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SMARThealth Pregnancy: Feasibility & Acceptability of a Complex Intervention for High-risk Pregnant Women in Rural India.

3 november 2020 bijgewerkt door: University of Oxford

SMARThealth Pregnancy: A Pilot Cluster Randomised Study to Assess Feasibility & Acceptability of a Complex Intervention Using Mobile Decision Support to Detect, Refer & Manage Pregnant Women at High Risk of Future Cardiometabolic Disorders in Rural India.

Background: Pregnancy-related conditions including hypertensive disorders of pregnancy (HDPs) and gestational diabetes mellitus (GDM) carry independent risks for future cardiovascular disease in women. Early identification, referral and management of pregnant women at increased risk of future cardiometabolic disorders may offer opportunities for prevention.

Objective: To determine the feasibility and acceptability of the SMARThealth Pregnancy intervention to improve the detection, referral and management of pregnant women at high-risk of future cardiometabolic disorders in rural India.

Study design: Cluster randomised pilot study of 4 primary care centres (PHCs) in two diverse areas of rural India.

Outcome: The primary objective of this pilot study is to address the feasibility of the SMARThealth Pregnancy intervention.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Background: Cardiovascular disease (CVD) is the leading cause of death in women in India, and the prevalence of cardiometabolic disorders is rising. Women in rural India (where two-thirds of the population live), are particularly vulnerable due to limited knowledge and healthcare access. Pregnancy-related conditions including hypertensive disorders of pregnancy (HDPs) and gestational diabetes mellitus (GDM) carry independent risks for future cardiovascular disease in women. Early identification, referral and management of pregnant women at increased risk of future cardiometabolic disorders may offer opportunities for prevention. Innovative solutions are required to address the needs of rural women, particularly during the transitions between antenatal and postpartum care and adult health services.

Objective: To determine the feasibility and acceptability of the SMARThealth Pregnancy intervention to improve the detection, referral and management of pregnant women at high-risk of future cardiometabolic disorders in rural India.

Study design: This is a pilot study, using an un-blinded, parallel group, cluster randomised controlled study design.

Study Sites: Jhajjar District, Haryana and Guntur District, Andhra Pradesh, India.

Primary outcome: The primary objective of this pilot study is to address the uncertainties around feasibility: (i) how many PHCs accepted the invitation to participate in a trial; (ii) whether the intervention is feasible with respect to participant recruitment rates, (iii) retention of pregnant women in the trial to 6 weeks postpartum; (iv) acceptability and feasibility of outcomes measures (to measure the efficacy within a definitive trial); (v) fidelity to the study protocol.

Secondary outcomes include: (i) Acceptability of the intervention. (ii) Process evaluation measures including rates of detection, referral and follow-up of high-risk pregnant women. (iii) Clinical outcomes of mean haemoglobin and mean systolic and diastolic blood pressures at 6 weeks postpartum.

Randomisation: Cluster randomisation will be conducted at the level of the PHC. Staff related to each PHC will be allocated to either intervention or control groups. The study will recruit 200 pregnant women across all 4 PHC clusters; 100 CHWs (known as ASHAs and ANMs) and; up to 8 Primary Care Physicians (affiliated to the PHC clusters). The villages selected under each intervention and control PHC will be non-contiguous to avoid contamination.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

258

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Indië
    • Telengana
      • Hyderabad, Telengana, Indië
        • The George Institute for Global Health

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Primary Health Centre cluster:

Inclusion Criteria:

  • PHC serving population of greater than 30,000 people.
  • Administrative lead for PHC consents for the PHC to participate in the study.

Exclusion Criteria:

  • Administrative lead does not give consent for the PHC to participate in the study.

Pregnant women:

Inclusion Criteria:

  • Age above 18 years.
  • Participant is recruited between 28-36 weeks gestation.
  • Participant is willing and able to give informed consent for participation in the study AND is:
  • Living in the villages affiliated to the PHC included in the study.

