The Effect of USM-IAM-based Counselling

NCT05125185 | Completed

• 1 other identifier: 304/PPSP/6315140
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

According to the most current local data, the rate of patient's adherence to insulin injections is very low. A recent cross sectional study in Klinik Pakar Perubatan (KPP) Hospital Universiti Sains Malaysia (HUSM) among 355 patients with Type 2 diabetes treated with insulin showed only 19% of patients adhered to their insulin regime with the mean fasting plasma glucose of 10mmol/L and mean HbA1C of 10.0%. This condition may lead to undesirable health consequences. Patients education has been showed to improved adherence. Among the 355 participants involved in the study, 82% of the patients have received consultation by diabetic educators yet their glycemic control were suboptimal. A new approaches using a module-based counseling that emphasized on adherence has been developed and the effectiveness of the counseling need to be evaluated.

Conditions

Diabetes Type 2 on Insulin

Outcome Measures

Primary Outcomes (8)

• Change of insulin adherence score

  Insulin adherence will be measured using an insulin adherence questionnaire for diabetes. change from mellitus. It contains 34 questions with minimum marks of 0 and a maximum of 100 marks. The higher the marks, the higher the degree of adherence. The patient is considered to adhere if they achieved marks of equal or more than 80

  3 months

• Change of insulin adherence score

  Insulin adherence will be measured using insulin adherence questionnaire for diabetes mellitus. it contains 34 questions with minimum marks of 0 and maximum of 100 marks. The higher the marks, the higher the degree of adherence. Patient is considered adherence if they achieved marks of equal or more than 80

  6 months

• Change of Fasting Blood Sugar

  change of FBS from baseline to 3 months

  3 months

• Change of Fasting Blood Sugar

  change of FBS from baseline to 6 months

  6 months

• Change of HbA1c

  change of HbA1c from baseline to 3 months

  3 months

• Change of HbA1c

  change of HbA1c from baseline to 6 months

  6 months

• Change of HsCRP

  change of HsCRP from baseline to 6 months

  6 months

• Change of VCAM-1

  change of baseline from baseline to 6 months

  6 months

Study Arms (2)

Standard Counseling

ACTIVE COMPARATOR

Trained diabetic educators educate patients using flip charts produced based on Malaysian Diabetes educators' manuals, insulin pen models and handouts. All patients were given SMBG diaries and encouraged to titrate their insulin dose based on SMBG

Other: The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation

USM-IAM- based counseling

EXPERIMENTAL

Trained diabetes educators counselled patients using the USM Insulin adherence module. Each patient was given the module so that they could freely refer to it when necessary. The module contains all information from standard counseling, with additional info on the definition of insulin non-adherence, causes of non-adherence, measures to overcome non-adherence and fasting safely with insulin. All patients were given SMBG diaries and encouraged to titrate their insulin dose based on SMBG

Other: The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation

Interventions

The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation OTHER

To study the effect of counseling using USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in improving Insulin Adherence, Glycemic Control and Inflammation

Standard Counseling; USM-IAM- based counseling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 to 65 years
• have been diagnosed with Type 2 Diabetes Mellitus
• Patients treated with insulin injections for at least 1 year on either basal insulin, basal plus prandial or basal bolus insulin
• HbA1c between 8 % and 15%

You may not qualify if:

• do not understand Malay language or illiterate
• have severe diabetes complications such as chronic kidney disease, heart failure
• recurrent hypoglycemia or hypoglycemia unawareness
• body mass index (BMI) ≥ 40kg/m2

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Related Publications (1)

• Zainudin AM, Rasool AHG, Yaacob NM, Muhamad R, Mohamed WMIW. The effect of USM-IAM-based counselling vs standard counselling on insulin adherence, FBS and HbA1c among patients with uncontrolled type 2 diabetes mellitus (T2DM): a randomised controlled trial. BMC Endocr Disord. 2024 Jul 18;24(1):118. doi: 10.1186/s12902-024-01577-6.

  PMID: 39020348 DERIVED

MeSH Terms

Interventions

Glycemic Control

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Aida Maziha Zainudin

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: comparing effect of counseling to insulin adherence, FBS, HbA1c, HsCRP and VCAM-1

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 18, 2021
• Study Start: August 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

MY (1)