Community Health Worker Support for Preeclampsia
(AW2H Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Disqualifiers: Non-English speakers, Incarceration, Previous P3OPPY
No Placebo Group
Trial Summary
What is the purpose of this trial?United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia (PE) and other adverse pregnancy outcomes (APOs). Investigators will partner with a community-based organization that trains and deploys community health workers. Investigators will test an intervention for urban and rural Black postpartum patients with APOs to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment Community Health Worker Intervention for preeclampsia?
Research shows that community health workers can play a crucial role in managing preeclampsia by engaging with communities, facilitating early diagnosis, and referring women for further care, which can help reduce maternal and perinatal mortality.
12345Is the Community Health Worker Support for Preeclampsia generally safe for humans?
The research suggests that community health worker programs, including those using mobile health applications, are generally well-received and safe, as they improve interactions and support maternal health without reported safety concerns.
12367How does the Community Health Worker Intervention treatment for preeclampsia differ from other treatments?
The Community Health Worker Intervention for preeclampsia is unique because it involves community health workers who engage with the community to provide early diagnosis, stabilization, and referral for women with preeclampsia, especially in low-resource settings. This approach focuses on task-sharing and building trust-based relationships, which is different from traditional medical treatments that rely solely on healthcare facilities and professionals.
12468Eligibility Criteria
This trial is for Black individuals between the ages of 16-56 who are experiencing adverse pregnancy outcomes like preeclampsia, preterm birth, and others. Participants must be planning to deliver at UAB Hospital, speak and write English, and not be due for delivery at enrollment.Inclusion Criteria
I am between 16 and 56 years old.
Self Identifies as Black
Experiencing adverse pregnancy outcomes defined as hypertensive disorders of pregnancy, preterm birth, placental abruption, pregnancy loss (loss at greater or equal to 14 weeks gestation), gestational diabetes, delivering a small for gestational age infant
+2 more
Exclusion Criteria
I choose not to be randomly assigned to a treatment group.
Speaks or writes in languages other than English
Currently incarcerated
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants receive cardiovascular disease prevention education and community health worker support
12 weeks
Regular visits with community health workers
Follow-up
Participants are monitored for satisfaction and health outcomes, including blood pressure and primary care visit scheduling
6-12 weeks postpartum
Participant Groups
The study is testing if adding a community health worker intervention to usual postpartum care can better control blood pressure after childbirth and help prevent heart disease later on in Black patients with adverse pregnancy outcomes.
2Treatment groups
Experimental Treatment
Group I: Usual care and community health worker interventionExperimental Treatment2 Interventions
Usual postpartum care and community health worker visits and support
Group II: Usual CareExperimental Treatment1 Intervention
Usual postpartum care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Alabama at BirminghamBirmingham, AL
UAB MedicineBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
National Center for Advancing Translational Sciences (NCATS)Collaborator
American Heart AssociationCollaborator
National Institutes of Health (NIH)Collaborator
References
Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial. [2021]To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management.
Community health worker knowledge and management of pre-eclampsia in rural Karnataka State, India. [2018]In India, the hypertensive disorders of pregnancy and postpartum haemorrhage are responsible for nearly 40 % of all maternal deaths. Most of these deaths occur in primary health settings which frequently lack essential equipment and medication, are understaffed, and have limited or no access to specialist care. Community health care workers are regarded as essential providers of basic maternity care; and the quality of care they provide is dependent on the level of knowledge and skills they possess. However, there is limited research regarding their ability to manage pregnancy complications. This study aims to describe the current state of knowledge regarding pre-eclampsia and eclampsia among community health care workers (auxiliary nurse midwives, accredited social health activists, staff nurses) in northern Karnataka, India. Furthermore, this study describes the treatment approaches used by various cadres of community health workers for these conditions. The findings of this study can help plan focussed training sessions to build upon their strengths and to address the identified gaps.
