RecruitingNot ApplicableNCT06968650

Cocooned Moms Study

Efficacy of a Culturally-sensitive Telehealth Platform in Fostering Community-based Care Coordination for Respectful Maternal Care

Sponsor

InovCares Connected Comprehensive Healthcare Corporation

Enrollment

384 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Pregnancy Depression Stress Blood Pressure

Summary

The Cocooned Moms Study is a pre- and post-design study primarily aimed at reducing stress, depressive symptoms, and blood pressure among expectant Black women by providing them with free access to the InovCares mobile app. InovCares is a culturally-sensitive telehealth platform designed for community-based care coordination in maternal care. It also offers a culturally tailored maternal mental health program, which provides access to resources addressing social determinants of health, cognitive behavioral therapy (CBT), interpersonal therapy, and compassion-focused therapy (CFT), along with peer-to-peer support and gamification. The study will evaluate the impact of these interventions on reported stress levels, depressive symptoms, sleep quality, and blood pressure (BP) among Black pregnant women.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study — called the Cocooned Moms Study — is designed specifically for Black pregnant women and aims to understand and improve their maternal health experiences and outcomes through supportive, culturally responsive care. **You may be eligible if...** - You identify as a Black woman - You are 18 or older - You are currently pregnant (between 8 and 28 weeks along) - There are no known fetal genetic abnormalities (abnormal fluid levels are okay) - You are able to speak and understand English - You have the capacity to give informed consent **You may NOT be eligible if...** - You are fewer than 8 weeks or more than 28 weeks pregnant at enrollment - There are known significant fetal or genetic abnormalities - You are unable to understand English - You lack the legal or developmental capacity to consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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