Clinical trial NCT06209411: Community Health Worker-Led Postpartum Diabetes Screening
Official title: A Type 2 Hybrid Effectiveness-Implementation Trial of Community Health Workers to Improve Screening for Postpartum Diabetes in Urban Slums of India
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Gestational Diabetes
Keywords: Community Health Workers
Type 2 Hybrid Effectiveness-Implementation Trial
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-01-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Trial
Primary purpose: SCREENING

Brief summary: Women who experience gestational diabetes are at high risk of developing type 2 diabetes mellitus in the postpartum period-especially in low- and middle-income countries like India where the burden of diabetes is high and disproportionately affects women- but few receive the World Health Organization-recommended postpartum diabetes screening test. The investigators propose a cluster randomized clinical trial to determine whether community health worker-administered, home-based testing increases uptake of postpartum diabetes screening in the urban slums of Pune, India. The proposed study will provide an acceptable and scalable model that can be used to improve postpartum diabetes screening in other low-income settings, thereby improving early detection of diabetes in women and preventing morbidity and mortality in this high-risk population.

Detailed description: The purpose of the project is to determine the effectiveness of a community health worker (CHW)-delivered home based oral glucose tolerance test (OGTT) (home testing arm) versus referral for clinic-based screening (referral arm) and evaluate the implementation of the CHW-delivered programs.

Design and Project Type: This hybrid type II effectiveness- implementation cluster randomized trial aims to evaluate if CHWs can improve postpartum type 2 diabetes mellitus (T2DM) screening in the urban slums of Pune, India. Slum communities will be randomized in equal number to one of two study arms. Participants in both arms will receive CHW-delivered OGTT during pregnancy to screen for GDM. For women diagnosed with gestational diabetes mellitus (GDM), the investigators will evaluate two strategies to improve T2DM screening in the first year postpartum: CHW-delivered home based OGTT (home testing arm) versus referral for clinic-based screening (referral arm).

Description of Intervention: The intervention is postpartum screening for T2DM which involves oral intake of a glucose load and subsequent measurement of fasting and postprandial point of care blood glucose measurement.

Eligibility criteria: Inclusion Criteria:

Pregnant Women:

* Pregnant woman residing in one of pre-selected slum communities
* 18 years or older
* ≥ 24 weeks gestational age (as determined by self-reported last menstrual period or ultrasound)
* Meet or exceed the threshold for GDM as determined by the CHW-delivered fasting OGTT
* Agrees to study procedures, including in-person visits with the CHW postpartum if they are diagnosed with GDM

Community Health Workers:

* 18 years or older
* Willingness to participate in study procedures and recruit eligible pregnant women
* Agreement with goals of the study
* Resides in one of the study communities
* Willing to participate in surveys and interviews

Clinicians:

* 18 years or older
* Diabetes or obstetrics physicians
* In a patient-facing position for over 1 year

Ministry of Health Officials

* 18 years or older
* Employed by the Ministry of Health and Family Welfare, Maternal Health Division

Exclusion Criteria:

Pregnant Women:

* Preexisting diabetes diagnosis prior to current pregnancy
* Unable to tolerate food/ drink and remain fasting for 8 hoursUnwilling or unable to participate in study procedures
* Unwilling or unable to provide informed consent

CHW, Clinicians, Ministry of Health Officials

1. Unwilling or unable to participate in study procedures
2. Unwilling or unable to provide informed consent

Primary outcomes:
measure: Number of participants who completed OGTT during the first year postpartum
timeFrame: Up to 1 year and 3 months
Secondary outcomes:
measure: Number of participants who accept OGTT screening for GDM during enrollment
timeFrame: Within 3 months of enrollment
measure: Number of participants with GDM who have abnormal postpartum OGTT results
timeFrame: Up to 1 year and 3 months
measure: Median time in months participants complete T2DM screening within the first 12 months postpartum.
timeFrame: Up to 1 year and 3 months
measure: Percentage of participants with abnormal OGTT who complete a single clinic visit for T2DM care
timeFrame: Up to 2 years
measure: Percentage of participants with abnormal OGTT who complete a second visit by 24 months postpartum
timeFrame: Up to 2 years
measure: Number of participants with any pregnancy complications, including high infant birthweight and presence of congenital anomalies.
timeFrame: Up to 5 months
measure: Number of women with abnormal OGTT who get tests including hemoglobin, lipid profile, creatinine.
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Pune
country: India
facility: Deep Griha Society
state: Maharashtra
Study officials:
affiliation: Weill Cornell Medicine Center for Global Health
name: Jyoti Mathad, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Cornell Medicine Center for Global Health
name: Radhika Sundararajan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: