Skip to main content
Top
Published in: BMC Pregnancy and Childbirth 1/2018

Open Access 01-12-2018 | Study protocol

What makes the pregnant women revisit public hospitals for research? Participant engagement and retention trial in a public hospital (PERTH): an RCT protocol

Authors: Giridhara R Babu, Maithili Karthik, Deepa Ravi, Yamuna Ana, Prafulla Shriyan, Kiran Kumar Hasige, Keerti Deshpande, Lokesh Bangalore Siddlingaiah, Sanjay Kinra, Gudlavalleti Venkata Satyanarayana Murthy

Published in: BMC Pregnancy and Childbirth | Issue 1/2018

Login to get access

Abstract

Background

Cohort studies have public health importance as they effectively provide evidence on determinants of health from a life course perspective. Researchers often confront the poor follow-up rates as a major challenge in the successful conduct of cohort studies. We are currently recruiting in a birth cohort study, titled as “Maternal Antecedents of Adiposity and Studying the Transgenerational role of Hyperglycemia and Insulin” (MAASTHI) in a public hospital; with the aim of assessing maternal glycemic levels on the risk of adverse fetal outcomes. Nested within the ongoing cohort, the proposed trial aims to evaluate the effectiveness of two interventions in improving the follow-up in the cohort study in a public hospital.

Methods

A randomized trial of 795 pregnant women, with 265 women each in three arms observed through pregnancy, until their baby is 14 weeks old. The comparator group receives a standard leaflet, with details on the importance of glucose testing and regular follow up in pregnancy. Intervention arm-1 will receive the standard leaflet plus individualized messages, through an Interactive Voice Response (IVR) system; a type of computer-linked telephone intervention system to remind the participants about the lab test and follow-up dates. Intervention arm- 2 will have the opportunity to attend Mother and Baby Affairs (MBA) workshops, which will provide information on Gestational Diabetes Mellitus (GDM) screening and management to pregnant women and personalized counselling services. The outcome of interest is the difference in the proportion of participants completing follow-up at different points in time, among three arms.

Discussion

Between the two interventions (IVR and MBA), the study results would uncover the contextually specific, timely intervention, which can increase the proportion of pregnant women followed up in public hospitals. If effective, this study will provide information on an effective intervention, useful in ensuring the success of longitudinal follow-up in the public hospitals.

