المؤلفون: Hirst JE; Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK. jane.hirst@wrh.ox.ac.uk.; The George Institute for Global Health, Imperial College London, London, UK. jane.hirst@wrh.ox.ac.uk., Votruba N; Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK.; The George Institute for Global Health, Imperial College London, London, UK., Billot L; The George Institute for Global Health, University of New South Wales, Kensington, Australia., Arora V; PGIMS Rohtak, Haryana, India., Rajan E; The George Institute for Global Health, New Delhi, India., Thout SR; The George Institute for Global Health, New Delhi, India., Peiris D; The George Institute for Global Health, Newtown, Australia., Patel A; The George Institute for Global Health, University of New South Wales, Kensington, Australia., Norton R; The George Institute for Global Health, Imperial College London, London, UK.; The George Institute for Global Health, University of New South Wales, Kensington, Australia., Mullins E; The George Institute for Global Health, Imperial College London, London, UK., Sharma A; Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK., Kennedy S; Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK., Jha V; The George Institute for Global Health, New Delhi, India.; University of New South Wales, Kensington, Australia.; Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India., Praveen D; The George Institute for Global Health, New Delhi, India.; University of New South Wales, Kensington, Australia.; Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India.

المصدر: Trials [Trials] 2023 Aug 09; Vol. 24 (1), pp. 510. Date of Electronic Publication: 2023 Aug 09.

نوع المنشور: Clinical Trial Protocol; Journal Article

بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

مواضيع طبية MeSH: Anemia*/diagnosis , Anemia*/prevention & control , Diabetes, Gestational* , Hypertension* , Noncommunicable Diseases*/epidemiology , Noncommunicable Diseases*/prevention & control, Female ; Humans ; Pregnancy ; Follow-Up Studies ; India ; Postpartum Period ; Referral and Consultation ; Randomized Controlled Trials as Topic

مستخلص: Background: Medical complications during pregnancy, including anaemia, gestational diabetes mellitus and hypertensive disorders of pregnancy place women are at higher risk of long-term complications. Scalable and low-cost strategies to integrate non-communicable disease screening into pregnancy care are needed. We aim to determine the effectiveness and implementation components of a community-based, digitally enabled approach, "SMARThealth Pregnancy," to improve health during pregnancy and the first year after birth.
Methods: A pragmatic, parallel-group, cluster randomised, type 2 hybrid effectiveness-implementation trial of a community-based, complex intervention in rural India to decrease anaemia (primary outcome, defined as haemoglobin < 12g/dL) and increase testing for haemoglobin, glucose and blood pressure (secondary outcomes) in the first year after birth. Primary Health Centres (PHCs) are the unit of randomisation. PHCs are eligible with (1) > 1 medical officer and > 2 community health workers; and (2) capability to administer intravenous iron sucrose. Thirty PHCs in Telangana and Haryana will be randomised 1:1 using a matched-pair design accounting for cluster size and distance from the regional centre. The intervention comprises (i) an education programme for community health workers and PHC doctors; (ii) the SMARThealth Pregnancy app for health workers to support community-based screening, referral and follow-up of high-risk cases; (iii) a dashboard for PHC doctors to monitor high-risk women in the community; (iv) supply chain monitoring for consumables and medications and (v) stakeholder engagement to co-develop implementation and sustainability pathways. The comparator is usual care with additional health worker education. Secondary outcomes include implementation outcomes assessed by the RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance), clinical endpoints (anaemia, diabetes, hypertension), clinical service delivery indicators (quality of care score), mental health and lactation practice (PHQ9, GAD7, EuroQoL-5D, WHO IYCF questionnaire).
Discussion: Engaging women with screening after a high-risk pregnancy is a challenge and has been highlighted as a missed opportunity for the prevention of non-communicable diseases. The SMARThealth Pregnancy trial is powered for the primary outcome and will address gaps in the evidence around how pregnancy can be used as an opportunity to improve women's lifelong health. If successful, this approach could improve the health of women living in resource-limited settings around the world.
Trial Registration: ClinicalTrials.gov NCT05752955. Date of registration 3 March 2023.
(© 2023. BioMed Central Ltd., part of Springer Nature.)

