An mHealth Strategy to Reduce Pre-Eclampsia and Infant Death in Tanzania

Pre-Eclampsia Clinical Trial

Official title:

A Cluster Randomized, Parallel-group, Superiority Study to Compare the Effectiveness of a Community-based mHealth Strategy Versus Enhanced Usual Care in the Detection and Management of Pre-eclampsia/Eclampsia in Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03978429
• Other study ID #: 108022
• Status: Completed
• Phase: N/A
• Start date: August 31, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: December 2023
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The core of this study is a cluster randomized controlled trial (RCT) of antenatal clinics which are located in four districts in Tanzania. We are conducting an effectiveness (pragmatic) rather than an efficacy (explanatory) trial because we are looking to measure the degree of benefit under 'real world' conditions. Although pragmatic and carried out in real world conditions, the proposed size and scope of the trial will allow us to achieve a robust evaluation of outcomes and determine the effectiveness of our intervention. A cluster design is the most appropriate type of methodology (rather than individual randomization by pregnant woman) as the intervention can be delivered to the entire health facility (of those facilities in the intervention group). The intervention is to implement an mHealth strategy to improve detection and management of PE (pre-eclampsia). This study is a multi-level, mixed-methods design that includes a cluster-randomized controlled trial (RCT) of antenatal clinics in rural Tanzania. Thirty health facilities have been randomized to control facilities and thirty facilities have been randomized to intervention clinics. All randomized clinics have upgraded antenatal care (ANC) and skilled birth attendants present. Nurses in the intervention clinics in this cluster arm will receive mHealth-based education in detection and management of PE and will be instructed and encouraged to follow a guideline-driven approach supported by mHealth (educational modules that provide decision support and reminders through the facility smartphone/tablet). At all antenatal visits, pregnant women will have their blood pressures measured and urine assessed for proteinuria, and, the result will be automatically sent by SMS (short message service) with a unique patient identifier to a central site for monitoring and tracking. Community Health Workers (CHWs) linked to the facility site and local communities will be instructed on which women to have follow-up visits within their communities. For all those women found to be at risk for PE (as well as other high risk maternal conditions), an SMS will be sent to the CHW, and, the nurses at the ANC recommending timely follow-up and protocol steps for management at that facility or for transfer for further monitoring and management at a higher-level facility. The nurses participating in the study have been drawn from the health facilities themselves, in both control and intervention arms. Quantitative data will be collected on an ongoing basis through the mobile platform. Women are eligible for recruitment between 15 weeks and 36 weeks gestation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: July 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• at least 5 months pregnant

Exclusion Criteria:

• Unable to provide consent.

Related Conditions & MeSH terms

• Eclampsia
• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia

Intervention

Other:
• Community-based Pre-eclampsia/Eclampsia Detection and Management
Three Community Health Workers (CHWs) per health facility (cluster) will be equipped with android smartphones and blood pressure monitors. The CHWs will visit participant's home once per month until 6 weeks post-partum and complete a Case Report Form for signs and symptoms of pre-eclampsia and blood pressure. CHWs, Antenatal Care Nurses (ANC) at the woman's health facility and study coordinator will receive SMS message if the algorithm on our platform (informed by the Tanzanian Standard Treatment Guidelines (TSTG) deems she is at risk for pre-eclampsia. This message will indicate that the woman needs to be referred to her health facility if: participant has high blood pressure, a significant intrapatient rise in blood pressure or a combination of factors according to an algorithm. Woman's condition will be assessed and ANC will decide on the management, including rest at home with CHW monitoring. Women found to be at risk for pre-eclampsia will be visited twice monthly.
• Strengthened Referral Network from Community to Referral hospital levels
ANC nurses and CHWs will play complementary roles in performing activities to meet key indicators and facilitate referrals. They will deliver a plan using the Pre-eclampsia application tool on their smart phone and then they can refer the pregnant woman for enrollment for facility care and track them as per key indicators. The key innovation is that the mHealth platform can detect increases in BP within each patient, and this ability to detect is brought down to the community level through CHWs. This will allow for earlier detection of PE as singular BPs. Nurses will receive protocolized instructions and education regarding when to refer a woman to a higher-level facility for further management. The program consists of SMS component delivered to provide information about participant's condition to relevant members of the referral pathway to enhance referrals and facilitate community level follow up.

Locations

Country	Name	City	State
Tanzania	Ifakara Health Institute	Dar es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Karen Yeates	Ifakara Health Institute

Country where clinical trial is conducted

Tanzania, 

References & Publications (16)

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Maar MA, Yeates K, Toth Z, Barron M, Boesch L, Hua-Stewart D, Liu P, Perkins N, Sleeth J, Wabano MJ, Williamson P, Tobe SW. Unpacking the Black Box: A Formative Research Approach to the Development of Theory-Driven, Evidence-Based, and Culturally Safe Text Messages in Mobile Health Interventions. JMIR Mhealth Uhealth. 2016 Jan 22;4(1):e10. doi: 10.2196/mhealth.4994. — View Citation

Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC) [Tanzania, Mainland], Ministry of Health (MoH) [Zanzibar], National Bureau of Statistics (NBS), Office of the Chief & Government Statistician (OCGS), and ICF. Tanzania Demographic and Health Survey and Malaria Indicator Survey (TDHS-MIS) 2015-16. (MoHCDGEC, MoH, NBS, OCGS, and ICF, 2016).

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* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome (composite indicator reflecting activities associated with recognition and management/treatment of pre-eclampsia)	A composite indicator reflecting activities (1) associated with recognition of pre-eclampsia by recognizing 1 of these 4 items; Blood pressure reading greater than 140 mmHg, Diastolic greater than 90 mmHg, Intrapatient BP rise of 30mmHg systolic or 15mmHg diastolic, Proteinuria (+) and headache, visual disturbance or both and/or epigastric pain and vomiting, or both, or edema and (2)activities associated with the management/treatment of pre-eclampsia.	Outcome is evaluated at one month post delivery