IMPACT OF DIABETES HEALTHCARE PROGRAM ON GLYCEMIC CONTROL AND SELF-EFFICACY AMONG TYPE-II DIABETICS IN ISLAMABAD PAKISTAN

NCT06719076 | Completed DMC

• 1 other identifier: 000574/HSA/MSPH-2023
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 Diabetes Mellitus (T2DM) is a significant public health challenge in Pakistan, characterized by a growing prevalence and substantial economic burden. The alarming rise in T2DM cases in Pakistan highlights the need for evidence-based solutions to control the disease. However, there is a notable knowledge gap in the effectiveness of diabetes healthcare program interventions in Pakistan. The goal of this randomized controlled trial (RCT) is to evaluate the effectiveness of a Diabetes Healthcare Program in improving glycemic control and enhancing Self-efficacy in Type-II Diabetic patients in Islamabad, Pakistan. The main questions it aims to answer are whether the Diabetes Healthcare Program can reduce HbA1c levels and enhance Self-efficacy in Type-II Diabetic patients. Researchers will compare the outcomes of 37 patients receiving the Diabetes Healthcare Program with 37 patients receiving standard care to see if the program improves glycemic control and enhances Self-efficacy. Participants will attend 12 weeks of Diabetes Healthcare Program sessions, receive standard care from the hospital's diabetes department, and complete surveys and questionnaires to assess their Self-efficacy and glycemic control at baseline and after the 3 months intervention period.

Conditions

HbA1c

Keywords

HBA1c levels; RCT Pakistan; Self-Efficacy; T2DM; Diabetes Mellitus; Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

• Change in Glycemic Control (HbA1c Levels)

  The HbA1c test is a widely used indicator of glycemic control, reflecting the average blood glucose concentration over the preceding 2-3 months. The level of HbA1c is influenced by the blood glucose concentration, the duration of red blood cell exposure to varying concentrations, and the quantity of red blood cells. The HbA1c test has been reviewed and validated in numerous studies (Sherwani et al., 2016). The score ranges from 5% to 15%, with a normal score of 5.7% or less, a prediabetes score of 5.8% to 6.4%, and a diabetes score of 6.5% or higher.

  The primary outcome will be measured at two time points: first at baseline and second after 3 months following the implementation of the intervention.

Secondary Outcomes (1)

• Enhance Self-efficacy

  The secondary outcome will be measured at two time points: first at baseline and second after 3 months following the implementation of the intervention.

Study Arms (2)

Diabetes Healthcare Program DHCP

EXPERIMENTAL

Type-II Diabetics in the intervention group will be received for 3 months of DHCP as well as usual care. Additional for session participation reminders messages will be sent 3 days before training and the messages will be forwarded by Principal Investigator and Research Assistant. Outcome variable will be measured at two points at the baseline and after completing of 3 months of intervention.

Behavioral: Diabetes Healthcare Program (DHCP)

No intervention arm

NO INTERVENTION

Type-II Diabetes in the control group will receive usual care, which includes routine consultations with physicians and pharmacological therapy as prescribed by healthcare provider. The frequency of clinic visits will be every 3 months, with monitoring of blood glucose levels, blood pressure, and lipid profiles. The usual care protocol is based on the guidelines for the management of type 2 diabetes mellitus by the American Diabetes Association (Care, 2023)

Interventions

Diabetes Healthcare Program (DHCP) BEHAVIORAL

Training for Type-II Diabetics The program includes 6 structured training sessions, each session will delivered biweekly and lasting for 1 hour and 20 minutes , covering topics such as: Week 1: Diabetes Education and Goal Setting Week 3: Nutrition and Meal Planning Week 5: Physical Activity and Exercise Week 7: Medication Management Week 9: Stress Management and Emotional Well-being Week 11: Review and Future Plans Time, Venue, and Interactive Activities Sessions will be held at the Federal General Hospital Basement, on Fridays, from 10:00 am to 11:20 am. Each session includes interactive elements, such as group discussions, practical exercises, and hands-on activities, to ensure participants are fully engaged and equipped to manage their T2DM diabetes.

Diabetes Healthcare Program DHCP

Eligibility Criteria

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

You may qualify if:

• Type-II Diabetes on follow-up treatment in FGH for last 6 months.
• Type-II Diabetic age 18 years and above of both genders.
• Type-II Diabetic with uncontrolled Diabetes whose HbA1c reading is \>7% at last assessment within 3 months
• Type-II Diabetic living in Islamabad.

You may not qualify if:

• Type-II Diabetic recognized as disabled and suffering from loss of hearing.
• Type-II Diabetics with serious complications such as retinopathy/kidney disease/tachycardia in a stable status \> 100/minute, or serious diabetic feet
• Type-II Diabetic currently using injection insulin impaired glucose tolerance, metabolic syndrome, maturity onset diabetes of youth and gestational diabetes

Sponsors & Collaborators

• Health Services Academy, Islamabad, Pakistan: lead

Study Sites (1)

Federal General Hospital

Islamabad, ICT, 44000, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: To maintain internal validity and minimize bias, randomization will be employed to allocate participants to either the control group or the Diabetes Healthcare Program group. A series of individually concealed envelopes will be prepared by an assistant not involved in the trial (Clark et al., 2021). Each bearing a randomly assigned indication of either "Control group" or "Diabetes Healthcare Program group" and sequentially numbered. Once a participant provides informed consent and meets the inclusion criteria, the next envelope in line will be opened to determine the group allocation, ensuring that randomization remains blinded to the research team until allocation is revealed. This approach adheres to the CONSORT guidelines, which recommend randomization in trials to avoid confounding variables and ensure comparability between groups (Schulz et al., 2010).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: In single group arm design the Type-II Diabetics randomized in two arms the first arm receive 3 months of DHCP intervention and other arm receive 3 month usual care. The allocation of groups assigned after the randomization either for intervention arm or control arm and the result will be compared and interpreted and disseminated.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 5, 2024
• Study Start: August 26, 2024
• Primary Completion: January 26, 2025
• Study Completion: January 31, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)