المؤلفون: Vousden N; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, SE1 7EH, UK. Nicola.vousden@kcl.ac.uk., Lawley E; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, SE1 7EH, UK., Nathan HL; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, SE1 7EH, UK., Seed PT; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, SE1 7EH, UK., Brown A; Maternity Worldwide Community Base, 113 Queens Road, Brighton, BN1 3XG, UK., Muchengwa T; Morgenster Mission Hospital, Masvingo, Zimbabwe., Charantimath U; Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, 590010, India., Bellad M; Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, 590010, India., Gidiri MF; Department of Obstetrics and Gynaecology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe., Goudar S; Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, 590010, India., Chappell LC; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, SE1 7EH, UK., Sandall J; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, SE1 7EH, UK., Shennan AH; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, SE1 7EH, UK.

مؤلفون مشاركون: CRADLE Trial Collaborative Group

المصدر: BMC pregnancy and childbirth [BMC Pregnancy Childbirth] 2018 Apr 27; Vol. 18 (1), pp. 115. Date of Electronic Publication: 2018 Apr 27.

نوع المنشور: Evaluation Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't

بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 100967799 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2393 (Electronic) Linking ISSN: 14712393 NLM ISO Abbreviation: BMC Pregnancy Childbirth Subsets: MEDLINE

مواضيع طبية MeSH: Health Plan Implementation* , Randomized Controlled Trials as Topic*, Diagnostic Techniques, Obstetrical and Gynecological/*instrumentation , Health Personnel/*psychology , Maternal Death/*prevention & control, Decision Support Systems, Clinical ; Ethiopia ; Feasibility Studies ; Female ; Focus Groups ; Health Resources ; Humans ; India ; Monitoring, Physiologic ; Pregnancy ; Qualitative Research ; Referral and Consultation ; Research Design ; Surveys and Questionnaires ; Vital Signs ; Zimbabwe

مستخلص: Background: The CRADLE-3 trial is a stepped-wedge randomised controlled trial aiming to reduce maternal mortality and morbidity by implementing a novel vital sign device (CRADLE Vital Sign Alert) and training package into routine maternity care in 10 low-income sites. The MRC Guidance on complex interventions proposes that interventions and implementation strategies be shaped by early phase piloting and development work. We present the findings of a three-month mixed-methodology feasibility study for this trial, describe how this was informed by the MRC guidance and the study design was refined.
Methods: The fidelity, dose, feasibility and acceptability of implementation and training materials were assessed in three representative non-trial sites (Zimbabwe, Ethiopia, India) using multiple-choice questionnaires, evaluation of clinical management (action log), healthcare provider (HCP) semi-structured interviews and focus groups 4-10 weeks after implementation. Simultaneously, the 10 sites included in the main trial (eight countries) collected primary outcome data to inform the power calculation and randomisation allocation and assess the feasibility of data collection.
Results: The package was implemented with high fidelity (85% of HCP trained, n = 204). The questionnaires indicated a good understanding of device use with 75% of participants scoring > 75% (n = 97; 90% of those distributed). Action logs were inconsistently completed but indicated that the majority of HCP responded appropriately to abnormal results. From 18 HCP interviews and two focus groups it was widely reported that the intervention improved capacity to make clinical decisions, escalate care and make appropriate referrals. Nine of the ten main trial sites achieved ethical approval for pilot data collection. Intensive care was an inconsistent marker of morbidity and stroke an infrequent outcome and therefore they were removed from the main trial composite outcome. Tools and methods of data collection were optimized and event rates used to inform randomisation.
Conclusions: This feasibility study demonstrates that the components of the intervention were acceptable, methods of implementing were successful and the main trial design would be feasible. Qualitative work identified key moderators that informed the main trial process evaluation. Changes to the training package, implementation strategy, study design and processes were identified to refine the implementation in the main trial.
Trial Registration: ISRCTN41244132 ; Registered 24/11/2015.

