SMARThealth Pregnancy: Feasibility & Acceptability of a Complex Intervention for High-risk Pregnant Women in Rural India.
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Telengana
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Hyderabad, Telengana, Inde
- The George Institute for Global Health
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: SMARThealth Pregnancy
The components of the SMARThealth Pregnancy intervention include:
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. |
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.
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Aucune intervention: Enhanced Standard Care
The control group will receive enhanced standard antenatal and postnatal care, involving:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Recruitment rate
Délai: 12 months
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Number of eligible pregnant women successfully recruited to study in 12 months.
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12 months
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Retention rate
Délai: 12 months
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Number of eligible participants who remain in study for entire duration up to and including the 6 week postpartum visit.
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12 months
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Number of home visits completed by Community Health Worker
Délai: 12 months
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Number of home visits completed by Community Health Worker using the SMARThealth Pregnancy mHealth platform in line with study protocol.
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12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of pregnant women diagnosed with gestational diabetes.
Délai: 12 months
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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.
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12 months
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Postpartum follow-up of pregnant women with gestational diabetes
Délai: 18 months
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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.
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18 months
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Number of pregnant women diagnosed with a hypertensive disorder of pregnancy.
Délai: 12 months
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Number of participants diagnosed with a hypertensive disorder of pregnancy using International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria.
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12 months
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Number of pregnant women diagnosed with severe anaemia.
Délai: 12 months
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Number of participants diagnosed with severe anaemia (haemoglobin of <7g/dL) during pregnancy, in accordance with Government of India guidelines for Anaemia, 2018.
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12 months
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Mean postpartum haemoglobin
Délai: 12 months
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Haemoglobin values of postpartum women measured at 6 weeks postpartum.
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12 months
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Mean postpartum Systolic Blood Pressure
Délai: 12 months
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Systolic blood pressure of postpartum women measured at 6 weeks postpartum.
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12 months
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Mean postpartum Diastolic Blood Pressure
Délai: 12 months
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Diastolic blood pressure of postpartum women measured at 6 weeks postpartum.
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12 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 22-19
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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