An interventional study of Diabetes Healthcare Program (DHCP) in HbA1c, Self-Efficacy and Diabetes Knowledge, sponsored by Health Services Academy, Islamabad, Pakistan. Completed at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Health Services Academy, Islamabad, Pakistan · Not applicable, Interventional, and Treatment
Type-II Diabetes Mellitus 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 and diabetes knowledge in Type-II Diabetics in Islamabad, Pakistan. The main questions it aims to answer are whether the Diabetes Healthcare Program can reduce HbA1c levels and enhance Self-efficacy and diabetes knowledge in Type-II Diabetic patients. Researchers will compare the outcomes of 65 patients receiving the Diabetes Healthcare Program with 65 patients receiving standard care to see if the program improves glycemic control and enhances Self-efficacy and diabetes knowledge. 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.
Objective: To evaluate the impact of Diabetes Healthcare Program on reducing HbA1c levels, enhancing Self-efficacy and Diabetes Knowledge in Type-II Diabetics in Islamabad.
Setting, Duration, Study Type: The study was carried out as a randomized controlled trial (RCT) in Federal General Hospital Islamabad, which will be completed in 6 months. The study protocols was approved by ethical review board of Health Services Academy under letter no 000574/HSA/MSPH-2023 dated 23- Aug-2024. throughout the recruitment process.
Methods: Type-II Diabetics were invited to participate in the study, and those who visited the hospital underwent the recruitment process using a concealed envelop method. Recruitment was stopped once the required sample size of 128 participants was met. Using random allocation, 64 subjects were assigned to the control group and 64 to the intervention group. Both the control group and the intervention group received usual care delivered at FGH. The intervention group additionally received a Diabetes Health Care Program Intervention for 12-week duration.
Expected Outcome: The study aims to demonstrate that the Diabetes Healthcare Program (DHCP) intervention group will have enhanced Self-efficacy scores and diabetes knowledge and reduced HbA1c levels compared to the control group among Type-II Diabetics in Islamabad. If successful, the study's findings will be generalizable to similar settings worldwide, contributing significantly to the existing body of literature on improving glycemic control and Self-efficacy and diabetes knowledge in Type-II Diabetes. The study's results will have practical implications, informing policymakers on the development of evidence-based strategies to manage type II diabetes at a national level. This will ultimately enable the creation of targeted interventions and policies to improve the health outcomes of individuals with type II diabetes, contributing to global efforts to combat this growing health concern.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's enrollment of 128 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Health Services Academy, Islamabad, Pakistan is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Type-II Diabetics in the intervention group will be received for 3 months of DHCP followed by 4 months follow-ups 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 and followed for 4 months follow-ups.
Behavioral: Diabetes Healthcare Program (DHCP)
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)
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.
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.
Time frame: HbA1c level comprised the baseline and after a 3-month intervention period followed by a 4-month follow-up period.
Enhance Self-efficacy
Self-efficacy is a crucial component of Social Cognitive Theory in diabetes management. The Diabetes Management Self-efficacy Scale (DMSES) will be used to assess Self-efficacy in diabetes management. The DMSES measures confidence in conducting self-care activities, such as blood sugar monitoring, healthy eating, and physical activity. The scale ranges from 0 to 200, categorizing Self-efficacy into low (0-79), moderate (80-119), high (120-159), and very high (160-200). The Urdu version of the DMSES (U-DMSES) has been validated with moderate to strong psychometric properties (Bijl et al., 1999) (Riaz et al., 2017). The U-DMSES will be administered to participants to assess their Self-efficacy in managing Type-II Diabetes, informing interventions to enhance Self-efficacy and overall health and well-being (Luszczynska \& Schwarzer, 2015).
Time frame: Diabetes self-efficacy comprised the baseline data and after a 3-month intervention period followed by a 4-month follow-up period.
Diabetes Knowledge
Diabetes knowledge was assessed with the help of the 22-item Diabetes Knowledge Questionnaire-Revised (DKQ-R). The scores can vary from 0 to 22; high score reflects good diabetes knowledge (KR-20 = 0.77).
Time frame: Diabetes knowledge comprised the baseline data and after a 3-month intervention period followed by a 4-month follow-up period.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Aug 2024 to primary completion in Apr 2025, 8 months.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 8 months is below that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Health Services Academy, Islamabad, Pakistan