المؤلفون: Nathan HL; Department of Women and Children's Health, King's College London, London, UK., Duhig K; Department of Women and Children's Health, King's College London, London, UK., Vousden N; Department of Women and Children's Health, King's College London, London, UK., Lawley E; Department of Women and Children's Health, King's College London, London, UK., Seed PT; Department of Women and Children's Health, King's College London, London, UK., Sandall J; Department of Women and Children's Health, King's College London, London, UK., Bellad MB; Department of Obstetrics and Gynaecology, KLE University's JN Medical College, Belgaum, Karnataka, India., Brown AC; Maternity Worldwide, Community Base, 113 Queens Rd, Brighton, UK., Chappell LC; Department of Women and Children's Health, King's College London, London, UK., Goudar SS; Department of Obstetrics and Gynaecology, KLE University's JN Medical College, Belgaum, Karnataka, India., Gidiri MF; Department of Obstetrics and Gynaecology, University of Zimbabwe, Harare, Zimbabwe., Shennan AH; Department of Women and Children's Health, King's College London, London, UK. andrew.shennan@kcl.ac.uk.

مؤلفون مشاركون: CRADLE-3 Trial Collaboration Group

المصدر: Trials [Trials] 2018 Mar 27; Vol. 19 (1), pp. 206. Date of Electronic Publication: 2018 Mar 27.

نوع المنشور: Clinical Trial Protocol; Journal Article

بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

مواضيع طبية MeSH: Blood Pressure* , Clinical Alarms*/economics , Developing Countries*/economics, Blood Pressure Determination/*instrumentation , Hypertension, Pregnancy-Induced/*diagnosis , Shock, Cardiogenic/*diagnosis, Africa ; Blood Pressure Determination/economics ; Cost-Benefit Analysis ; Equipment Design ; Female ; Haiti ; Health Care Costs ; Humans ; Hypertension, Pregnancy-Induced/mortality ; Hypertension, Pregnancy-Induced/physiopathology ; Hypertension, Pregnancy-Induced/therapy ; India ; Maternal Mortality ; Multicenter Studies as Topic ; Pragmatic Clinical Trials as Topic ; Predictive Value of Tests ; Pregnancy ; Risk Factors ; Shock, Cardiogenic/mortality ; Shock, Cardiogenic/physiopathology ; Shock, Cardiogenic/therapy ; Treatment Outcome

مستخلص: Background: Obstetric haemorrhage, sepsis and pregnancy hypertension account for more than 50% of maternal deaths worldwide. Early detection and effective management of these conditions relies on vital signs. The Microlife® CRADLE Vital Sign Alert (VSA) is an easy-to-use, accurate device that measures blood pressure and pulse. It incorporates a traffic-light early warning system that alerts all levels of healthcare provider to the need for escalation of care in women with obstetric haemorrhage, sepsis or pregnancy hypertension, thereby aiding early recognition of haemodynamic instability and preventing maternal mortality and morbidity. The aim of the trial was to determine whether implementation of the CRADLE intervention (the Microlife® CRADLE VSA device and CRADLE training package) into routine maternity care in place of existing equipment will reduce a composite outcome of maternal mortality and morbidity in low- and middle-income country populations.
Methods: The CRADLE-3 trial was a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care. Each cluster crossed from routine maternity care to the intervention at 2-monthly intervals over the course of 20 months (April 2016 to November 2017). All women identified as pregnant or within 6 weeks postpartum, presenting for maternity care in cluster catchment areas were eligible to participate. Primary outcome data (composite of maternal death, eclampsia and emergency hysterectomy per 10,000 deliveries) were collected at 10 clusters (Gokak, Belgaum, India; Harare, Zimbabwe; Ndola, Zambia; Lusaka, Zambia; Free Town, Sierra Leone; Mbale, Uganda; Kampala, Uganda; Cap Haitien, Haiti; South West, Malawi; Addis Ababa, Ethiopia). This trial was informed by the Medical Research Council guidance for complex interventions. A process evaluation was undertaken to evaluate implementation in each site and a cost-effectiveness evaluation will be undertaken.
Discussion: All aspects of this protocol have been evaluated in a feasibility study, with subsequent optimisation of the intervention. This trial will demonstrate the potential impact of the CRADLE intervention on reducing maternal mortality and morbidity in low-resource settings. It is anticipated that the relatively low cost of the intervention and ease of integration into existing health systems will be of significant interest to local, national and international health policy-makers.
Trial Registration: ISCRTN41244132. Registered on 2 February 2016. Prospective protocol modifications have been recorded and were communicated to the Ethics Committees and Trials Committees. The adapted Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist and the SPIRIT Checklist are attached as Additional file 1.