Trial registration

NCT03088501, Date Registered: 16/03/2017.
Literature
1.
go back to reference Antonisamy B, Raghupathy P, Christopher S, Richard J, Rao P, Barker DJ, Fall CH. Cohort profile: the 1969–73 Vellore birth cohort study in South India. Int J Epidemiol. 2008;38(3):663–9.CrossRefPubMedPubMedCentral Antonisamy B, Raghupathy P, Christopher S, Richard J, Rao P, Barker DJ, Fall CH. Cohort profile: the 1969–73 Vellore birth cohort study in South India. Int J Epidemiol. 2008;38(3):663–9.CrossRefPubMedPubMedCentral
2.
go back to reference Huffman MD, Prabhakaran D, Osmond C, Fall CH, Tandon N, Lakshmy R, Ramji S, Khalil A, Gera T, Prabhakaran P. Incidence of cardiovascular risk factors in an Indian urban cohort. J Am Coll Cardiol. 2011;57(17):1765–74.CrossRefPubMedPubMedCentral Huffman MD, Prabhakaran D, Osmond C, Fall CH, Tandon N, Lakshmy R, Ramji S, Khalil A, Gera T, Prabhakaran P. Incidence of cardiovascular risk factors in an Indian urban cohort. J Am Coll Cardiol. 2011;57(17):1765–74.CrossRefPubMedPubMedCentral
3.
go back to reference Patel MX, Doku V, Tennakoon L. Challenges in recruitment of research participants. Adv Psychiatr Treat. 2003;9(3):229–38.CrossRef Patel MX, Doku V, Tennakoon L. Challenges in recruitment of research participants. Adv Psychiatr Treat. 2003;9(3):229–38.CrossRef
4.
go back to reference Rothman KJ, Greenland S, Lash TL. Modern epidemiology. Philadelphia: Lippincott Williams & Wilkins; 2008. Rothman KJ, Greenland S, Lash TL. Modern epidemiology. Philadelphia: Lippincott Williams & Wilkins; 2008.
6.
go back to reference Bhide P, Gund P, Kar A. Prevalence of congenital anomalies in an Indian maternal cohort: healthcare, prevention, and surveillance implications. PLoS One. 2016;11(11):e0166408.CrossRefPubMedPubMedCentral Bhide P, Gund P, Kar A. Prevalence of congenital anomalies in an Indian maternal cohort: healthcare, prevention, and surveillance implications. PLoS One. 2016;11(11):e0166408.CrossRefPubMedPubMedCentral
7.
go back to reference Laishram J, Mukhia S, Thounaojam UD, Devi HS, Panmei J: Knowledge and practice of ante-natal care in an urban area. 2013. Laishram J, Mukhia S, Thounaojam UD, Devi HS, Panmei J: Knowledge and practice of ante-natal care in an urban area. 2013.
8.
go back to reference Vidler M, Ramadurg U, Charantimath U, Katageri G, Karadiguddi C, Sawchuck D, Qureshi R, Dharamsi S, Joshi A, von Dadelszen P, et al. Utilization of maternal health care services and their determinants in Karnataka State, India. Reprod Health. 2016;13(1):37.CrossRefPubMedPubMedCentral Vidler M, Ramadurg U, Charantimath U, Katageri G, Karadiguddi C, Sawchuck D, Qureshi R, Dharamsi S, Joshi A, von Dadelszen P, et al. Utilization of maternal health care services and their determinants in Karnataka State, India. Reprod Health. 2016;13(1):37.CrossRefPubMedPubMedCentral
9.
go back to reference Sciences IIfP. National family health survey, India-4. In: Ministry of health and family welfare; 2015–16. Sciences IIfP. National family health survey, India-4. In: Ministry of health and family welfare; 2015–16.
10.
go back to reference Pai N, Supe P, Kore S, Nandanwar Y, Hegde A, Cutrell E, Thies W. Using automated voice calls to improve adherence to iron supplements during pregnancy: a pilot study. In: Proceedings of the sixth international conference on information and communication technologies and development: full papers-volume 1: 2013. New York: ACM; 2013. p. 153–63. Pai N, Supe P, Kore S, Nandanwar Y, Hegde A, Cutrell E, Thies W. Using automated voice calls to improve adherence to iron supplements during pregnancy: a pilot study. In: Proceedings of the sixth international conference on information and communication technologies and development: full papers-volume 1: 2013. New York: ACM; 2013. p. 153–63.
11.
