mHealth Integrated Model of Hypertension, Diabetes and Antenatal Care in India and Nepal

NCT03700034 | Unknown

• 1 other identifier: CTRI/2019/01/016857
• Study Type: interventional
• Target: 1,320
• Locations: 2 countries
• Sites: 6

Brief Summary

Our research aims to address a critical gap in the provision of quality antenatal care (ANC) in India and Nepal, by developing and evaluating an intervention comprising of a tablet-based electronic decision support system (EDSS). This intervention -"mIRA" - is an mHealth integrated model of hypertension, diabetes, and antenatal care in primary care settings. mIRA aims to (a) prompt frontline health workers (FHWs) to provide evidence-based routine ANC, and also enhance the detection and management of Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anemia, whilst improving adherence to National ANC guidelines; (b) facilitate record-keeping and reporting and; (c) link providers across various levels of care to improve continuity of care. A cluster randomized controlled (cRCT) to assess the effectiveness of the mIRA EDSS in improving ANC and enhancing the detection and management of Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anemia will be conducted in Telangana, India. A mixed-methods process evaluation will be conducted in both India and Nepal. The process evaluation will contribute to our understanding of the mechanisms contributing to changes (improvement) in the quality of ANC by using the EDSS intervention.

Conditions

Gestational Diabetes Mellitus (GDM); Pregnancy Induced Hypertension (PIH); Anemia

Keywords

Antenatal care; Pregnancy care; Pregnancy complications; Pregnancy Induced Hypertension; Gestational Diabetes Mellitus; Anemia

Outcome Measures

Primary Outcomes (1)

• Mean number of four selected ANC components delivered by the healthcare providers per visit, observed over two visits- the trial enrolment visit and the next routine ANC appointment.

  This will be a composite score calculated as per the performance of the number of selected ANC components delivered or completed by the healthcare provider. The four selected components are: 1) the measurement and recording of systolic and diastolic blood pressure; 2) measurement of blood glucose, 3) performing urinary dipstick test for proteinuria and 4) conducting hemoglobin tests. The action of completing each of the aforementioned components by the healthcare provider will count as a score of one. Thus, completion of all four components will account to a score of four.

  Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months

Secondary Outcomes (7)

• Mean number of the four selected ANC components delivered by the healthcare provider observed at the trial enrolment visit

  Up to 28 weeks of gestation

• Mean number of the current pregnancy symptoms discussed with participants (either by the provider asking or the woman mentioning), observed over the two visits.

  Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months

• Proportion of providers who took the appropriate action (as defined by the EDSS) in response to aforementioned current pregnancy symptoms or who were told that they had hypertension in pregnancy, GDM or anemia

  Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months

• Mean number of the danger signs mentioned to each participant by the healthcare provider for which she is advised to return for help

  Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months

• Proportion of participants with clinical parameters indicative of PIH, GDM or severe anemia

  Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months

Study Arms (2)

mHealth integrated model of hypertension, diabetes, anemia, and antenatal care

EXPERIMENTAL

The mIRA trial intervention will consist of an electronic decision support system (EDSS), provided to healthcare providers at primary-level facilities in India and Nepal to deliver enhanced ANC with improved detection and management of pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM) and anemia.

Other: mHealth Integrated Model of Antenatal Care

Routine antenatal care

NO INTERVENTION

In the control clusters, pregnant women will receive the existing standard of care (usual care) from Frontline Health Workers (FHWs). Evidence-based guidelines in the form of posters/pamphlets on current national and state guidelines on screening and management of pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), anemia, and routine ANC procedures will be provided to all the control health facilities.

Interventions

mHealth Integrated Model of Antenatal Care OTHER

In the intervention facilities, antenatal care (ANC) will be provided to all pregnant women using the mIRA electronic decision support system (EDSS) by ANMs (Auxiliary Nurse Midwife), Staff nurses, or Medical Officers (MOs). These frontline healthcare workers (FHWs) will be trained to use the EDSS and will also be provided "refresher" training on the guideline-recommended processes of ANC. This training will enable them to use the mIRA EDSS in the provision of ANC. Non-physician FHWs (ANMs and staff nurses) will screen, detect, and refer PIH, GDM, and severe anemia cases. They will not prescribe treatments, but will carry out all other duties including diagnosis, referral to the MO to prescribe drugs, provide lifestyle advice, follow-up, and subsequently support adherence to management plans.

Also known as: Electronic Decision Based System (EDSS)

mHealth integrated model of hypertension, diabetes, anemia, and antenatal care

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women visiting a trial facility up to the end of the 28th week of gestation
• Women who are planning to remain within the five study districts until at least one-month post-partum OR women whose mothers reside in the selected districts

You may not qualify if:

• Women coming to the trial facility for a non-routine ANC visit (for example, to get a laboratory investigation, to collect a report or her medicine)

Sponsors & Collaborators

• Public Health Foundation of India: lead
• London School of Hygiene and Tropical Medicine: collaborator
• Kathmandu University School of Medical Sciences: collaborator

Study Sites (6)

Primary Health Centres (PHCs)

Medak, Telangana, India

Location

Primary Health Centres (PHCs)

Rangareddy, Telangana, India

Location

Primary Health Centres

Siddipet, Telangana, India

Location

Primary Health Centres (PHCs)

Vikārābād, Telangana, India

Location

Primary Health Centres (PHCs)

Yadadri Bhuvnagiri, Telangana, India

Location

Health posts

Dhulikhel, Nepal

Location

Related Publications (1)

• Mohan S, Chaudhry M, McCarthy O, Jarhyan P, Calvert C, Jindal D, Shakya R, Radovich E, Kondal D, Penn-Kekana L, Basany K, Roy A, Tandon N, Shrestha A, Shrestha A, Karmacharya B, Cairns J, Perel P, Campbell OMR, Prabhakaran D. A cluster randomized controlled trial of an electronic decision-support system to enhance antenatal care services in pregnancy at primary healthcare level in Telangana, India: trial protocol. BMC Pregnancy Childbirth. 2023 Jan 26;23(1):72. doi: 10.1186/s12884-022-05249-y.

  PMID: 36703109 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Hypertension, Pregnancy-Induced; Anemia; Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Dorairaj Prabhakaran, DM

  Vice President, Research and Policy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sailesh Mohan, PhD

CONTACT

911244781400; smohan@phfi.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President - Research and Policy

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: December 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1); IN (5)