المؤلفون: Jindal D; a Clinical Trials , Centre for Chronic Disease Control (CCDC) , New Delhi , India., Gupta P; a Clinical Trials , Centre for Chronic Disease Control (CCDC) , New Delhi , India., Jha D; a Clinical Trials , Centre for Chronic Disease Control (CCDC) , New Delhi , India., Ajay VS; b Centre for Control of Chronic Conditions , Public Health Foundation of India , New Delhi , India., Goenka S; b Centre for Control of Chronic Conditions , Public Health Foundation of India , New Delhi , India., Jacob P; b Centre for Control of Chronic Conditions , Public Health Foundation of India , New Delhi , India., Mehrotra K; c Global Services , Dimagi Software Innovations Pvt. Ltd , New Delhi , India., Perel P; d Centre for Global Non Communicable Diseases , London School of Hygiene & Tropical Medicine , London , United Kingdom., Nyong J; d Centre for Global Non Communicable Diseases , London School of Hygiene & Tropical Medicine , London , United Kingdom., Roy A; e Centre for Control of Chronic Conditions , All India Institute of Medical Science, New Delhi , New Delhi , India., Tandon N; e Centre for Control of Chronic Conditions , All India Institute of Medical Science, New Delhi , New Delhi , India., Prabhakaran D; b Centre for Control of Chronic Conditions , Public Health Foundation of India , New Delhi , India., Patel V; f Department of Global Health and Social Medicine , Harvard Medical School , Boston , MA , USA.

المصدر: Global health action [Glob Health Action] 2018; Vol. 11 (1), pp. 1517930.

نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't

بيانات الدورية: Publisher: Taylor & Francis Country of Publication: United States NLM ID: 101496665 Publication Model: Print Cited Medium: Internet ISSN: 1654-9880 (Electronic) Linking ISSN: 16549880 NLM ISO Abbreviation: Glob Health Action Subsets: MEDLINE

مواضيع طبية MeSH: Cardiovascular Diseases/*therapy , Diabetes Mellitus/*therapy , Primary Health Care/*organization & administration , Telemedicine/*organization & administration, Adult ; Aged ; Algorithms ; Chronic Disease ; Female ; Humans ; India ; Male ; Middle Aged ; Monitoring, Ambulatory ; Patient Compliance

مستخلص: Background: Cardiovascular diseases and diabetes are among the leading causes of premature adult deaths in India. Innovative approaches such as clinical decision support (CDS) software could play a major role in improving the quality of hypertension/diabetes care in primary care settings.
Objective: To describe the steps and processes in the development of mWellcare, a complex intervention based on mobile health (mHealth) technology.
Methods: The Medical Research Council framework was used to develop mWellcare in four steps: (1) identify gaps in usual care through literature review and health facility assessments; (2) identify the components of the intervention through discussions and consultations with experts; (3) develop intervention (clinical algorithms and mHealth system); and (4) evaluate acceptability and feasibility through pilot testing in five community health centers.
Results: Lack of evidence-based, integrated, and systematic management of chronic conditions were major gaps identified. Experts in information technology, clinical fields, and public health professionals identified intervention components to address these gaps. Thereafter, clinical algorithm contextualized to primary care settings were prepared and the mWellcare intervention was developed. During the 2-month pilot, 631 patients diagnosed with hypertension and/or diabetes were registered, with a follow-up rate of 36.2%. The major barrier was resistance to follow mWellcare recommended patient workflow, and to overcome it, we emphasized onsite training and orientation program to cover all health care team member in each CHC.
Conclusion: A pilot-tested mWellcare intervention is an mHealth system with important components, i.e. integrated management of chronic conditions, evidence-based CDS, longitudinal health data and automated short-messaging service to reinforce compliance to drug intake and follow-up visit, which will be used by nurses at primary health care settings in India. The effectiveness and cost-effectiveness of the intervention will be tested through a cluster randomized trial (trial registration number NCT02480062).

