Effectiveness of PICC Improving HBA1C and Knowledge in Diabetes Mellitus Education

NCT ID: NCT05106231

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-12-31

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.

Conditions

Diabetes Mellitus; Type2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

PICC arm

Participants assigned to the intervention group will attend the PICC program, which will take four-month and each session 2.5 hours.

Group Type: EXPERIMENTAL

PICC Program

Intervention Type: 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.

Control arm

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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Pharmacy Integrated Community Care; DMTAC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role: collaborator

Clinical Research Centre, Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Kamarudin Bin Ahmad

Chief Pharmacist, Miri Hospital Sarawak

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamarudin Ahmad, B.Pharm

Role: PRINCIPAL_INVESTIGATOR

Jabatan Farmasi, Hospital Miri

Locations

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, Malaysia

Countries

Malaysia

References

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.

Reference Type: BACKGROUND

PMID: 31077233 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21772732 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15707260 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38435429 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: study protocol Version 7.0 dated February 14, 2024_archive

View Document

Related Links

https://www.spirit-statement.org/

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

Other Identifiers

NMRR-21-767-59240

Identifier Type: -

Identifier Source: org_study_id