An mHealth Strategy to Reduce Pre-Eclampsia and Infant Death in Tanzania
Condition: Pre-Eclampsia; Eclampsia; Hypertension, Pregnancy-Induced
MeSH terms: Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional

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.
    


Intervention name(s): Community-based Pre-eclampsia/Eclampsia Detection and Management; Strengthened Referral Network from Community to Referral hospital levels
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Pre-eclampsia; Eclampsia; mHealth; mobile health; Gestosis; Hypertension, Pregnancy-Induced