go back to reference Erich Weiss JEL, St. John Fisher. Randomized controlled trials of interactive voice response (IVR) systems to improve health outcomes: a review of the literature. 2014. Erich Weiss JEL, St. John Fisher. Randomized controlled trials of interactive voice response (IVR) systems to improve health outcomes: a review of the literature. 2014.
12.
go back to reference Joseph J, Suggu K, Hariharan N, Esiru G, Yavuz E, Gross J, Mirembe B. Increasing retention of HIV-positive pregnant and postnatal women and HIV-exposed infants: measuring the effects of follow-up activities and improved patient management in rural Uganda. In: Journal of the International Aids Society. Geneva: Int Aids Society Avenue De France 23; 2016. Joseph J, Suggu K, Hariharan N, Esiru G, Yavuz E, Gross J, Mirembe B. Increasing retention of HIV-positive pregnant and postnatal women and HIV-exposed infants: measuring the effects of follow-up activities and improved patient management in rural Uganda. In: Journal of the International Aids Society. Geneva: Int Aids Society Avenue De France 23; 2016.
13.
go back to reference Smith C, Gold J, Ngo TD, Sumpter C, Free C. Mobile phone-based interventions for improving contraception use: The Cochrane Library. New Jersey: Wiley; 2015. Smith C, Gold J, Ngo TD, Sumpter C, Free C. Mobile phone-based interventions for improving contraception use: The Cochrane Library. New Jersey: Wiley; 2015.
14.
go back to reference Reidel K, Tamblyn R, Patel V, Huang A. Pilot study of an interactive voice response system to improve medication refill compliance. BMC Med Inform Decis Mak. 2008;8(1):46.CrossRefPubMedPubMedCentral Reidel K, Tamblyn R, Patel V, Huang A. Pilot study of an interactive voice response system to improve medication refill compliance. BMC Med Inform Decis Mak. 2008;8(1):46.CrossRefPubMedPubMedCentral
15.
go back to reference Andersson C, Danielsson S, Silfverberg-Dymling G, Löndahl G, Johansson BA. Evaluation of interactive voice response (IVR) and postal survey in the follow-up of children and adolescents discharged from psychiatric outpatient treatment: a randomized controlled trial. Springerplus. 2014;3(1):77.CrossRefPubMedPubMedCentral Andersson C, Danielsson S, Silfverberg-Dymling G, Löndahl G, Johansson BA. Evaluation of interactive voice response (IVR) and postal survey in the follow-up of children and adolescents discharged from psychiatric outpatient treatment: a randomized controlled trial. Springerplus. 2014;3(1):77.CrossRefPubMedPubMedCentral
16.
go back to reference Khurana M. Case studies on E Governance in India. In: division NE-G, editor. AAROGYAM: an ICT-based community-centric approach for improving Reproductive and Child Health; 2013–14. Khurana M. Case studies on E Governance in India. In: division NE-G, editor. AAROGYAM: an ICT-based community-centric approach for improving Reproductive and Child Health; 2013–14.
17.
go back to reference Lunze K, Higgins-Steele A, Simen-Kapeu A, Vesel L, Kim J, Dickson K. Innovative approaches for improving maternal and newborn health-a landscape analysis. BMC Pregnancy Childbirth. 2015;15(1):337.CrossRefPubMedPubMedCentral Lunze K, Higgins-Steele A, Simen-Kapeu A, Vesel L, Kim J, Dickson K. Innovative approaches for improving maternal and newborn health-a landscape analysis. BMC Pregnancy Childbirth. 2015;15(1):337.CrossRefPubMedPubMedCentral
18.
go back to reference Babu GR, Murthy G, Deepa R, Kumar HK, Karthik M, Deshpande K, Neelon SEB, Prabhakaran D, Kurpad A, Kinra S. Maternal antecedents of adiposity and studying the transgenerational role of hyperglycemia and insulin (MAASTHI): a prospective cohort study. BMC Pregnancy Childbirth. 2016;16(1):311.CrossRefPubMedPubMedCentral Babu GR, Murthy G, Deepa R, Kumar HK, Karthik M, Deshpande K, Neelon SEB, Prabhakaran D, Kurpad A, Kinra S. Maternal antecedents of adiposity and studying the transgenerational role of hyperglycemia and insulin (MAASTHI): a prospective cohort study. BMC Pregnancy Childbirth. 2016;16(1):311.CrossRefPubMedPubMedCentral
19.
