Diabetes Mellitus, Type2 Diabetes
Conditions
Keywords
diabetes mellitus, Type2 diabetes, group based intervention, patient integrated community care (PICC)
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.
Interventions
BEHAVIORALPICC 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.
BEHAVIORALControl
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.
Sponsors
Ministry of Health, Malaysia
Clinical Research Centre, Malaysia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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).
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| laboratory-analysed HbA1C improvement (HbA1c level below 42mmol/mol or 6.5%) | 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes knowledge improvement (scores in percentage) | 4 months | PICC improved diabetic knowledge scores (score above or equal to 80% up to 100% showing good knowledge) |
Countries
Malaysia
Outcome results
None listed