Effectiveness of PICC Improving HBA1C and Knowledge in Diabetes Mellitus Education

NCT05106231 | Completed

• 1 other identifier: NMRR-21-767-59240
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 9

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.

Conditions

Diabetes Mellitus; Type2 Diabetes

Keywords

diabetes mellitus; Type2 diabetes; group based intervention; patient integrated community care (PICC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diabetes knowledge improvement (scores in percentage)

  4 months

Study Arms (2)

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.

Behavioral: PICC Program

Control arm

ACTIVE COMPARATOR

Participants assigned to the DMTAC group will receive a standard intervention of pharmacist-led education.

Behavioral: Control

Interventions

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.

Also known as: Pharmacy Integrated Community Care

PICC arm

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.

Also known as: DMTAC

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• were non-pregnant adults \>18 years of age regardless of gender or ethnicity;
• spoke and understood Bahasa Malaysia
• 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
• Patients also need to be able to provide informed consent to participate in the study

You may not qualify if:

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

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead
• Ministry of Health, Malaysia: collaborator

Study Sites (9)

Klinik Kesihatan Daro

Daro, Sarawak, 96200, Malaysia

Location

Klinik Kesihatan Kapit

Kapit, Sarawak, 96800, Malaysia

Location

Klinik Kesihatan Jalan Masjid Kuching

Kuching, Sarawak, 93050, Malaysia

Location

Klinik Kesihatan Bandar Miri

Miri, Sarawak, 98000, Malaysia

Location

Klinik Kesihatan Pusa

Pusa, Sarawak, 94950, Malaysia

Location

Klinik Kesihatan Sarikei

Sarikei, Sarawak, 96100, Malaysia

Location

Klinik Kesihatan Siburan

Serian, Sarawak, 94200, Malaysia

Location

Klinik Kesihatan Jalan Oya

Sibu, Sarawak, 96000, Malaysia

Location

Klinik Kesihatan Sri Aman

Simanggang, Sarawak, 95000, Malaysia

Location

Related Publications (4)

• 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.

  PMID: 31077233 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.

  PMID: 21772732 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.

  PMID: 15707260 BACKGROUND

• 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.

  PMID: 38435429 DERIVED

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kamarudin Ahmad, B.Pharm

  Jabatan Farmasi, Hospital Miri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Pharmacist, Miri Hospital Sarawak

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: November 3, 2021
• Study Start: May 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (9)