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Diabetes MellitusEPICCIHKDMEPNCT05106231

Effectiveness of PICC Improving HBA1C and Knowledge in Diabetes Mellitus Education

A study testing PICC Program in people with Diabetes Mellitus and Type2 Diabetes, run by Clinical Research Centre, Malaysia at 9 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type2 Diabetes
What is being tested?
PICC Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
9 sitesMalaysia
Study dates
1 May 2023to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Malaysia9 sites

  • Klinik Kesihatan Daro

    Daro, Sarawak, 96200

  • Klinik Kesihatan Kapit

    Kapit, Sarawak, 96800

  • Klinik Kesihatan Jalan Masjid Kuching

    Kuching, Sarawak, 93050

  • Klinik Kesihatan Bandar Miri

    Miri, Sarawak, 98000

  • Klinik Kesihatan Pusa

    Pusa, Sarawak, 94950

  • Klinik Kesihatan Sarikei

    Sarikei, Sarawak, 96100

  • Klinik Kesihatan Siburan

    Serian, Sarawak, 94200

  • Klinik Kesihatan Jalan Oya

    Sibu, Sarawak, 96000

  • Klinik Kesihatan Sri Aman

    Simanggang, Sarawak, 95000

Other trials in Malaysia

About this study

Official title: Effectiveness of Pharmacy Integrated Community Care (PICC) Improving Hemoglobin A1c (HBA1C) and Knowledge in Diabetes Mellitus (DM) Education Program

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.

Read the 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.

Being tested
PICC Program, Control
Keywords
diabetes mellitus, Type2 diabetes, group based intervention, patient integrated community care (PICC)
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PICC ProgramBehavioural

    Also called Pharmacy Integrated Community Care

    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.

  • ControlBehavioural

    Also called DMTAC

    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.

Study groups in NCT05106231
Study groupRoleWhat they receive
PICC armExperimentalParticipants assigned to the intervention group will attend the PICC program, which will take four-month and each session 2.5 hours.
Receives: Behavioral: PICC Program
Control armActive comparatorParticipants assigned to the DMTAC group will receive a standard intervention of pharmacist-led education.
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 months

Secondary outcomes (1)

  1. Diabetes knowledge improvement (scores in percentage)

    PICC improved diabetic knowledge scores (score above or equal to 80% up to 100% showing good knowledge)

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2021
  2. Study start1 May 2023
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05106231
Sponsor's protocol ID
NMRR-21-767-59240
Acronym
EPICCIHKDMEP
Status last verified
Feb 2024
First submitted
28 Sep 2021
Last updated
16 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data collection forms are not in codes. Site investigators and participants have access to individual case report forms because the information is transparent to those involved.

Publications

  • 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.

    PubMed 31077233

  • 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.

    PubMed 21772732

  • 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.

    PubMed 15707260

  • 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.

    PubMed 38435429

Questions about this trial

What is this clinical trial studying?

A study testing PICC Program in people with Diabetes Mellitus and Type2 Diabetes, run by Clinical Research Centre, Malaysia at 9 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

laboratory-analysed HbA1C improvement (HbA1c level below 42mmol/mol or 6.5%) (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05106231, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.

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