المؤلفون: Modi D; Community Health Department, SEWA Rural, Bharuch, Gujarat, India., Gopalan R; Argusoft India Ltd., Gandhinagar, Gujarat, India., Shah S; Community Health Department, SEWA Rural, Bharuch, Gujarat, India., Venkatraman S; Argusoft India Ltd., Gandhinagar, Gujarat, India., Desai G; Community Health Department, SEWA Rural, Bharuch, Gujarat, India., Desai S; Community Health Department, SEWA Rural, Bharuch, Gujarat, India; sdesai1977@yahoo.com., Shah P; Community Health Department, SEWA Rural, Bharuch, Gujarat, India.

المصدر: Global health action [Glob Health Action] 2015 Feb 16; Vol. 8, pp. 26769. Date of Electronic Publication: 2015 Feb 16 (Print Publication: 2015).

نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't

بيانات الدورية: Publisher: Taylor & Francis Country of Publication: United States NLM ID: 101496665 Publication Model: eCollection Cited Medium: Internet ISSN: 1654-9880 (Electronic) Linking ISSN: 16549880 NLM ISO Abbreviation: Glob Health Action Subsets: MEDLINE

مواضيع طبية MeSH: Mobile Applications*, Child Health Services/*organization & administration , Community Health Workers/*organization & administration , Maternal Health Services/*organization & administration , Rural Health Services/*organization & administration , Telemedicine/*organization & administration, Child ; Developing Countries ; Health Behavior ; Health Education ; Health Services Accessibility ; Humans ; India ; Inservice Training

مستخلص: Background: A new cadre of village-based frontline health workers, called Accredited Social Health Activists (ASHAs), was created in India. However, coverage of selected community-based maternal, newborn and child health (MNCH) services remains low.
Objective: This article describes the process of development and formative evaluation of a complex mHealth intervention (ImTeCHO) to increase the coverage of proven MNCH services in rural India by improving the performance of ASHAs.
Design: The Medical Research Council (MRC) framework for developing complex interventions was used. Gaps were identified in the usual care provided by ASHAs, based on a literature search, and SEWA Rural's1 three decades of grassroots experience. The components of the intervention (mHealth strategies) were designed to overcome the gaps in care. The intervention, in the form of the ImTeCHO mobile phone and web application, along with the delivery model, was developed to incorporate these mHealth strategies. The intervention was piloted through 45 ASHAs among 45 villages in Gujarat (population: 45,000) over 7 months in 2013 to assess the acceptability, feasibility, and usefulness of the intervention and to identify barriers to its delivery.
Results: Inadequate supervision and support to ASHAs were noted as a gap in usual care, resulting in low coverage of selected MNCH services and care received by complicated cases. Therefore, the ImTeCHO application was developed to integrate mHealth strategies in the form of job aid to ASHAs to assist with scheduling, behavior change communication, diagnosis, and patient management, along with supervision and support of ASHAs. During the pilot, the intervention and its delivery were found to be largely acceptable, feasible, and useful. A few changes were made to the intervention and its delivery, including 1) a new helpline for ASHAs, 2) further simplification of processes within the ImTeCHO incentive management system and 3) additional web-based features for enhancing value and supervision of Primary Health Center (PHC) staff.
Conclusions: The effectiveness of the improved ImTeCHO intervention will be now tested through a cluster randomized trial.