go back to reference Eldredge LKB, Parcel GS, Kok G, Gottlieb NH. Planning health promotion programs: an intervention mapping approach. New Jersey: Wiley; 2011. Eldredge LKB, Parcel GS, Kok G, Gottlieb NH. Planning health promotion programs: an intervention mapping approach. New Jersey: Wiley; 2011.
20.
go back to reference Ryan RM, Kuhl J, Deci EL. Nature and autonomy: an organizational view of social and neurobiological aspects of self-regulation in behavior and development. Dev Psychopathol. 1997;9(4):701–28.CrossRefPubMed Ryan RM, Kuhl J, Deci EL. Nature and autonomy: an organizational view of social and neurobiological aspects of self-regulation in behavior and development. Dev Psychopathol. 1997;9(4):701–28.CrossRefPubMed
21.
go back to reference Gollwitzer PM, Sheeran P. Implementation intentions and goal achievement: a meta-analysis of effects and processes. Adv Exp Soc Psychol. 2006;38:69–119.CrossRef Gollwitzer PM, Sheeran P. Implementation intentions and goal achievement: a meta-analysis of effects and processes. Adv Exp Soc Psychol. 2006;38:69–119.CrossRef
22.
go back to reference Crawford AG, Sikirica V, Goldfarb N, Popiel RG, Patel M, Wang C, Chu JB, Nash DB. Interactive voice response reminder effects on preventive service utilization. Am J Med Qual. 2005;20(6):329–36.CrossRefPubMed Crawford AG, Sikirica V, Goldfarb N, Popiel RG, Patel M, Wang C, Chu JB, Nash DB. Interactive voice response reminder effects on preventive service utilization. Am J Med Qual. 2005;20(6):329–36.CrossRefPubMed
23.
go back to reference Kim H, Bracha Y, Tipnis A. Automated depression screening in disadvantaged pregnant women in an urban obstetric clinic. Arch Womens Ment Health. 2007;10(4):163–9.CrossRefPubMed Kim H, Bracha Y, Tipnis A. Automated depression screening in disadvantaged pregnant women in an urban obstetric clinic. Arch Womens Ment Health. 2007;10(4):163–9.CrossRefPubMed
24.
go back to reference Steinberg DM, Levine EL, Lane I, Askew S, Foley PB, Puleo E, Bennett GG. Adherence to self-monitoring via interactive voice response technology in an eHealth intervention targeting weight gain prevention among black women: randomized controlled trial. J Med Internet Res. 2014;16(4):e114.CrossRefPubMedPubMedCentral Steinberg DM, Levine EL, Lane I, Askew S, Foley PB, Puleo E, Bennett GG. Adherence to self-monitoring via interactive voice response technology in an eHealth intervention targeting weight gain prevention among black women: randomized controlled trial. J Med Internet Res. 2014;16(4):e114.CrossRefPubMedPubMedCentral
25.
go back to reference Shaw WS, Verma SK. Data equivalency of an interactive voice response system for home assessment of back pain and function. Pain Res Manag. 2007;12(1):23.CrossRefPubMedPubMedCentral Shaw WS, Verma SK. Data equivalency of an interactive voice response system for home assessment of back pain and function. Pain Res Manag. 2007;12(1):23.CrossRefPubMedPubMedCentral
26.
go back to reference Pollak KI, Alexander SC, Bennett G, Lyna P, Coffman CJ, Bilheimer A, Farrell D, Bodner ME, Swamy GK, Østbye T. Weight-related SMS texts promoting appropriate pregnancy weight gain: a pilot study. Patient Educ Couns. 2014;97(2):256–60.CrossRefPubMedPubMedCentral Pollak KI, Alexander SC, Bennett G, Lyna P, Coffman CJ, Bilheimer A, Farrell D, Bodner ME, Swamy GK, Østbye T. Weight-related SMS texts promoting appropriate pregnancy weight gain: a pilot study. Patient Educ Couns. 2014;97(2):256–60.CrossRefPubMedPubMedCentral
27.
28.
go back to reference Kelsey JL. Methods in observational epidemiology, vol. 26. USA: Oxford University Press; 1996. Kelsey JL. Methods in observational epidemiology, vol. 26. USA: Oxford University Press; 1996.
29.
go back to reference Johnson JE, Fieler VK, Wlasowicz GS, Mitchell ML, Jones LS. The effects of nursing care guided by self-regulation theory on coping with radiation therapy. In: Oncology nursing forum: 1997; 1997. p. 1041–50. Johnson JE, Fieler VK, Wlasowicz GS, Mitchell ML, Jones LS. The effects of nursing care guided by self-regulation theory on coping with radiation therapy. In: Oncology nursing forum: 1997; 1997. p. 1041–50.
