An mHealth Strategy to Reduce Pre-Eclampsia and Infant Death in Tanzania
NCT ID: NCT03978429
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3000 participants
INTERVENTIONAL
2019-08-31
2020-07-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Intervention Arm
1. Community-based Pre-eclampsia/Eclampsia Detection and Management
2. Strengthened Referral Network from Community to Referral hospital levels
3. Antenatal Care Nurses will receive training on best practices for PE detection and management per Tanzanian Standard Treatment Guidelines.
4. Antenatal Care Nurses will be given smartphones and will be trained to complete Case Report Forms (CRF) to log key indicators and activities at each ANC visit, delivery and Postnatal Care visits of enrolled participants.
5. Antenatal Care Nurses will receive bluetooth blood pressure monitors.
6. Community Health Workers within the intervention arm facilities will receive training in pre-eclampsia features and will be provided with smart phones and access to a smart phone application that will prompt them to initiate follow ups with pregnant women within the community and they will receive SMS/text messages reminders about pregnant women within the community who require follow up.
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.
Enhanced Usual Care
1. Antenatal Care Nurses will receive training on best practices for PE detection and management per Tanzanian Standard Treatment Guidelines.
2. Antenatal Care Nurses will be given smartphones and will be trained to complete Case Report Forms (CRF) to log key indicators and activities at each ANC visit, delivery and Postnatal Care visits of enrolled participants.
3. Antenatal Care Nurses will receive bluetooth blood pressure monitors.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
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Ifakara Health Institute
OTHER
Dr. Karen Yeates
OTHER
Responsible Party
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Dr. Karen Yeates
Professor, Department of Medicince
Principal Investigators
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Karen E Yeates, MD
Role: PRINCIPAL_INVESTIGATOR
Queen's University
Locations
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Ifakara Health Institute
Dar es Salaam, , Tanzania
Countries
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References
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National Bureau of Statistics,. Tanzania Demographic and Health Survey (TDHS-MIS) 2010. (MoHCDGEC, MoH, NBS, OCGS, and ICF, 2010).
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).
The National Republic of Tanzania Ministry of Health, Community Development, Gender, Elderly and Children. Standard Treatment Guidelines & National Essential Medicines List. Fifth Edition. (2017).
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.
Rosenstock, I. M. The Health Belief Model and Preventive Health Behavior. Health Educ. Behav. 2, 354-386 (1974).
Jennings L, Gagliardi L. Influence of mHealth interventions on gender relations in developing countries: a systematic literature review. Int J Equity Health. 2013 Oct 16;12:85. doi: 10.1186/1475-9276-12-85.
Research in Gender and Ethics (RinGs). mHealth and Gender: Making the Connection. (2015).
Nie J, Unger JA, Thompson S, Hofstee M, Gu J, Mercer MA. Does mobile phone ownership predict better utilization of maternal and newborn health services? a cross-sectional study in Timor-Leste. BMC Pregnancy Childbirth. 2016 Jul 23;16(1):183. doi: 10.1186/s12884-016-0981-1.
GSMA Intelligence. Bridging the gender gap: Mobile access and usage in low- and middle-income countries. (2016).
GSMA Intelligence. Women and Mobile: A Global Opportunity.
Wesolowski A, Eagle N, Noor AM, Snow RW, Buckee CO. Heterogeneous mobile phone ownership and usage patterns in Kenya. PLoS One. 2012;7(4):e35319. doi: 10.1371/journal.pone.0035319. Epub 2012 Apr 25.
Blumenstock, J. & Eagle, N. Mobile divides: gender, socioeconomic status, and mobile phone use in Rwanda. in Proceedings of the 4th ACM/IEEE International Conference on Information and Communication Technologies and Development 6 (ACM, 2010).
GSMA mWomen. Striving and Surviving: Exploring the Lives of Women at the Base of the Pyramid. 1-74 (2012).
Chib A, Wilkin H, Ling LX, Hoefman B, Van Biejma H. You have an important message! Evaluating the effectiveness of a text message HIV/AIDS campaign in Northwest Uganda. J Health Commun. 2012;17 Suppl 1:146-57. doi: 10.1080/10810730.2011.649104.
Siedner MJ, Santorino D, Haberer JE, Bangsberg DR. Know your audience: predictors of success for a patient-centered texting app to augment linkage to HIV care in rural Uganda. J Med Internet Res. 2015 Mar 24;17(3):e78. doi: 10.2196/jmir.3859.
Eichler M, Burke MA. The BIAS FREE Framework: a new analytical tool for global health research. Can J Public Health. 2006 Jan-Feb;97(1):63-8. doi: 10.1007/BF03405218.
Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8(8):CD012739. doi: 10.1002/14651858.CD012739.pub2.
Other Identifiers
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108022
Identifier Type: -
Identifier Source: org_study_id