients' quality of life. Euro Quality of Lfe (EQ5D-5L) used to measure patients' quality of life.

Timepoint [3]

0-month, 3-month, 6-month post-enrolment

Secondary outcome [4]

patients' knowledge about the disease. 14-item Michigan Diabetes Knowledge Test (MDKT) used to measure patients' knowledge about the disease.

Timepoint [4]

0-month, 3-month, 6-month post-enrolment

Secondary outcome [5]

Wastage of medicine supplied by MOH, Malaysia will be calculated based on excessive medicine hold by patients

Timepoint [5]

0-month, 3-month, 6-month post-enrolment

Secondary outcome [6]

stake holders' perception about HMR-CP. The focus group discussion will be done between between medical officer, family medicine specialist, and pharmacist who involve in this project and one-to-one interview will be organized for patients.

Timepoint [6]

7-month post enrolment

Eligibility

Key inclusion criteria

1. Adult patients (more than 18 years old) diagnosed with Type 2 Diabetes Mellitus.
2. Patients with current HbA1C more than 6.5%
3. Patients taking five (5) or more medications for long term therapy or taking more than twelve (12) doses of medications daily.
4. Patients stayed in 25 km radius from Bandar Pasir Mas Health Clinic

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Enduring mental health problems or dependant with caretaker
2. Insufficient understanding of English/ Bahasa Malaysia.
3. Patients who are homeless or do not have a proper place to stay.
4. Foreign workers or non-permanents residents.
5. Patients with blood disorders (i.e. haemolytic anemia, haemoglobinopathy22, chronic lymphocytic leukemia).
6. Patients diagnosed with chronic kidney disease.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomization using a randomization table created by Microsoft Excel 2016.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Based on an expected average value of HbA1c at 9.23% for the control group, an expected average reduction of 1.04% HbA1c in intervention group, with standard deviation of 2.16%, a power of 80% and a two-tailed alpha of 0.05, the required sample size is 69 intervention subjects and 69 control subjects. Allowing for a dropout/loss to follow-up rate of 20%, at least 166 participants will be recruited, 83 experimental subjects and 83 control subjects. This was calculated using PS Power and Sample Size Calculations (Version 3.0, Dupont & Plummer, 2009).

All collected data will be analysed using statistical software IBM SPSS version 22. Categorical variables will be presented using descriptive statistics (frequency, percentage, median) whereas continuous data will be presented as mean ± standard deviation. For continuous data, independent t-test (Mann-Whitney test if non-parametric) and two-way repeated measures ANOVA (Friedman test if non-parametric) will be used accordingly to compare the differences between different time-points. On the other hand, chi-square test will be used for comparisons of categorical data. A significance level for this study is set at 0.05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

28/01/2018

Date of last participant enrolment

Anticipated

Actual

14/05/2018

Date of last data collection

Anticipated

31/03/2019

Actual

31/03/2019

Sample size

Target

166

Accrual to date

Final

166

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

17000

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Klinik Kesihatan Bandar Pasir Mas

Address [1]

Jalan Hospital, Pekan Pasir Mas, 17000 Pasir Mas, Kelantan

Country [1]

Malaysia

Primary sponsor type

University

Name

Faculty of Pharmacy, UiTM

Address

Faculty of Pharmacy Level 11, FF1 Building, UiTM Puncak Alam Campus, 42300 Bandar Puncak Alam, Selangor

Country

Malaysia

Secondary sponsor category [1]

Government body

Name [1]

Ministry of Health, Malaysia

Address [1]

Kompleks E, Pusat Pentadbiran Kerajaan Persekutuan,
62590, Putajaya,

Country [1]

Malaysia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Medical Research & Ethic Committee, Ministry of Health, Malaysia

Ethics committee address [1]

Institut Pengurusan Kesihatan, Jalan Rumah Sakit, Bangsar, 59000, Kuala Lumpur

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

19/09/2017

Approval date [1]

09/01/2018

Ethics approval number [1]

NMRR-17-2348-37624 (IIR)

