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| Name | Class |
|---|---|
| Ministry of Health, Malaysia | OTHER_GOV |
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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 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:
Specific Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICC arm | Experimental | Participants assigned to the intervention group will attend the PICC program, which will take four-month and each session 2.5 hours. |
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| Control arm | Active Comparator | Participants assigned to the DMTAC group will receive a standard intervention of pharmacist-led education. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICC Program | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamarudin Ahmad, B.Pharm | Jabatan Farmasi, Hospital Miri | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Kesihatan Daro | Daro | Sarawak | 96200 | Malaysia | ||
| Klinik Kesihatan Kapit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31077233 | Background | 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. | |
| 21772732 |
| Label | URL |
|---|---|
| The protocol is written following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. | View source |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: study protocol Version 7.0 dated February 14, 2024_archive | Feb 14, 2024 | Feb 14, 2024 | Prot_SAP_ICF_003.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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The study's design 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 four-session structured group-based intervention (SGBI) of a two to three-hour pharmacist-led program with follow up evaluations. The control arm will have the same syllabus without SGBI.
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For the blinding of researchers, they remain blinded towards the stage of publication. During the post-intervention follow up, the researchers still are blinded by the participants' allocation, as the Sarawak Pharmacy Service Division keeps the participant list with group allocation. None of the instruments distributed to the participants will disclose their name and group assignment to assure the blinding among researchers who do the data analyses. Only after this study's results are published, the blinding or the codes will be broken through the return of the participants' list to the principal investigator. The Sarawak Pharmacy Service Division will maintain the randomisation codes throughout the study without disclosing them to the researchers or the participants. No breaking code procedure is necessary for this study as the intervention of this study is educational and does not involve the investigation of medicinal products (IMP).
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| Control | Behavioral | 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. |
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| Kapit |
| Sarawak |
| 96800 |
| Malaysia |
| Klinik Kesihatan Jalan Masjid Kuching | Kuching | Sarawak | 93050 | Malaysia |
| Klinik Kesihatan Bandar Miri | Miri | Sarawak | 98000 | Malaysia |
| Klinik Kesihatan Pusa | Pusa | Sarawak | 94950 | Malaysia |
| Klinik Kesihatan Sarikei | Sarikei | Sarawak | 96100 | Malaysia |
| Klinik Kesihatan Siburan | Serian | Sarawak | 94200 | Malaysia |
| Klinik Kesihatan Jalan Oya | Sibu | Sarawak | 96000 | Malaysia |
| Klinik Kesihatan Sri Aman | Simanggang | Sarawak | 95000 | Malaysia |
| Background |
| 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. |
| 15707260 | Background | 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. |
| 38435429 | Derived | Ahmad K, Anchah L, Ting CY, Lim SE. Effectiveness of a pharmacist-led, community group-based education programme in enhancing diabetes management: A multicentre randomised control trial. Contemp Clin Trials Commun. 2024 Feb 24;38:101280. doi: 10.1016/j.conctc.2024.101280. eCollection 2024 Apr. |