Effectiveness of PICC Improving HBA1C and Knowledge in Diabetes Mellitus Education

Diabetes Mellitus Clinical Trial

— EPICCIHKDMEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05106231
• Other study ID #: NMRR-21-767-59240
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Clinical Research Centre, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Malaysia	Klinik Kesihatan Daro	Daro	Sarawak
Malaysia	Klinik Kesihatan Kapit	Kapit	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

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Research Centre, Malaysia	Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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