Summary

Brief summary

Home Medication Review (HMR), also known as ‘pharmacist-led medication review’ is defined as ‘systematic assessment of consumer’s medication and management of those medications with the aim of optimising consumer health outcome and identifying potential medication-related issues within framework of the quality use of medicine’. Numerous overseas studies have demonstrated that HMR could benefit patients with multiple chronic conditions, age or social circumstance, complexity of their drug regimen, and lack of knowledge or skill on using medication or medication device. The new extension in the role of community pharmacists in pharmaceutical care is anticipated given the increasing number of community pharmacists recently. HMR conducted by community pharmacists (HMR-CP), a comprehensive clinical review of a patient's medicines at his/her home by an accredited community pharmacists upon referral from the patient's Family Medicine Specialist (FMS) or general practitioner (GP), could have benefit T2DM patients who live independently in the community and this warrants for further investigations. The general objective of the study is to develop and evaluate home medication review by community pharmacists (HMR-CP) programme in optimising diabetes care in Malaysia. While the specific objectives are to determine the clinical impact of HMR-CP among patients with T2DM, to determine the humanistic outcomes of HMR-CP among T2DM patients, to determine the cost-effectiveness of implementing HMR-CP in Malaysia and to explore stake holders’ perception on implementation of HMR-CP. The study is mainly divided into 5 stages: pre-intervention phase, training the community pharmacists, pilot study and intervention phase, economic evaluation, and qualitative review from healthcare professionals and patients. A patients with Type 2 Diabetes Mellitus patients from Bandar Pasir Mas Health Clinic who fulfill the inclusion and exclusion criteria will be randomly assigned into two groups: intervention group who will received HMR-CP and controlled group. The primary outcome of this study is the reduction of HbA1c percentage. Four secondary outcomes will be measured: Clinical parameters (i.e. fasting blood glucose, blood pressure and body mass index), medication / medical related issues, medication adherence and wastage of medication will be measure. Besides that, the cost effectiveness of this HMR-CP programme will be evaluated. After the HMR-CP programme, the researcher will conduct a focus group discussion between the healthcare professional (i.e. FMS and community pharmacists) and one-to-one interview with patients to explore the view of the stakeholders on HMR-CP.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Mohd Rozaini b Rosli

Address

Faculty of Pharmacy Level 11, FF1 Building, UiTM Puncak Alam Campus, 42300 Bandar Puncak Alam, Selangor

Country

Malaysia

Phone

+6012-2729345

Fax

+603 - 32584602

[email protected]

Contact person for public queries

Name

Mohd Rozaini b Rosli

Address

Faculty of Pharmacy Level 11, FF1 Building, UiTM Puncak Alam Campus, 42300 Bandar Puncak Alam, Selangor

Country

Malaysia

Phone

+6012-2729345

Fax

+603 - 32584602

[email protected]

Contact person for scientific queries

Name

Neoh Chin Fen

Address

Faculty of Pharmacy Level 11, FF1 Building, UiTM Puncak Alam Campus, 42300 Bandar Puncak Alam, Selangor

Country

Malaysia

Phone

+6017-5839340

Fax

+603 - 32584602

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

The data is consider confidential to the site study.

What supporting documents are/will be available?

Doc. No.	Type	Other Details	Attachment
1934	Study protocol	study protocol	374326-(Uploaded-24-04-2019-13-32-33)-Study-related document.pdf
1935	Informed consent form	consent form	374326-(Uploaded-24-04-2019-13-33-30)-Study-related document.pdf
1936	Ethical approval	ethical approval from NMRR	374326-(Uploaded-24-04-2019-13-34-07)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Economic evaluation of home medication review by community pharmacists (HMR-CP) for patients with type 2 diabetes mellitus (T2DM).	2021	https://dx.doi.org/10.1080/13696998.2021.1889573
Embase	Evaluation of home medication review for patients with type 2 diabetes mellitus by community pharmacists: A randomised controlled trial.	2021	https://dx.doi.org/10.18549/PHARMPRACT.2021.3.2397

N.B. These documents automatically identified may not have been verified by the study sponsor.

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