Clinical trial NCT05106231: Effectiveness of PICC Improving HBA1C and Knowledge in Diabetes Mellitus Education
Official title: Effectiveness of Pharmacy Integrated Community Care (PICC) Improving Hemoglobin A1c (HBA1C) and Knowledge in Diabetes Mellitus (DM) Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Type2 Diabetes
Keywords: diabetes mellitus
Type2 diabetes
group based intervention
patient integrated community care (PICC)
Lead sponsor: Clinical Research Centre, Malaysia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
First posted: 2021-11-03
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: laboratory-analysed HbA1C improvement (HbA1c level below 42mmol/mol or 6.5%)
timeFrame: 4 months
Secondary outcomes:
measure: Diabetes knowledge improvement (scores in percentage)
timeFrame: 4 months
Other outcomes:
Locations:
city: Daro
country: Malaysia
facility: Klinik Kesihatan Daro
state: Sarawak
city: Kapit
country: Malaysia
facility: Klinik Kesihatan Kapit
state: Sarawak
city: Kuching
country: Malaysia
facility: Klinik Kesihatan Jalan Masjid Kuching
state: Sarawak
city: Miri
country: Malaysia
facility: Klinik Kesihatan Bandar Miri
state: Sarawak
city: Pusa
country: Malaysia
facility: Klinik Kesihatan Pusa
state: Sarawak
city: Sarikei
country: Malaysia
facility: Klinik Kesihatan Sarikei
state: Sarawak
city: Serian
country: Malaysia
facility: Klinik Kesihatan Siburan
state: Sarawak
city: Sibu
country: Malaysia
facility: Klinik Kesihatan Jalan Oya
state: Sarawak
city: Simanggang
country: Malaysia
facility: Klinik Kesihatan Sri Aman
state: Sarawak
Study officials:
affiliation: Jabatan Farmasi, Hospital Miri
name: Kamarudin Ahmad, B.Pharm
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.