Community Health Worker Evaluation of Implementing an mHealth Application to Support Maternal Health Care in Rural India. [2021]Introduction: PIERS on the Move (POM) is a mobile health (mHealth) application developed for a smartphone to support community health workers (CHWs) for identification and management of women at risk of adverse outcomes from pre-eclampsia. POM was implemented as an addition to routine antenatal care by accredited social health activists (ASHAs) and auxiliary nurse midwives (ANMs) during the community level intervention for pre-eclampsia (CLIP) Trial in Karnataka state, India (NCT01911494). The objective of this study was to evaluate the experiences of CHWs of using POM in rural India and their perceptions of acceptability and feasibility of this mHealth intervention. Methods: A posttrial mixed-methods evaluation was designed to measure CHW knowledge and self-efficacy regarding the care of women with pre-eclampsia and perceptions of CHWs on the ease of use and usefulness of POM. A structured survey with open-ended questions was conducted between October and November 2017. The median values on a 5-point Likert scale for knowledge and self-efficacy questions were compared between trial arms by Mann-Whitney U test (p < 0.05 significant). Qualitative analysis was undertaken on NVivo 12 (QSR International, Melbourne, Australia). Results: A total of 48 ASHAs and ANMs were interviewed, including 24 who used POM (intervention arm) and 24 who did not (control arm). Self-reported knowledge and self-efficacy for the care of women with pre-eclampsia did not differ between groups. The qualitative analysis highlighted that health workers who used POM reported improved interactions with women and families in their communities. POM strengthened the role of ASHA as a CHW beyond a "link-worker" accompanying women to health services. With training, the mHealth application was easy to use even for CHWs who did not have much experience with smartphones. Conclusions: Community health workers found the POM app easy to use, useful, and well-received by women and their families. POM did not improve care through increased knowledge but built capacity by increasing the recognition of the ASHA and ANM as critical members of the continuum of antenatal healthcare within their communities. These findings support the important role that mHealth technologies can play in strengthening health systems to reach rural, remote, and marginalized populations to reduce disparities in health.
Feasibility of task-sharing with community health workers for the identification, emergency management and referral of women with pre-eclampsia, in Mozambique. [2021]Maternal mortality is an important public health problem in low-income countries. Delays in reaching health facilities and insufficient health care professionals call for innovative community-level solutions. There is limited evidence on the role of community health workers in the management of pregnancy complications. This study aimed to describe the feasibility of task-sharing the initial screening and initiation of obstetric emergency care for pre-eclampsia/eclampsia from the primary healthcare providers to community health workers in Mozambique and document healthcare facility preparedness to respond to referrals.
Community health workers' knowledge and practice in relation to pre-eclampsia in Ogun State, Nigeria: an essential bridge to maternal survival. [2022]Pre-eclampsia is a leading cause of maternal and fetal morbidity and mortality worldwide. Early detection and treatment have been instrumental in reducing case fatality in high-income countries. To achieve this in a low-income country, like Nigeria, community health workers who man primary health centres must have adequate knowledge and skills to identify and provide emergency care for women with pre-eclampsia. This study aimed to determine community health workers' knowledge and practice in the identification and treatment of pre-eclampsia, as they are essential providers of maternal care services in Nigeria.
Features and Impact of Trust-Based Relationships Between Community Health Workers and Low-Resource Perinatal Women with Chronic Health Conditions. [2021]Community health worker (CHW) programs are a promising strategy to improve maternal and child health outcomes, particularly among low-resource women. Yet, little is known about which aspects of CHW-client relationships are most salient for promoting positive change. This paper examines features of the CHW-client relationship that perinatal women with chronic conditions reported as being beneficial for their experience of prenatal care and pregnancy.
Training and experience outperform literacy and formal education as predictors of community health worker knowledge and performance, results from Rongo sub-county, Kenya. [2023]There is a growing recognition that Community Health Workers are effective at improving health outcomes and expanding health access. However, the design elements that lead to high-quality Community Health Worker programing are relatively understudied. We looked at the predictors of Community Health Worker knowledge of obstetric and early infant danger signs as well as performance in achieving antenatal care and immunization uptake among their clients.
Effects of community health worker interventions on socioeconomic inequities in maternal and newborn health in low-income and middle-income countries: a mixed-methods systematic review. [2022]Community health worker (CHW) interventions are promoted to improve maternal and newborn health in low-income and middle-income countries. We reviewed the evidence on their effectiveness in reducing socioeconomic inequities in maternal and newborn health outcomes, how they achieve these effects, and contextual processes that shape these effects.