Effectiveness of PICC Improving HBA1C and Knowledge in Diabetes Mellitus Education

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Type2 Diabetes
• Interventions: Behavioral: PICC Program; Behavioral: Control

• Registration Number: NCT05106231
• Lead Sponsor: Clinical Research Centre, Malaysia

Brief Summary

The Ministry of Health Malaysia designs an education program for diabetes mellitus under the "Know Your Medicine" campaign. The Pharmacy Integrated Community Care (PICC) program hopes to improve knowledge and self-care for diabetes mellitus patients. PICC contains four modules that will provide knowledge on diabetes mellitus in an interactive, easily understandable and fun program. The investigators want to evaluate the program's effectiveness to see its relevance to Malaysian.

PICC is an education program to give knowledge on diabetes mellitus to patients. It intended to improve self-care knowledge for patients with underlying Type 2 Diabetes Mellitus conducted the whole of Malaysia. However, in Sarawak, the investigators interested in conducting it together with this is an experimental study aiming to examine PICC's effectiveness. The study is being conducted in the nine Sarawak divisions. A minimum of 94 respondents will be participating in this study. Patient profile details will be taken with strict confidentiality.

Detailed Description

Study title: Effectiveness of Pharmacy Integrated Community Care (PICC) Improving Hemoglobin A1c (HBA1C) and Knowledge in diabetes mellitus (DM) education program

Study Population: The population will be local people living in Sarawak from multiple racial backgrounds with underlying type 2 diabetes mellitus (T2DM). The investigators recruit patients with underlying T2DM mellitus who obtain medication at each district's primary Government Health Clinic.

Study Design: The study will be a prospective, multicenter and parallel-design single-blind randomised controlled with two treatment groups. The trial evaluates a PICC's effectiveness in improving HBA1C involving a four-session structured group-based intervention (SGBI) of a two to three-hour pharmacist-led program with follow-up evaluations. The control arm will be the Diabetes Mellitus Therapy Adherence Clinic (DMTAC). DMTAC is a gold standard for pharmacy-led DM education in Malaysia and an individualised-based program.

General Objective:

1. To describe and critically appraise DM education studies in Malaysia.

2. To examine the program's effectiveness versus control in improving medication adherence with underlying T2DM in the Sarawak State of Malaysia.

Specific Objectives:

1. To measure the effectiveness of PICC in improving HbA1C, fasting blood glucose and understanding

2. To investigate the sustainability of the program.

Study endpoints/outcomes:

Primary outcome: laboratory-analysed HbA1C will be the primary outcome. Secondary outcome: Investigating knowledge and understanding of DM medication management will be evaluated using the quizzes in the PICC program.

Sample Size: A previous study has shown a standard deviation of 1.5. Suppose the actual difference between the experimental and control means is 1, 36 experimental and 36 control subjects with a probability (power) of 0.8. By estimating 30% dropout or incomplete data, a minimum sample size of 94 (47 for each group).

Study Duration: 1 October to 31 January 2022.

Study Timeline

• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-11-03
• Study Start: 2023-05-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

1. were non-pregnant adults >18 years of age regardless of gender or ethnicity;
2. spoke and understood Bahasa Malaysia
3. had a medical record showing haemoglobin A1c test (HbA1c) level of ≥6.3% (45 mmol/mol) and fasting plasma glucose test (FPG) ≥7.0 mmol/L
4. Patients also need to be able to provide informed consent to participate in the study

Exclusion Criteria

1. Participants were excluded if they could not answer the quizzes independently or had a hearing or vision impairment.
2. Patients unable to read, write and speak Malay, medically unstable or unable to provide informed consent will be excluded.
3. Patients who are currently attending intensive psychological treatment, hospitalised and participating in other studies will also be excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PICC arm	PICC Program	Participants assigned to the intervention group will attend the PICC program, which will take four-month and each session 2.5 hours.
Control arm	Control	Participants assigned to the DMTAC group will receive a standard intervention of pharmacist-led education.

Primary Outcome Measures

Name	Time	Method
laboratory-analysed HbA1C improvement (HbA1c level below 42mmol/mol or 6.5%)	4 months	PICC education influencing change in HBA1C (HbA1c level below 42mmol/mol or 6.5% -CDC guideline on diabetes) using finger prick test within 4 month.

Secondary Outcome Measures

Name	Time	Method
Diabetes knowledge improvement (scores in percentage)	4 months	PICC improved diabetic knowledge scores (score above or equal to 80% up to 100% showing good knowledge)

Trial Locations

Locations (9)

Klinik Kesihatan Daro; 🇲🇾 Daro, Sarawak, Malaysia

Klinik Kesihatan Jalan Masjid Kuching; 🇲🇾 Kuching, Sarawak, Malaysia

Klinik Kesihatan Bandar Miri; 🇲🇾 Miri, Sarawak, Malaysia

Klinik Kesihatan Pusa; 🇲🇾 Pusa, Sarawak, Malaysia

Klinik Kesihatan Sarikei; 🇲🇾 Sarikei, Sarawak, Malaysia

Klinik Kesihatan Siburan; 🇲🇾 Serian, Sarawak, Malaysia

Klinik Kesihatan Jalan Oya; 🇲🇾 Sibu, Sarawak, Malaysia

Klinik Kesihatan Sri Aman; 🇲🇾 Simanggang, Sarawak, Malaysia

Klinik Kesihatan Kapit; 🇲🇾 Kapit, Sarawak, Malaysia