search
Back to results

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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
mHealth Integrated Model of Antenatal Care
Sponsored by
Public Health Foundation of India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Gestational Diabetes Mellitus (GDM) focused on measuring Antenatal care, Pregnancy care, Pregnancy complications, Pregnancy Induced Hypertension, Gestational Diabetes Mellitus, Anemia

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

• 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)

Sites / Locations

  • Primary Health Centres (PHCs)
  • Primary Health Centres (PHCs)
  • Primary Health Centres
  • Primary Health Centres (PHCs)
  • Primary Health Centres (PHCs)
  • Health posts

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

Routine antenatal care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean number of the four selected ANC components delivered by the healthcare provider observed at the trial enrolment visit
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.
Mean number of the current pregnancy symptoms discussed with participants (either by the provider asking or the woman mentioning), observed over the two visits.
Symptoms include: nausea, vomiting, vaginal bleeding, severe headache, decreased or absent fetal movement, severe abdominal pain, blurred vision
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
Symptoms for which a response is expected from the provider: vomiting, vaginal bleeding, severe headache, decreased or absent foetal movement, severe abdominal pain or blurred vision or who were told that they had hypertension in pregnancy, GDM or anemia
Mean number of the danger signs mentioned to each participant by the healthcare provider for which she is advised to return for help
Danger signs include severe vomiting, vaginal bleeding, severe headache, decreased or no foetal movement, severe abdominal pain, blurred vision
Proportion of participants with clinical parameters indicative of PIH, GDM or severe anemia
Conditions diagnosed as: hypertension (SBP≥ 140 mmHg and DBP≥90 mmHg), GDM (venous blood glucose: fasting >92 mg/dL, 1 h OGTT (Oral Glucose Tolerance Test) >180 mg/dL, 2 h OGTT >153-199 mg/dL; glucometer test values: fasting >92 mg/dL, 1 h OGTT >198 mg/dL, 2 h OGTT >168 mg/dL) or severe anemia (<7g/dL)
Proportion of participants who were told by the provider that they had PIH, GDM or severe anemia
Conditions diagnosed as: hypertension (SBP≥ 140 mmHg and DBP≥90 mmHg), GDM (venous blood glucose: fasting >92 mg/dL, 1 h OGTT (Oral Glucose Tolerance Test) >180 mg/dL, 2 h OGTT >153-199 mg/dL; glucometer test values: fasting >92 mg/dL, 1 h OGTT >198 mg/dL, 2 h OGTT >168 mg/dL) or severe anemia (<7g/dL)
Mean number of quality antenatal care components delivered in the enrolment visit
The components are as follows: tests completed: blood pressure; blood glucose; urinary dipstick; hemoglobin tests Provider: symptom check: nausea; vomiting; vaginal bleeding; severe headache, decreased or absent foetal movement, severe abdominal pain, blurred vision warning about: severe vomiting; vaginal bleeding; severe headache; decreased or no foetal movement: severe abdominal pain; blurred vision counseling on diet enquiring about mental health recording ANC related information on the women-held MCP (Maternal and Chlid Protection) card

