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Effect of pharmacist involvement in Diabetes Medication Therapy Adherence Program (DMTAC) on the clinical outcomes of diabetes in two different hospitals of Kedah state Malaysia

Effect of pharmacist involvement in Diabetes Medication Therapy Adherence Program (DMTAC) on the clinical outcomes in type 2 diabetes mellitus - a multicentre randomised control trial

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001128886
Enrollment
299
Registered
2021-08-23
Start date
2018-09-03
Completion date
2018-12-06
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The general objective of the present study is to evaluate the impact of pharmacist intervention in DMTAC services of the public hospital in Kedah state of Malaysia on clinical outcomes (in the form of HbA1c) of diabetes mellitus, Null Hypothesis: H0: DMTAC services in public hospitals of Malaysia do not have any significant effect on the clinical outcomes on diabetic patients. Alternative Hypothesis: H1: DMTAC services in public hospitals of Malaysia have a significant effect on the clinical outcomes on diabetic patients.

Interventions

The Ministry of Health Malaysia has provided the protocol far diabetic medication therapy adherence clinic as a informational material for pharmacist intervention. The length of each visit is 30 to 40 minutes. Whereas the time between visits is two to three months depending on the patient condition. All study visits will be conducted over a 10- 12 month period. The brief description off provided material was as follows: First Module of Patient Education (for visit 1 and 2) The first educationa

The Ministry of Health Malaysia has provided the protocol far diabetic medication therapy adherence clinic as a informational material for pharmacist intervention. The length of each visit is 30 to 40 minutes. Whereas the time between visits is two to three months depending on the patient condition. All study visits will be conducted over a 10- 12 month period. The brief description off provided material was as follows: First Module of Patient Education (for visit 1 and 2) The first educational module covers the following education for the patients A basic outline of diabetes (signs and symptoms, complications, etc.). Therapeutic goals, especially blood glucose (FBG and HbA1c, etc.). A detailed discussion with the diabetic patient on use/adverse effects of medicines (insulin and hypoglycaemic agents). Self-monitoring of blood glucose levels by patients - how, when, why etc. (if applicable). Signs and symptoms of hypoglycaemia and hyperglycaemia, how to manage at home, sick day management and sequence of actions to be taken. Storage of anti-diabetic medications at home. Explanation to the patient concerns Second module of patient education (for visit 3 and 4) The second module covers the following education for the patients Cardiovascular education of the patients (Lipid profile, blood pressure, peripheral vascular disease, and goals). Benefits for achieving target blood glucose levels and risks for not control or poor control of blood glucose levels. Explanation on medication use and adverse effects of medicines to the patients (anti-hypertensives, anti-platelets, and anti-cholesterol). Explanation to the patient concerns. Third module of patient education (for visit 5 and 6) The third educational module covers the following education for the patients Benefits of exercise. Reminder about the hypoglycaemic reactions. Basic important nutritions. Introduction to the benefits of quit smoking. Introduction and explanation about the health benefits of quit smoking. Explanation to the patient concerns Fourth module of patient education (for visit 7 and 8) The fourth educational module covers following education for the patients Detailed discussion on diabetes complications (macrovascular and microvascular complications). Prevention, recognition, and treatment of diabetic complications. Explanation about foot care. Explanation to the patient concerns. Benefits of exercise Well trained clinical pharmacist appointed by Ministry of Health Malaysia will deliver the intervention. The mode of delivery is face to face and it will be provided individually to the patients. The approximate length for each visit was one to two months depending on the patient condition And One module of the protocol was covered in two visits. The location of the intervention occurs in the diabetes medication therapy adherence clinics under the clinical services in hospitals- In Malaysia in all the tertiary hospitals diabetes medication therapy adherence clinics are running by the help of well-trained clinical pharmacist besides the endocrinology clinics. Diabetes medication adherence clinics in Malaysia have their own adherence scale to measure the adherence of the patients.

Sponsors

Muhammad Zahid Iqbl
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
30 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients who are having Diabetes mellitus since a minimum of 5 years and HbA1c more than 8.0% and receiving medicine from any selected hospital. Total 200 patients required in each selected hospital and from those 200 patients 100 will be taken from Diabetic clinics and 100 will be taken from DMTAC clinics

Exclusion criteria

Pregnant diabetic patients, HIV / cancer patients, Incomplete Patient Record,Children with CKD, Newly diagnosed patients

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026