Effectiveness of PICC Improving HBA1C and Knowledge in Diabetes Mellitus Education

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:

• To describe and critically appraise DM education studies in Malaysia.
• To examine the program's effectiveness versus control in improving medication adherence with underlying T2DM in the Sarawak State of Malaysia.

Specific Objectives:

• To measure the effectiveness of PICC in improving HbA1C, fasting blood glucose and understanding
• 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.

Inclusion criteria

• 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

Exclusion criteria

• 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.