Exclusion Criteria:

  • Pregnant women who are younger than 18 years and;
  • Pregnant women who are not recruited between 28-36 weeks' gestation
  • Pregnant women not living in villages affiliated to the study PHCs will be excluded from the study.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: SMARThealth Pregnancy

The components of the SMARThealth Pregnancy intervention include:

  1. Educational and Training component on high-risk pregnancy conditions, focusing on; Anaemia, Hypertensive Disorders of Pregnancy (HDPs) and Gestational diabetes mellitus (GDM).
  2. An mHealth platform providing clinical decision support, lifestyle advice, recall and reminder system for Community Health Workers (CHWs) and Primary Care Physicians (PCPs).

Pregnant women in the intervention group will receive 3 visits at home by their CHW, in addition to their standard antenatal and postnatal care. One visit during the third trimester of pregnancy; one during Week 1 postpartum and; one visit during Week 6 postpartum.
Ander: SMARThealth Pregnancy
Education and Training package on high-risk pregnancies and the associated long-term cardiometabolic risks; An mHealth platform providing mobile decision support to Community Health Workers.
Geen tussenkomst: Enhanced Standard Care

The control group will receive enhanced standard antenatal and postnatal care, involving:

  1. An awareness programme for pregnant women, Community Health Workers (CHWs) and Primary Care Physicians (PCPs), held at the villages within the control group Primary Health Centre (PHC) cluster (Enhanced Standard Care). The community and health professionals will receive information on the high-risk conditions of anaemia in pregnancy, HDPs and GDM as part of the awareness programme.
  2. Standard antenatal and postnatal care (consisting of free monthly antenatal care, and up to 7 postnatal visits), delivered by CHWs in partnership with their PHC doctor.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recruitment rate
Tijdsspanne: 12 months
Number of eligible pregnant women successfully recruited to study in 12 months.
12 months
Retention rate
Tijdsspanne: 12 months
Number of eligible participants who remain in study for entire duration up to and including the 6 week postpartum visit.
12 months
Number of home visits completed by Community Health Worker
Tijdsspanne: 12 months
Number of home visits completed by Community Health Worker using the SMARThealth Pregnancy mHealth platform in line with study protocol.
12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of pregnant women diagnosed with gestational diabetes.
Tijdsspanne: 12 months
Number of participants correctly diagnosed with gestational diabetes mellitus using antenatal oral glucose tolerance test, in accordance with Government of India guidelines for Gestational Diabetes Mellitus, 2018.
12 months
Postpartum follow-up of pregnant women with gestational diabetes
Tijdsspanne: 18 months
Number of participants diagnosed with gestational diabetes who received postnatal 6 week oral glucose tolerance test, in accordance with Government of India guidelines for Gestational Diabetes Mellitus, 2018.
18 months
Number of pregnant women diagnosed with a hypertensive disorder of pregnancy.
Tijdsspanne: 12 months
Number of participants diagnosed with a hypertensive disorder of pregnancy using International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria.
12 months
Number of pregnant women diagnosed with severe anaemia.
Tijdsspanne: 12 months
Number of participants diagnosed with severe anaemia (haemoglobin of <7g/dL) during pregnancy, in accordance with Government of India guidelines for Anaemia, 2018.
12 months
Mean postpartum haemoglobin
Tijdsspanne: 12 months
Haemoglobin values of postpartum women measured at 6 weeks postpartum.
12 months
Mean postpartum Systolic Blood Pressure
Tijdsspanne: 12 months
Systolic blood pressure of postpartum women measured at 6 weeks postpartum.
12 months
Mean postpartum Diastolic Blood Pressure
Tijdsspanne: 12 months
Diastolic blood pressure of postpartum women measured at 6 weeks postpartum.
12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Oxford

Medewerkers

The George Institute

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 oktober 2019

Primaire voltooiing (Werkelijk)

14 september 2020

Studie voltooiing (Werkelijk)

1 november 2020

Studieregistratiedata

Eerst ingediend

23 mei 2019

Eerst ingediend dat voldeed aan de QC-criteria

28 mei 2019

Eerst geplaatst (Werkelijk)

30 mei 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2020

Laatste update ingediend die voldeed aan QC-criteria

3 november 2020

Laatst geverifieerd

1 november 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 22-19

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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