Trial Review

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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] 293816 0
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 306230 0
Condition category
Condition code
Metabolic and Endocrine 305332 305332 0 0
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] 300068 0
Treatment: Other
Intervention code [2] 300070 0
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] 304503 0
A sample of blood is taken from patients to measure HbA1c (glycated haemoglobin, haemoglobin A1c) value using chromatography based HPLC assay.
Timepoint [1] 304503 0
0-month, 3-month, and 6-month post-enrolement
Primary outcome [2] 304504 0
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] 304504 0
0-month, 3-month, 6-month post-enrolment
Secondary outcome [1] 342171 0
number of drug related problem (DRP). Pharmaceutical care Network Europe (PCNE) classification for drug related problem will be used to measure DRP.
Timepoint [1] 342171 0
0-month, 3-month, 6-month post-enrolment
Secondary outcome [2] 342172 0
medication adherence. Pill count chart will be used as a method for measurement medication adherence.
Timepoint [2] 342172 0
0-month, 3-month, 6-month post-enrolement
Secondary outcome [3] 342173 0
patients' quality of life. Euro Quality of Lfe (EQ5D-5L) used to measure patients' quality of life.
Timepoint [3] 342173 0
0-month, 3-month, 6-month post-enrolment
Secondary outcome [4] 342174 0
patients' knowledge about the disease. 14-item Michigan Diabetes Knowledge Test (MDKT) used to measure patients' knowledge about the disease.
Timepoint [4] 342174 0
0-month, 3-month, 6-month post-enrolment
Secondary outcome [5] 342175 0
Wastage of medicine supplied by MOH, Malaysia will be calculated based on excessive medicine hold by patients
Timepoint [5] 342175 0
0-month, 3-month, 6-month post-enrolment
Secondary outcome [6] 342176 0
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] 342176 0
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?
No
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] 9506 0
Malaysia
State/province [1] 9506 0
17000

Funding & Sponsors
Funding source category [1] 298429 0
Government body
Name [1] 298429 0
Klinik Kesihatan Bandar Pasir Mas
Country [1] 298429 0
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] 298784 0
Government body
Name [1] 298784 0
Ministry of Health, Malaysia
Address [1] 298784 0
Kompleks E, Pusat Pentadbiran Kerajaan Persekutuan,
62590, Putajaya,
Country [1] 298784 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299426 0
Medical Research & Ethic Committee, Ministry of Health, Malaysia
Ethics committee address [1] 299426 0
Ethics committee country [1] 299426 0
Malaysia
Date submitted for ethics approval [1] 299426 0
19/09/2017
Approval date [1] 299426 0
09/01/2018
Ethics approval number [1] 299426 0
NMRR-17-2348-37624 (IIR)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80362 0
Mr Mohd Rozaini b Rosli
Address 80362 0
Faculty of Pharmacy Level 11, FF1 Building, UiTM Puncak Alam Campus, 42300 Bandar Puncak Alam, Selangor
Country 80362 0
Malaysia
Phone 80362 0
+6012-2729345
Fax 80362 0
+603 - 32584602
Email 80362 0
[email protected]
Contact person for public queries
Name 80363 0
Mohd Rozaini b Rosli
Address 80363 0
Faculty of Pharmacy Level 11, FF1 Building, UiTM Puncak Alam Campus, 42300 Bandar Puncak Alam, Selangor
Country 80363 0
Malaysia
Phone 80363 0
+6012-2729345
Fax 80363 0
+603 - 32584602
Email 80363 0
[email protected]
Contact person for scientific queries
Name 80364 0
Neoh Chin Fen
Address 80364 0
Faculty of Pharmacy Level 11, FF1 Building, UiTM Puncak Alam Campus, 42300 Bandar Puncak Alam, Selangor
Country 80364 0
Malaysia
Phone 80364 0
+6017-5839340
Fax 80364 0
+603 - 32584602
Email 80364 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data is consider confidential to the site study.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEconomic evaluation of home medication review by community pharmacists (HMR-CP) for patients with type 2 diabetes mellitus (T2DM).2021https://dx.doi.org/10.1080/13696998.2021.1889573
EmbaseEvaluation of home medication review for patients with type 2 diabetes mellitus by community pharmacists: A randomised controlled trial.2021https://dx.doi.org/10.18549/PHARMPRACT.2021.3.2397
N.B. These documents automatically identified may not have been verified by the study sponsor.