Patient-centered Mobile Technology Interventions to Improve Maternal Health in Uganda

NCT04313348 | Completed DMC

• 1 other identifier: MUST 13/09-18
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Ugandan women and their children suffer from high maternal mortality (360 for every 100,000 women) and perinatal mortality (41 deaths per 1000 births). Only 58% of pregnant women attend at least 4 Antenatal Care (ANC) visits (of the recommended 8) and only 70% deliver with a skilled attendant. The design and evaluation of patient-centered, interventions to engage social support and improve utilization of ANC and skilled delivery services, with an overarching goal of improving maternal child health in lower-resourced settings.

Conditions

Maternal Child Health

Outcome Measures

Primary Outcomes (2)

• Feasibility of emobilize application

  Questionnaire to assess ability to utilize emobilize application, to open received message, read and understand it

  5 months

• Acceptability of emobilize application

  Acceptability will be measured using the Technology Acceptance Model (TAM) to assess ease-of-use, motivation, social influence, perceived control, attitude towards use of the technology, and its usefulness

  5 months

Secondary Outcomes (2)

• ANC attendance

  9months

• Skilled births

  9months

Study Arms (3)

Control Arm

ACTIVE COMPARATOR

Study participants in this arm will receive no SMS reminders nor social supporter notifications.

Behavioral: eMobilize-Uganda application

Intervention Arm 1

EXPERIMENTAL

Participants will receive an mHealth intervention targeted to the study participant (such as health information on an eMobilize-Uganda application or messaging and SMS reminders, or a voice call if at high risk). A weekly SMS reminder on the impending ANC appointment and expected date of delivery at their preferred time and day of the week will be sent to study participants. The content of the SMS reminders will be customized and determined by each individual at enrollment. If the participant has no preference, we will suggest "This is your ANC visit reminder, encouraging you to attend". This technology is already integrated and running in Uganda via the Yo! Uganda Gateway.

Behavioral: eMobilize-Uganda application

Intervention Arm 2

EXPERIMENTAL

Participants will receive an mhealth intervention targeted to the participant plus an intervention targeted to engage the social supporter. Study participants will receive health information and SMS reminders same as those of "scheduled SMS arm" above + weekly SMS notifications to the 2 pre-identified social supporters. Notifications will bear upcoming ANC visit and delivery due date for the study participant they are supporting for all the study follow-up period (also called the "social support engagement arm"). Social supporters will be able to personalize the SMS content at enrollment. They will be advised to assist study participants with any problems that may affect ANC attendance or facility delivery, but will not be given specific instructions on what to do.

Behavioral: eMobilize-Uganda application

Interventions

eMobilize-Uganda application BEHAVIORAL

Arm 1 is the "Control arm". Participants will receive no SMS reminders nor social supporter notifications. Arm 2, "Scheduled SMS arm": Will receive an mHealth intervention targeted to the study participant (such as health information on an eMobilize-Uganda CommCare application or messaging and SMS reminders, or a voice call if at high risk). A weekly SMS reminder on the impending ANC appointment and expected date of delivery will be sent to participants. The content of the SMS reminders will be customized at enrolment. Arm 3 "social support engagement arm": Will receive an mhealth intervention targeted to the participant plus an intervention targeted to engage the social supporter. Study participants will receive health information through the eMobilize-Uganda CommCare application or messaging + weekly SMS reminders + weekly SMS notifications to the 2 pre-identified social supporters. Notifications will bear upcoming ANC visit and delivery due date for all the study follow-up period.

Also known as: Same as above

Control Arm; Intervention Arm 1; Intervention Arm 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18 years and older, living in Mbarara district (within 20 km of the antenatal clinic), owning a cell phone for personal use with reliable cellular phone reception, able to give informed consent, and willing to identify at least two social supporters.

You may not qualify if:

• women with known high risk pregnancies classified as; hypertensive, history of gestational diabetes, history of pre-eclampsia or other severe birth complications.

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead
• Massachusetts General Hospital: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (1)

Mbarara Regional Referral Hospital

Mbarara, 0256, Uganda

Location

Related Publications (1)

• Atukunda EC, Siedner MJ, Obua C, Musiimenta A, Ware NC, Mugisha S, Najjuma JN, Mugyenyi GR, Matthews LT. Evaluating the Feasibility, Acceptability, and Preliminary Efficacy of SupportMoms-Uganda, an mHealth-Based Patient-Centered Social Support Intervention to Improve the Use of Maternity Services Among Pregnant Women in Rural Southwestern Uganda: Randomized Controlled Trial. JMIR Form Res. 2023 Mar 2;7:e36619. doi: 10.2196/36619.

  PMID: 36862461 DERIVED

MeSH Terms

Interventions

S-Adenosylmethionine

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Francis Bajunirwe, PhD

  Mbarara University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 18, 2020
• Study Start: August 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available after the study
• Access Criteria: Will be provided after publication

Locations

UG (1)