HbA1cNCT06719076
IMPACT OF DIABETES HEALTHCARE PROGRAM ON GLYCEMIC CONTROL, SELF-EFFICACY AND DIABETES KNOWLEDGE AMONG TYPE-II DIABETICS IN ISLAMABAD PAKISTAN
A study testing Diabetes Healthcare Program (DHCP) in people with HbA1c and Self-Efficacy, run by Health Services Academy, Islamabad, Pakistan at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HbA1c, Self-Efficacy, Diabetes Knowledge
- What is being tested?
- Diabetes Healthcare Program (DHCP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Aug 2024to 28 Apr 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 >6.4% at last assessment within 3 months
- Type-II Diabetic living in Islamabad.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- HbA1c, Self-Efficacy, Diabetes Knowledge
- Being tested
- Diabetes Healthcare Program (DHCP)
- Keywords
- HBA1c levels, RCT Pakistan, Self-Efficacy, T2DM, Diabetes Mellitus, Glucose Metabolism Disorders, Diabetes Knowledge
- Medical subject headings
- Diabetes Mellitus, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Healthcare Program (DHCP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Healthcare Program DHCP | Experimental | 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: HbA1c level comprised the baseline and after a 3-month intervention period followed by a 4-month follow-up period.
Secondary outcomes (2)
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).
Measured: 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).
Measured: Diabetes knowledge comprised the baseline data and after a 3-month intervention period followed by a 4-month follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start26 Aug 2024
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HbA1cStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Services Academy, Islamabad, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul Samad, Health Services Academy, Islamabad, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719076
- Sponsor's protocol ID
- 000574/HSA/MSPH-2023
- Status last verified
- Jul 2026
- First submitted
- 26 Nov 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT OF DIABETES HEALTHCARE PROGRAM ON GLYCEMIC CONTROL, SELF-EFFICACY AND DIABETES KNOWLEDGE AMONG TYPE-II DIABETICS IN ISLAMABAD PAKISTAN
- ClinicalTrials.gov ID
- NCT06719076
- Acronym / sponsor ID
- 000574/HSA/MSPH-2023
- Conditions
- HbA1c, Self-Efficacy, Diabetes Knowledge
- Keywords
- HBA1c levels, RCT Pakistan, Self-Efficacy, T2DM, Diabetes Mellitus, Glucose Metabolism Disorders, Diabetes Knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Health Services Academy, Islamabad, PakistanUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diabetes Healthcare Program DHCP | Experimental | Behavioral: Diabetes Healthcare Program (DHCP)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. |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 >6.4% at last assessment within 3 months
- Type-II Diabetic living in Islamabad.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Healthcare Program (DHCP)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. | Behavioural | Diabetes Healthcare Program DHCP |
Primary outcome
Change in Glycemic Control (HbA1c Levels)
Time frame: HbA1c level comprised the baseline and after a 3-month intervention period followed by a 4-month follow-up period.
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.
2 secondary outcomes
Enhance Self-efficacy
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
Time frame: Diabetes knowledge comprised the baseline data and after a 3-month intervention period followed by a 4-month follow-up period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Healthcare Program (DHCP) in people with HbA1c and Self-Efficacy, run by Health Services Academy, Islamabad, Pakistan at 1 site in Pakistan.
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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
Change in Glycemic Control (HbA1c Levels) (time frame: HbA1c level comprised the baseline and after a 3-month intervention period followed by a 4-month follow-up period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.