NCP: Mobile Health Intervention to Improve Neonatal Care Practice

• Sponsor: Wollo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05666050
• Collaborator: Jimma University (Other)
• Enrollment: 784
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.6
• Patients Per Site Per Month: 169.2

Study Details

Study Description

Brief Summary

Effectiveness of interactive mobile health intervention (IMHI) to improve neonatal care practice among postpartum women in Dessie and Kombolcha town zones, north east Ethiopia: behavioral cluster randomized control trial.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Care	Behavioral: Mobile health intervention	N/A

Detailed Description

The main aim of this study is to determine effectiveness of mobile health intervention to improve neonatal care practice among postpartum women in Dessie and Kombolcha town zones, North east Ethiopia. First participants will be grouped in to two arms based on randomization of clusters. The intervention arm will take the new intervention with existed health care practice and the control arm will take the existed current health care practice.

The intervention arm will receive sending message service (SMS) over a four month period (90 days pre-natal and 42 days post-partum) and the control arm will receive the existed health care practice. Participants in the intervention arm will receive mobile based health education and health communication messages as well as messages on neonatal care practice based on national maternal and child health care education and counseling guidelines. Participants in this study will be randomly assigned as intervention will receive sending message service from a trained professional; while participants assigned to control group will not receive phone based interventions but can contact their health care providers as routine health facility activity. Initially, study participants will receive one text message every two weeks with the frequency increasing to messages for 42 days following delivery.

Pregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and continued up to 6 weeks of post par-tum period for 4 months. Three intervention worker female nurses/midwifes will be recruited and trained to do the intervention based on the protocol After this end line data will be collected from both intervention and control group.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 784 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Pregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and continued up to 6 weeks of post partum period for 4 months. Three intervention worker female nurses/midwifes will be recruited and trained to do the intervention based on the protocol After this end line data will be collected from both intervention and control group.Pregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and continued up to 6 weeks of post partum period for 4 months. Three intervention worker female nurses/midwifes will be recruited and trained to do the intervention based on the protocol After this end line data will be collected from both intervention and control group.
• Masking: Single (Outcomes Assessor)
• Masking Description: The outcome assessors will be masked about which group is intervention and control to avoid bias.
• Primary Purpose: Health Services Research
• Official Title: Effectiveness of Interactive Mobile Health Intervention (IMHI) to Improve Neonatal Care Practice Among Postpartum Women in Dessie and Kombolcha Town Zones, North East Ethiopia: Behavioral Cluster Randomized Control Trial
• Actual Study Start Date: Dec 5, 2022
• Anticipated Primary Completion Date: Apr 25, 2023
• Anticipated Study Completion Date: Apr 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group The intervention group will receive mobile health intervention sending message service(SMS)	Behavioral: Mobile health intervention; Pregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and will be continued up to 6 weeks of post partum period for 4 months.
No Intervention: Control group The control group will receive the existed current health delivery approach, no mobile health sending message service

Outcome Measures

Primary Outcome Measures

1. Neonatal care practice among the intervention and control group will be measured by The minimum WHO 12 items will be used to produce composite index (score). [Two weeks after intervention the outcome will be measured.]

   Principal component analysis will be done to create composite index (score) and respondents who will have scored above or equal to the mean/median value will be considered as having good neonatal care, while those who will score below the mean/median value were considered as poor neonatal care.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pregnant women 26-28 weeks of gestation and have mobile phone access in the study area.

Exclusion Criteria:

• Pregnant women seriously ill and not able to respond.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dessie and Kombolcha	Dessie	South Wollo	Ethiopia	1145

Sponsors and Collaborators

• Wollo University
• Jimma University

Investigators

• Principal Investigator: Niguss Cherie, Wollo Universirty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Niguss Cherie, Assistant professor, Wollo University
• ClinicalTrials.gov Identifier: NCT05666050
• Other Study ID Numbers: JUIH/IRB/230/22
• First Posted: Dec 27, 2022
• Last Update Posted: Dec 27, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Niguss Cherie, Assistant professor, Wollo University: Neonatal care, Dessie, Kombolcha, Ethiopia

Study Results

No Results Posted as of Dec 27, 2022