30.
go back to reference Kranzler HR, A-H K, Tennen H, Feinn R, Young K. Using daily interactive voice response technology to measure drinking and related behaviors in a pharmacotherapy study. Alcohol Clin Exp Res. 2004;28(7):1060–4.CrossRefPubMed Kranzler HR, A-H K, Tennen H, Feinn R, Young K. Using daily interactive voice response technology to measure drinking and related behaviors in a pharmacotherapy study. Alcohol Clin Exp Res. 2004;28(7):1060–4.CrossRefPubMed
31.
go back to reference Alemi F, Stephens R, Parran T, Llorens S, Bhatt P, Ghadiri A, Eisenstein E. Automated monitoring of outcomes: application to treatment of drug abuse. Med Decis Mak. 1994;14(2):180–7.CrossRef Alemi F, Stephens R, Parran T, Llorens S, Bhatt P, Ghadiri A, Eisenstein E. Automated monitoring of outcomes: application to treatment of drug abuse. Med Decis Mak. 1994;14(2):180–7.CrossRef
33.
go back to reference Campbell MK, Carbone E, Honess-Morreale L, Heisler-MacKinnon J, Demissie S, Farrell D. Randomized trial of a tailored nutrition education CD-ROM program for women receiving food assistance. J Nutr Educ Behav. 2004;36(2):58–66.CrossRefPubMed Campbell MK, Carbone E, Honess-Morreale L, Heisler-MacKinnon J, Demissie S, Farrell D. Randomized trial of a tailored nutrition education CD-ROM program for women receiving food assistance. J Nutr Educ Behav. 2004;36(2):58–66.CrossRefPubMed
34.
go back to reference Svensson J, Barclay L, Cooke M. Randomised-controlled trial of two antenatal education programmes. Midwifery. 2009;25(2):114–25.CrossRefPubMed Svensson J, Barclay L, Cooke M. Randomised-controlled trial of two antenatal education programmes. Midwifery. 2009;25(2):114–25.CrossRefPubMed
35.
go back to reference Rolls C, Cutts D. Pregnancy-to-parenting education: creating a new approach. Birth Issues. 2001;10(2):53–8. Rolls C, Cutts D. Pregnancy-to-parenting education: creating a new approach. Birth Issues. 2001;10(2):53–8.
36.
go back to reference Lee H, Friedman ME, Cukor P, Ahern D. Interactive voice response system (IVRS) in health care services. Nurs Outlook. 2003;51(6):277–83. Lee H, Friedman ME, Cukor P, Ahern D. Interactive voice response system (IVRS) in health care services. Nurs Outlook. 2003;51(6):277–83.
37.
go back to reference Hyman DJ, Ho KSI, Dunn JK, Simons-Morton D. Dietary intervention for cholesterol reduction in public clinic patients. Am J Prev Med. 1998;15(2):139–45. Hyman DJ, Ho KSI, Dunn JK, Simons-Morton D. Dietary intervention for cholesterol reduction in public clinic patients. Am J Prev Med. 1998;15(2):139–45.
38.
go back to reference Barta WD, Portnoy DB, Kiene SM, Tennen H, Abu-Hasaballah KS, Ferrer R. A Daily Process Investigation of Alcohol-involved Sexual Risk Behavior Among Economically Disadvantaged Problem Drinkers Living with HIV/AIDS. AIDS Behav. 2008;12(5):729–40. https://doi.org/10.1007/s10461-007-9342-4. Barta WD, Portnoy DB, Kiene SM, Tennen H, Abu-Hasaballah KS, Ferrer R. A Daily Process Investigation of Alcohol-involved Sexual Risk Behavior Among Economically Disadvantaged Problem Drinkers Living with HIV/AIDS. AIDS Behav. 2008;12(5):729–40. https://​doi.​org/​10.​1007/​s10461-007-9342-4.
Metadata
Title
What makes the pregnant women revisit public hospitals for research? Participant engagement and retention trial in a public hospital (PERTH): an RCT protocol
Authors
Giridhara R Babu
Maithili Karthik
Deepa Ravi
Yamuna Ana
Prafulla Shriyan
Kiran Kumar Hasige
Keerti Deshpande
Lokesh Bangalore Siddlingaiah
Sanjay Kinra
Gudlavalleti Venkata Satyanarayana Murthy
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2018
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-018-2000-1

Other articles of this Issue 1/2018

BMC Pregnancy and Childbirth 1/2018 Go to the issue