Clinical trial NCT06719076: IMPACT OF DIABETES HEALTHCARE PROGRAM ON GLYCEMIC CONTROL AND SELF-EFFICACY AMONG TYPE-II DIABETICS IN ISLAMABAD PAKISTAN
Official title: IMPACT OF DIABETES HEALTHCARE PROGRAM ON GLYCEMIC CONTROL AND SELF-EFFICACY AMONG TYPE-II DIABETICS IN ISLAMABAD PAKISTAN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HbA1c
Keywords: HBA1c levels
RCT Pakistan
Self-Efficacy
T2DM
Diabetes Mellitus
Glucose Metabolism Disorders
Lead sponsor: Health Services Academy, Islamabad, Pakistan
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Detailed description: Objective: To evaluate the impact of Diabetes Healthcare Program on reducing HbA1c levels and enhance Self-efficacy 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: A total of 74 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 74 participants was met. Using random allocation, 37 subjects were assigned to the control group and 37 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 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Glycemic Control (HbA1c Levels)
timeFrame: 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:
measure: Enhance Self-efficacy
timeFrame: The secondary outcome will be measured at two time points: first at baseline and second after 3 months following the implementation of the intervention.
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Federal General Hospital
state: ICT
Study officials:
References: