SMARThealth Pregnancy: Feasibility & Acceptability of a Complex Intervention for High-risk Pregnant Women in Rural India.
NCT ID: NCT03968952
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
258 participants
INTERVENTIONAL
2019-10-01
2020-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Administrative lead for PHC consents for the PHC to participate in the study.
* 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:
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The George Institute
OTHER
University of Oxford
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The George Institute for Global Health
Hyderabad, Telangana, India
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Nagraj S, Kennedy S, Jha V, Norton R, Hinton L, Billot L, Rajan E, Mohammed Abdul A, Phalswal A, Arora V, Praveen D, Hirst J. A Mobile Clinical Decision Support System for High-Risk Pregnant Women in Rural India (SMARThealth Pregnancy): Pilot Cluster Randomized Controlled Trial. JMIR Form Res. 2023 Jul 20;7:e44362. doi: 10.2196/44362.
Nagraj S, Kennedy SH, Jha V, Norton R, Hinton L, Billot L, Rajan E, Arora V, Praveen D, Hirst JE. SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial. Front Glob Womens Health. 2021 May 28;2:620759. doi: 10.3389/fgwh.2021.620759. eCollection 2021.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22-19
Identifier Type: -
Identifier Source: org_study_id