Community Health Worker-Led Postpartum Diabetes Screening

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Gestational Diabetes; Diabetes Mellitus, Type 2

Treatments: Behavioral: Clinic Based Screening; Behavioral: Home Based Testing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06209411

22-11025408

1R01HD112141-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Referral Arm

Active Comparator group

Description:

CHW will contact participants with GDM from communities in the referral arm beginning at 6 weeks postpartum to arrange a convenient time for a home visit within the first postpartum year. During the home visit, CHW will provide 1) T2DM education and 2) referral to the postnatal clinic at a government hospital for T2DM screening.

Treatment:

Behavioral: Clinic Based Screening

Home Testing Arm

Experimental group

Description:

CHW will contact participants with GDM from communities in the home-based testing arm beginning at 6 weeks postpartum to arrange a convenient time for a home visit within the first postpartum year. During the home visit, CHW will provide 1) T2DM education, and 2) offer home-based OGTT.

Treatment:

Behavioral: Home Based Testing