Effectiveness of PICC Improving HBA1C and Knowledge in Diabetes Mellitus Education (EPICCIHKDMEP)

Effectiveness of Pharmacy Integrated Community Care (PICC) Improving Hemoglobin A1c (HBA1C) and Knowledge in Diabetes Mellitus (DM) Education Program

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Type2 Diabetes
• Intervention / Treatment: Behavioral: PICC Program; Behavioral: Control

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Sarawak
    • Daro, Sarawak, Malaysia, 96200
      • Klinik Kesihatan Daro
    • Kapit, Sarawak, Malaysia, 96800
      • Klinik Kesihatan Kapit
    • Kuching, Sarawak, Malaysia, 93050
      • Klinik Kesihatan Jalan Masjid Kuching
    • Miri, Sarawak, Malaysia, 98000
      • Klinik Kesihatan Bandar Miri
    • Pusa, Sarawak, Malaysia, 94950
      • Klinik Kesihatan Pusa
    • Sarikei, Sarawak, Malaysia, 96100
      • Klinik Kesihatan Sarikei
    • Serian, Sarawak, Malaysia, 94200
      • Klinik Kesihatan Siburan
    • Sibu, Sarawak, Malaysia, 96000
      • Klinik Kesihatan Jalan Oya
    • Simanggang, Sarawak, Malaysia, 95000
      • Klinik Kesihatan Sri Aman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PICC arm; Participants assigned to the intervention group will attend the PICC program, which will take four-month and each session 2.5 hours.	Behavioral: PICC Program; Participants will attend the PICC program which consists of 4 sessions that involve Visualization in Participatory Programmes (VIPP) and quizzes to evaluate retention in diabetes knowledge.; Other Names: Pharmacy Integrated Community Care
Active Comparator: Control arm; Participants assigned to the DMTAC group will receive a standard intervention of pharmacist-led education.	Behavioral: Control; The control arm received four sessions one-on-one education program by a pharmacist. It is a Malaysian national education pharmacy-led program to instil knowledge and inculcate medication adherence.; Other Names: DMTAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
laboratory-analysed HbA1C improvement (HbA1c level below 42mmol/mol or 6.5%)	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.	4 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clinical Research Centre, Malaysia
• Collaborators: Ministry of Health, Malaysia
• Investigators: Principal Investigator: Kamarudin Ahmad, B.Pharm, Jabatan Farmasi, Hospital Miri

Publications and helpful links

General Publications

• Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.
• Ting CY, Adruce SAZ, Hassali MA, Ting H, Lim CJ, Ting RS, Jabar AHAA, Osman NA, Shuib IS, Loo SC, Sim ST, Lim SE. Correction to: Effectiveness and sustainability of a structured group-based educational program (MEDIHEALTH) in improving medication adherence among Malay patients with underlying type 2 diabetes mellitus in Sarawak State of Malaysia: study protocol of a randomized controlled trial. Trials. 2019 May 10;20(1):267. doi: 10.1186/s13063-019-3348-x.
• Soto-Greene ML, Salas-Lopez D, Sanchez J, Like RC. Antecedents to effective treatment of hypertension in Hispanic populations. Clin Cornerstone. 2004;6(3):30-6; discussion 37-8. doi: 10.1016/s1098-3597(04)80062-0.

Helpful Links

• The protocol is written following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: diabetes mellitus; Type2 diabetes; group based intervention; patient integrated community care (PICC)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NMRR-21-767-59240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data collection forms are not in codes. Site investigators and participants have access to individual case report forms because the information is transparent to those involved.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No