Full Information

First Posted
October 4, 2018
Last Updated
April 5, 2023
Sponsor
Public Health Foundation of India
Collaborators
London School of Hygiene and Tropical Medicine, Kathmandu University School of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT03700034
Brief Title
mHealth Integrated Model of Hypertension, Diabetes and Antenatal Care in India and Nepal
Official Title
A Cluster-randomized Trial of an mHealth Integrated Model of Hypertension, Diabetes and Antenatal Care in Primary Care Settings in India and Nepal
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Public Health Foundation of India
Collaborators
London School of Hygiene and Tropical Medicine, Kathmandu University School of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The cRCT aims to evaluate the effectiveness of a tablet-based EDSS in improving the quality of ANC and enhancing the detection and management of PIH, GDM, and anemia at primary care level health facilities in five districts of Telangana State: Medak, Rangareddy, Siddipet, Vikarabad, and Yadadri Bhuvangiri. The EDSS will use evidence-based algorithms to suggest recommendations to the FHWs for providing ANC, based on the pregnant woman's history, examination, and investigations, as well as incorporate reminders to ensure all relevant components of ANC are recorded. The aim is to ensure that ANC components received during multiple visits from multiple healthcare providers are captured and contribute to coordinated care. FHWs, primarily Auxiliary Nurse Midwives (ANMs), will use the EDSS during ANC consultations with pregnant women at Sub-Centres, while at the Primary Health Centres (PHCs), this will be used by Medical Officers (MOs) and staff nurses. In these selected districts, which are predominantly rural, 66 clusters with each cluster comprising a PHC and its two reporting Sub-Centres, will be randomized with a 1:1 allocation ratio to the intervention arm (providing ANC using the mIRA EDSS intervention) and the control arm (providing usual care), using a computer-generated randomization schedule stratified by the district. Covariate constrained randomization will be used to balance the arms on the following baseline covariates: the presence of a laboratory and laboratory technician (yes/no); more than three staff providing ANC (yes/no); facility type (PHCs that are open 24/7 or those not open 24/7). The cRCT will not be conducted In Nepal, however, the mIRA EDSS will be implemented at government Health Posts (HP), government Primary Health Care Centers (PHCCs), and Dhulikhel Hospital Outreach Centers (DHORCs), in four catchment districts (Kavrepalanchok, Sindhupalchowk, Sindhuli, and Dolakha) of Dhulikhel Hospital. A pre-post EDSS implementation outcome evaluation will be conducted. The process evaluation research activities conducted in India and Nepal will be the same (including a baseline facility survey, routine monitoring, and audit of record-keeping), except for a longitudinal case study and a time-motion study that will be conducted only in Nepal. Additionally, endline qualitative in-depth interviews with healthcare providers, facility managers, district and state health officials and policymakers, and with members of the Public Health Foundation of India team (intervention implementors) will be conducted only in India.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus (GDM), Pregnancy Induced Hypertension (PIH), Anemia
Keywords
Antenatal care, Pregnancy care, Pregnancy complications, Pregnancy Induced Hypertension, Gestational Diabetes Mellitus, Anemia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mHealth integrated model of hypertension, diabetes, anemia, and antenatal care
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine antenatal care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
mHealth Integrated Model of Antenatal Care
Other Intervention Name(s)
Electronic Decision Based System (EDSS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Secondary Outcome Measure Information:
Title
Mean number of the four selected ANC components delivered by the healthcare provider observed at the trial enrolment visit
Description
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.
Time Frame
Up to 28 weeks of gestation
Title
Mean number of the current pregnancy symptoms discussed with participants (either by the provider asking or the woman mentioning), observed over the two visits.
Description
Symptoms include: nausea, vomiting, vaginal bleeding, severe headache, decreased or absent fetal movement, severe abdominal pain, blurred vision
Time Frame
Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Title
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
Description
Symptoms for which a response is expected from the provider: vomiting, vaginal bleeding, severe headache, decreased or absent foetal movement, severe abdominal pain or blurred vision or who were told that they had hypertension in pregnancy, GDM or anemia
Time Frame
Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Title
Mean number of the danger signs mentioned to each participant by the healthcare provider for which she is advised to return for help
Description
Danger signs include severe vomiting, vaginal bleeding, severe headache, decreased or no foetal movement, severe abdominal pain, blurred vision
Time Frame
Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Title
Proportion of participants with clinical parameters indicative of PIH, GDM or severe anemia
Description
Conditions diagnosed as: hypertension (SBP≥ 140 mmHg and DBP≥90 mmHg), GDM (venous blood glucose: fasting >92 mg/dL, 1 h OGTT (Oral Glucose Tolerance Test) >180 mg/dL, 2 h OGTT >153-199 mg/dL; glucometer test values: fasting >92 mg/dL, 1 h OGTT >198 mg/dL, 2 h OGTT >168 mg/dL) or severe anemia (<7g/dL)
Time Frame
Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Title
Proportion of participants who were told by the provider that they had PIH, GDM or severe anemia
Description
Conditions diagnosed as: hypertension (SBP≥ 140 mmHg and DBP≥90 mmHg), GDM (venous blood glucose: fasting >92 mg/dL, 1 h OGTT (Oral Glucose Tolerance Test) >180 mg/dL, 2 h OGTT >153-199 mg/dL; glucometer test values: fasting >92 mg/dL, 1 h OGTT >198 mg/dL, 2 h OGTT >168 mg/dL) or severe anemia (<7g/dL)
Time Frame
Up to 28 weeks of gestation till the study completion with an average follow-up period of 3 months
Title
Mean number of quality antenatal care components delivered in the enrolment visit
Description
The components are as follows: tests completed: blood pressure; blood glucose; urinary dipstick; hemoglobin tests Provider: symptom check: nausea; vomiting; vaginal bleeding; severe headache, decreased or absent foetal movement, severe abdominal pain, blurred vision warning about: severe vomiting; vaginal bleeding; severe headache; decreased or no foetal movement: severe abdominal pain; blurred vision counseling on diet enquiring about mental health recording ANC related information on the women-held MCP (Maternal and Chlid Protection) card
Time Frame
Up to 28 weeks of gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: • 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sailesh Mohan, PhD
Phone
911244781400
Email
smohan@phfi.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorairaj Prabhakaran, DM
Organizational Affiliation
Vice President, Research and Policy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Health Centres (PHCs)
City
Medak
State/Province
Telangana
Country
India
Facility Name
Primary Health Centres (PHCs)
City
Rangareddy
State/Province
Telangana
Country
India
Facility Name
Primary Health Centres
City
Siddipet
State/Province
Telangana
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kalpana Basany, MD
Phone
08418256201
Email
kalpanabasany@gmail.com
Facility Name
Primary Health Centres (PHCs)
City
Vikarabad
State/Province
Telangana
Country
India
Facility Name
Primary Health Centres (PHCs)
City
Yadadri Bhuvnagiri
State/Province
Telangana
Country
India
Facility Name
Health posts
City
Dhulikhel
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs