Assessing the Impact of Mobile Phone Technology to Improve Health Nutrition and Population (HNP) Service Utilization in Rural Bangladesh Through Pilot Intervention
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|ClinicalTrials.gov Identifier: NCT03189004|
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : December 11, 2018
|First Submitted Date ICMJE||May 21, 2017|
|First Posted Date ICMJE||June 16, 2017|
|Last Update Posted Date||December 11, 2018|
|Actual Study Start Date ICMJE||April 2016|
|Estimated Primary Completion Date||September 2019 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT03189004 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Assessing the Impact of Mobile Phone Technology to Improve Health Nutrition and Population (HNP) Service Utilization in Rural Bangladesh Through Pilot Intervention|
|Official Title ICMJE||Assessing the Impact of Mobile Phone Technology to Improve Health Nutrition and Population (HNP) Service Utilization in Rural Bangladesh Through Pilot Intervention|
At present in Bangladesh, the CCs cater the services on family planning, maternal neonatal and child health (MNCH), health education for the rural people by using e-health strategy as the community health care provider (CHCP), newly recruited staff of community clinic are equipped with internet connected laptop service. So, updated technology for updating information, follow up and referral in primary health care can be used to increase the utilization of health services.
Hypothesis (if any):
Use of smart phones by community level healthcare providers will increase utilization of reproductive health (RH) and family planning (FP), MNCH, integrated management of childhood illness (IMCI), EPI and other PHC services at rural communities in Bangladesh.
To develop and test a mechanism as well as assess the impact of mHealth strategy to improve RH and FP, MNCH, IMCI, EPI and other PHC services in rural communities of Bangladesh.
The service delivery personnel who are providing the services to the community people at different levels (community clinic, union health and family welfare centre, upazila health complex) will be equipped with smart phones having the facilities for text messages, voice messages as well as internet and data capturing. Training on handling of the smart phones, data capturing and monitoring will be provided to service providers in each upazila. They will be trained to input, edit, verify and monitor the data on different services through the software installed in their smart phones. The community clinic management and support groups will be oriented and motivated on mobile phone based registration, notification and referral to the health facilities.
This will be a quasi-experimental pre-post design study and evaluation will be done through comparing antenatal care (ANC), postnatal care (PNC), and contraceptive prevalence rate (CPR) and EPI coverage before and after its implementation in the study versus comparison areas. The study will be conducted over a period of 30 months.
Introduction In Bangladesh, about 2 million new faces are added to the population annually with a growth rate of 1.4% . Last Health Population and Nutrition Sector Development Programme (HPNSDP) of the Ministry of Health and Family Welfare (MOHFW) had set a target of total fertility rate (TFR) of 2.0 and contraceptive prevalence rate (CPR) of 72 by 2016 which is currently 2.3 and 61.2 respectively. It is necessary to increase the age at first birth as data indicates almost half of women giving birth by age 18 and nearly 70% giving birth by age 20. It is indicated that only 26% women received four or more antenatal care (ANC) visits during their pregnancies, while 68% received at least one ANC during their pregnancies which are the great challenges for ensuring safe motherhood in the country. As a part of safe motherhood, it is estimated that only 29% deliveries are being conducted in health facilities in the country. In case of postnatal care (PNC), from 2008 to 2010, only 27 percent of women received PNC for their last birth from a medically-trained provider within two days of their delivery . Despite the tremendous success of EPI in Bangladesh, a substantial number of children are not fully vaccinated under EPI as data shows 82% were fully vaccinated by the age of 12 months. In case of diarrhoea among under 5 years of age, 25% received treatment from a health facility or healthcare providers. Thirty-five percent of the children under 5 years who had acute respiratory infection (ARI) received treatment from a health facility or healthcare providers. More than six of every ten children with fever sought treatment from the private medical sector. Although 90% of children are breastfeed until age 2, as recommended, but 36 percent of children less than age 6 months are out of exclusively breastfed. Though the health indictors in Bangladesh are improving, these rates are behind from the target.
In recent years, mobile phone use in healthcare (mHealth) has emerged to augmented of healthcare services where the population is underserved especially in rural areas . In a systematic review, Tamrat and colleagues (2011) highlighted the scope of mHealth along the stages of the 'continuum of care' for maternal, newborn and child healthcare . mHealth programs are being used for pregnancy tracking, appointment reminders for antenatal care, and SMS-based health education during pregnancy. During the birth, mHealth can be used for point-of-care remote consultation, facilitate referral to health facility; facilitate access to health facility and to promote timely contact with community health workers. For postpartum and newborn care, mHealth can be used for maternal and infant growth monitoring, timely reminders for immunization .
In Bangladesh, mHealth and eHealth initiatives are being implemented by MOHFW and different organizations and donors are supporting to the initiatives. This initiative will complement with existing health systems and contribute to increase effectiveness of HPN services by using mobile phone based technologies.
The Government of Bangladesh has placed a high priority on eHealth, which is reflected in the ICT Policy 2009. The strategic areas/issues relevant to health in the ICT Policy 2009 include the following (Clauses 7.1-7.4 of ICT Policy): 'Improve healthcare delivery management through use of telemedicine and modern technology; create awareness at all levels, including hard-to-reach areas with particular importance in making maternal, child and reproductive care available; ensure quality of care and increase the capacity of health care delivery system'. But use of technology for covering all or major components of primary health care (PHC) is yet to be developed and tested in Bangladesh. Further, no such initiative has yet been taken focusing community clinic (CC) to ensure universal health coverage in Bangladesh.
At present, in Bangladesh, the CCs can cater the services on family planning (FP), maternal neonatal and child health (MNCH) and health education for the rural people by using eHealth strategy as the community health care provider (CHCP) and other staff of CCs are equipped with internet connected laptop service . One recent study findings show that 33% rural married women and 69% of their family members have mobile phones. Therefore, the MOHFW, icddr,b and Ethics Advance Technology Limited (EATL) have taken this initiative to utilize mobile phone technology to improve HPN service in rural areas of Bangladesh. This study will be implemented with the aim to develop and test a mechanism of mHealth strategies as well as assessing the impact in improving reproductive health and family planning, maternal neonatal and child health, integrated management of childhood illness, expanded programme on immunization, and other primary health care services in community level in rural areas of Bangladesh. This is an evidence based research for HPN services using mobile technology and proposed extension of the project and integrated with health system of the Government in Bangladesh.
This study aims to: 1) Improve coverage of ANC, delivery care and PNC; 2) Improve use of family planning services among newly married couples to increase the age at first birth; 3) Improve utilization of MNCH services including EPI services to reduce neonatal mortality rate; 4) Assess acceptability of providing health education regarding family planning, nutrition, breastfeeding; 5) Establish technology based referral linkage of CCs with the higher facilities.
Methods Study design
The study will follow a quasi-experimental pre-post design. Evaluation will be carried-out through comparing ANC, delivery care, PNC, contraceptive prevalence rate (CPR) and EPI coverage before and after its implementation between the study and the comparison areas.
The study will be conducted in two selected administrative divisions of Bangladesh: one high performing (Rajshahi) division and one low performing (Chittagong) division. Based on the performance of health and family planning indicators, the selected districts are: Natore from the high performing (Rajshahi) division and Cox's Bazar from the low performing (Chittagong) division. In high performing division, one upazila (Bagatipara) of Natore district will be the intervention upazila while Baraigram of the same district will be the comparison upazila. On the other hand, one upazila (Chakaria) of Cox's Bazar district will be the intervention upazila while Ramu will be the comparison upazila. A total of 4 upazilas (2 intervention and 2 comparision upazilas) from the two divisions will be selected for the study.
Timeline The study will be conducted over a period of 30 months in three phases: (i) inception phase (6 months for IRB approval, recruitment of staff, stakeholders' meetings at different levels, mobile apps and survey instrument development, training of GoB staff on interventions, baseline survey and inception report preparation); (ii) intervention implementation phase (18 months for implementation of intervention; (iii) evaluation phase (4 months for end line data collection, data analysis and report writing, sharing of the results and evidence for future scaling up through dissemination, finalization of report and publications).
Mobile apps development and testing
The mobile apps were developed by a team a team from Ethics Advanced Technology Limited (EATL). After developing the apps study team did the filed test and piloting in other than project areas. After receiving the feedback, study team tried to make the easiest apps. The SMS messages were developed by a team comprising of general physicians, immunization expert, family planning expert, health systems expert, health care provider, GoB officials and non government officials. After developing the SMS messages in Bengali, study team sent these messages to several individuals in the pre-test stage including persons who can only read SMS and have no formal education qualifications. After receiving the feedback, study team tried to make the contents of the SMS suitable for the general population. Investigators will ensure that all our participants in the study can read the SMS messages by themselves or someone in the family who can describe the messages to them if they do not understand.
The Bangladesh government provides primary health care services to all citizens through a three-tiered healthcare service delivery system: the community clinics, each for 8000 people; the union health and family welfare centres (UH&FWCs), each for 25,000 people; and the upazila (sub-district) health complexes (UHCs) with an out-patient and an emergency departments, 50 in-patient beds and an operating room, each for 250,000 people, which coordinate services between different tiers. The service delivery personnel at different levels (CC, UH&FWC, UHC) will be equipped with Smartphones having the facilities for text messages, voice messages as well as internet and data capturing. Smartphones will be provided to them from the project. Training on handling of the Smartphones, data capturing and monitoring will be provided to upazila Health and family planning officer (UHFPO), upazila family planning officer (UFPO), medical officers (health and family planning departments), the statistical assistant, family welfare visitors (FWVs), sub-assistant community medical officers (SACMOs), nurses and medical technologist, health inspectors (HIs), family planning inspectors (FPIs), assistant health inspectors (AHIs), health assistants (HAs), family welfare assistances (FWAs), community health care providers (CHCPs) and other related service providers in each upazila. They will be trained to input, edit, verify and monitor the data on different services through the software installed in their Smartphones. The community clinic management and support groups will be oriented and motivated on mobile phone based registration, notification and referral to the health facilities. A team from Ethics Advanced Technology Limited (EATL), a software development company will provide technical support to develop the device, train concerned personnel, and continue support in smooth functioning of the system. The interventions to be tested are as below:
There will be web based monitoring system to oversee the progress and status of all the activities under this study for policy makers, programme peoples and other supervisors from national to the union levels. All these data will be available in the central database which will be visualized and accessible at all concerned levels through internet in particular website. They can constantly follow up the progression and healthcare delivery system of the respective area and provide regular feedback, when necessary. There will be provision of auto-generation of reports for each and every activity through the system by area and service provider specific. Figure-2 shows the interventions implementation process and Figure-3 shows the snap shots of apps developed.
Study population The study populations will be: (i) currently married women of reproductive age not currently pregnant and did not have delivery within last 6 months; (ii). Mothers of children aged 12-23 months for assessing children's vaccination coverage; (iii). Mothers of children aged 0-11 months for assessing ANC, delivery care, PNC and vaccination coverage; and iv. The healthcare service providers.
Procedures for selection of sample clusters: In the catchment area of a CC there are 8 routine EPI centers (including the CCs one) each serving, on an average, ~1000 people (or ~235 households). The catchment area of the EPI centre will be treated as 'cluster'. Given the crude birth rate of ~20 per 1000 population per year there will be 20 mothers who have a infant aged 0-11 months eligible to provide information on ANC, delivery care and PNC; and another 20 mothers who have a toddler aged 12-23 months eligible to provide information on child vaccination. As such, 33 EPI centers from the list of EPI centers of an upazila (with at least one EPI centre per CC) in the selected sub-district will be randomly chosen for survey.
Selection of households: The second stage will be selection of households with eligible respondents in each sampled cluster (or EPI centre catchment area). With their consent all mothers with child aged 0-11 months or 12-23 months will be interviewed for maternity care and vaccination respectively. Women (married non-pregnant or did not delivered baby in <6 months) eligible for family planning use are many in a cluster. Therefore, a woman eligible for family planning method use living in the household next to the mother with a child aged 0-11 months will be interviewed. The same sample selection procedures will be followed in the comparision areas.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
|Intervention ICMJE||Behavioral: Impact of Mobile Phone Technology to Improve Health Nutrition and Population (HNP) Service Utilization in Rural Bangladesh
Other Name: Assessing the Impact of Mobile Phone Technology to Improve Health Nutrition and Population (HNP) Service Utilization in Rural Bangladesh through Pilot Intervention
|Study Arms ICMJE||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||September 2019|
|Estimated Primary Completion Date||September 2019 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||18 Years to 45 Years (Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Listed Location Countries ICMJE||Bangladesh|
|Removed Location Countries|
|NCT Number ICMJE||NCT03189004|
|Other Study ID Numbers ICMJE||16019|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||International Centre for Diarrhoeal Disease Research, Bangladesh|
|Study Sponsor ICMJE||International Centre for Diarrhoeal Disease Research, Bangladesh|
|Collaborators ICMJE||Not Provided|
|PRS Account||International Centre for Diarrhoeal Disease Research, Bangladesh|
|Verification Date||August 2018|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP