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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Telengana
-
Hyderabad, Telengana, Indie
- The George Institute for Global Health
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: 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.
|
|
Brak interwencji: Enhanced Standard Care
The control group will receive enhanced standard antenatal and postnatal care, involving:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Recruitment rate
Ramy czasowe: 12 months
|
Number of eligible pregnant women successfully recruited to study in 12 months.
|
12 months
|
|
Retention rate
Ramy czasowe: 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
Ramy czasowe: 12 months
|
Number of home visits completed by Community Health Worker using the SMARThealth Pregnancy mHealth platform in line with study protocol.
|
12 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of pregnant women diagnosed with gestational diabetes.
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 12 months
|
Haemoglobin values of postpartum women measured at 6 weeks postpartum.
|
12 months
|
|
Mean postpartum Systolic Blood Pressure
Ramy czasowe: 12 months
|
Systolic blood pressure of postpartum women measured at 6 weeks postpartum.
|
12 months
|
|
Mean postpartum Diastolic Blood Pressure
Ramy czasowe: 12 months
|
Diastolic blood pressure of postpartum women measured at 6 weeks postpartum.
|
12 months
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 22-19
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .