Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431581
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-14
Brief Title:
Effect of a Mobile Health Intervention on Birth Outcome and Infant Health
Sponsor:
Kathmandu University School of Medical Sciences
Organization:
Kathmandu University School of Medical Sciences
Study Overview
Official Title:
Effect of a Mobile Health Intervention on Birth Outcome and Infant Health in a Tertiary Healthcare Facility in Nepal
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Globally neonatal and infant mortality persist as challenging concerns paralleled by a notable prevalence of low birth weight preterm birth and challenges in child growth and development Some of the factors contributing to these issues include poor maternal health and nutrition maternal smoking and insufficient maternal awareness Despite global efforts to improve maternal newborn and child health adverse birth outcomes remain significant challenges particularly in low and middle-income countries LMICs A noteworthy observation is that not all pregnant women modify their behaviors for their and their babys health due to lack of social support fear and insecurity Recognizing the potential for interventions during pregnancy to positively influence maternal fetal and neonatal health this research underscores the role of Mobile Health mHealth technologies in leveraging information and communication technology for health service delivery
Accordingly the study aims to evaluate the effect of mobile health intervention on birth outcomes and infant health in Nepal In the initial phase a qualitative study will be conducted to explore the enablers and barriers of perinatal care and preferences of pregnant women through focus group discussions These insights will inform the development of user-centered educational videos and tailored m-Health interventions for pregnant women
A two-arm parallel randomized controlled trial will then assess the m-Health interventions effect on the birth outcomes and infant health of the pregnant women attending the antenatal care clinic of Dhulikhel Hospital The investigaotors will randomize pregnant women at gestational age 14-22 weeks into either a control group who will receive standard care along with a control video and reminder phone call for follow-up or an intervention group who will receive standard care along with m-health intervention that includes educational video short message service SMS and reminder phone call for follow up
Follow-up will be done from enrollment until the child reaches one year of age with a focus on evaluating effect of m-Health intervention on birth outcomes birth weight and gestational age at delivery and infant health growth and development of the infant Data collection will utilize a self-constructed semi-structured questionnaire along with validated questionnaires The collected data will be analyzed using STATA 14 contributing valuable insights into the potential effect of m-Health intervention on birth outcomes and infant health
Accordingly the study aims to evaluate the effect of mobile health intervention on birth outcomes and infant health in Nepal In the initial phase a qualitative study will be conducted to explore the enablers and barriers of perinatal care and preferences of pregnant women through focus group discussions These insights will inform the development of user-centered educational videos and tailored m-Health interventions for pregnant women
A two-arm parallel randomized controlled trial will then assess the m-Health interventions effect on the birth outcomes and infant health of the pregnant women attending the antenatal care clinic of Dhulikhel Hospital The investigaotors will randomize pregnant women at gestational age 14-22 weeks into either a control group who will receive standard care along with a control video and reminder phone call for follow-up or an intervention group who will receive standard care along with m-health intervention that includes educational video short message service SMS and reminder phone call for follow up
Follow-up will be done from enrollment until the child reaches one year of age with a focus on evaluating effect of m-Health intervention on birth outcomes birth weight and gestational age at delivery and infant health growth and development of the infant Data collection will utilize a self-constructed semi-structured questionnaire along with validated questionnaires The collected data will be analyzed using STATA 14 contributing valuable insights into the potential effect of m-Health intervention on birth outcomes and infant health
Detailed Description:
To evaluate the effect of mobile health intervention on birth outcome and infant health the sequential exploratory research design will be used In the initial phase a qualitative study will be conducted The researcher and the research assistant will employ purposive sampling to select pregnant women visiting Dhulikhel Hospital in the out patient department OPD of the Obstetric department Written informed consent will be obtained from research participants by either the researcher or research assistant A focus group discussion will be conducted with pregnant women regarding enablers barriers and preferences in perinatal care for improving birth outcomes and infant health A topic guide will be used for data collection Subsequently another focus group discussion will be done with the same participants after developing the educational video to assess the satisfaction and acceptability of the video within the targeted group The goal of these focus group discussions are to understand the users needs in educational video The investigators will ensure that the educational video is user-centered by involving end users pregnant women throughout the design and development process Then after the content of educational video will be subjected to content validity assessments by subject matter experts to ascertain its accuracy and suitability
After development and finalization of tailored educational video a randomized controlled trial will be conducted Prior to data collection the researcher will provide information regarding the study such as purpose of the study and assistance required to the health professionals of the antenatal OPD
Phase 1 Recruitment baseline data collection and randomization
The head of the obstetrics and pediatric departments as well as healthcare professionals at the antenatal care ANC clinic and immunization clinic will be informed about the study Their active cooperation will be sought throughout the study duration Pregnant women who are of 14 to 22 weeks of gestation and meet the specified inclusion criteria while attending the antenatal clinic at Dhulikhel Hospital will be provided with comprehensive information about the study This information will cover the studys rationale procedures follow-up schedules and voluntary nature of their participation Eligibility assessments for pregnant women will be conducted by the researcher Those who expresses a willingness to participate will be asked to provide written informed consent To ensure impartial allocation of participants to either the intervention or control group a random sequence number will be generated by a statistician using a computer These numbers will be securely sealed in envelopes and provided to the enrolled pregnant women Subsequently pregnant women who have agreed to participate will be randomized into either the intervention or control group with a 11 ratio based on the group specified within the sealed envelopes provided to them The researcher or research assistant will collect baseline information and gather data related to the knowledge of perinatal care for a healthy birth and a healthy infant from the participants in both the intervention and control groups
Phase 2 Delivery of the intervention
Development of intervention guide To maintain consistent and standardized delivery of the intervention to all participants an intervention guide SMS guide and telephone guide will be developed
Intervention group Participants in the intervention group will have access to the educational videos and will be exposed to the following sequence of events
During the baseline data collection phase the initial educational video addressing perinatal care for a healthy birth and healthy infant will be viewed by participants via a tablet in a separate designated setting
Subsequently this video will be made available on their smartphones and participants will be instructed to watch it multiple times during their pregnancy
Participants will receive reminder phone calls and SMS to encourage them to watch videos at least three more times after their initial viewing in the antenatal care clinic
To ensure continuous engagement the researcher will maintain regular contact through phone call with intervention group participants reminding them to view the videos every month from the time of enrollment until delivery and till the child reaches 1 year of age as per the reminder schedule
Additionally pregnant mothers will be explicitly instructed to discuss the video content solely with their immediate family members and refrain from sharing it with others
Control group In contrast participants in the control group will receive usual standard care and will be allowed to view a control video Participants will be contacted through phone calls to remind their follow-up visit
Phase 3 Follow up
Participant assessment and follow-up The participants from both the intervention and control groups will undergo a series of assessments and follow -up visits
Post intervention knowledge assessment Following the intervention phase both groups will be subjected to a post-intervention knowledge assessment The overall knowledge of perinatal care for birth outcome and infant health will be assessed approximately one month following the participants initial viewing of the videos
Birth outcome assessment Both the intervention and control group participants will be followed up within the first 24 hours of their delivery to evaluate and record the birth outcomes
Infant health assessment In the subsequent phase of the study which aims to evaluate the impact of the intervention on infant health the growth and development of infant will be assessed Both groups will be informed of the necessity of follow-up visits at the immunization clinic through phone calls Following the notification the growth and developmental assessments of the infants will be conducted at the immunization clinic on the day of their scheduled immunization visit at 6 weeks 14 weeks 9 months and 12 months of life For those participants who are unable to visit immunization clinic of Dhulikhel Hospital they will be followed up at their nearby health post or within their homes This follow-up process will be conducted by the researcher along with the assistance of a research assistant
After development and finalization of tailored educational video a randomized controlled trial will be conducted Prior to data collection the researcher will provide information regarding the study such as purpose of the study and assistance required to the health professionals of the antenatal OPD
Phase 1 Recruitment baseline data collection and randomization
The head of the obstetrics and pediatric departments as well as healthcare professionals at the antenatal care ANC clinic and immunization clinic will be informed about the study Their active cooperation will be sought throughout the study duration Pregnant women who are of 14 to 22 weeks of gestation and meet the specified inclusion criteria while attending the antenatal clinic at Dhulikhel Hospital will be provided with comprehensive information about the study This information will cover the studys rationale procedures follow-up schedules and voluntary nature of their participation Eligibility assessments for pregnant women will be conducted by the researcher Those who expresses a willingness to participate will be asked to provide written informed consent To ensure impartial allocation of participants to either the intervention or control group a random sequence number will be generated by a statistician using a computer These numbers will be securely sealed in envelopes and provided to the enrolled pregnant women Subsequently pregnant women who have agreed to participate will be randomized into either the intervention or control group with a 11 ratio based on the group specified within the sealed envelopes provided to them The researcher or research assistant will collect baseline information and gather data related to the knowledge of perinatal care for a healthy birth and a healthy infant from the participants in both the intervention and control groups
Phase 2 Delivery of the intervention
Development of intervention guide To maintain consistent and standardized delivery of the intervention to all participants an intervention guide SMS guide and telephone guide will be developed
Intervention group Participants in the intervention group will have access to the educational videos and will be exposed to the following sequence of events
During the baseline data collection phase the initial educational video addressing perinatal care for a healthy birth and healthy infant will be viewed by participants via a tablet in a separate designated setting
Subsequently this video will be made available on their smartphones and participants will be instructed to watch it multiple times during their pregnancy
Participants will receive reminder phone calls and SMS to encourage them to watch videos at least three more times after their initial viewing in the antenatal care clinic
To ensure continuous engagement the researcher will maintain regular contact through phone call with intervention group participants reminding them to view the videos every month from the time of enrollment until delivery and till the child reaches 1 year of age as per the reminder schedule
Additionally pregnant mothers will be explicitly instructed to discuss the video content solely with their immediate family members and refrain from sharing it with others
Control group In contrast participants in the control group will receive usual standard care and will be allowed to view a control video Participants will be contacted through phone calls to remind their follow-up visit
Phase 3 Follow up
Participant assessment and follow-up The participants from both the intervention and control groups will undergo a series of assessments and follow -up visits
Post intervention knowledge assessment Following the intervention phase both groups will be subjected to a post-intervention knowledge assessment The overall knowledge of perinatal care for birth outcome and infant health will be assessed approximately one month following the participants initial viewing of the videos
Birth outcome assessment Both the intervention and control group participants will be followed up within the first 24 hours of their delivery to evaluate and record the birth outcomes
Infant health assessment In the subsequent phase of the study which aims to evaluate the impact of the intervention on infant health the growth and development of infant will be assessed Both groups will be informed of the necessity of follow-up visits at the immunization clinic through phone calls Following the notification the growth and developmental assessments of the infants will be conducted at the immunization clinic on the day of their scheduled immunization visit at 6 weeks 14 weeks 9 months and 12 months of life For those participants who are unable to visit immunization clinic of Dhulikhel Hospital they will be followed up at their nearby health post or within their homes This follow-up process will be conducted by the researcher along with the assistance of a research assistant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None