Mobile Health Intervention to Improve Neonatal Care Practice (NCP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Care
• Intervention / Treatment: Behavioral: Mobile health intervention

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 Type: Interventional
• Enrollment (Anticipated): 784
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Niguss Cherie, MPH; Phone Number: 0910749743; Email: nigucheru@gmail.com
• Study Contact Backup: Name: Mulemebet Abera, PhD; Phone Number: +251985171738; Email: mulu_abera.ts2009@yahoo.com

Study Locations

• Ethiopia
  • South Wollo
    • Dessie, South Wollo, Ethiopia, 1145
      • Recruiting
      • Dessie and Kombolcha
      • Contact: Niguss Cherie; Phone Number: 0910749743; Email: nigucheru@gmail.com
      • Contact: Muluemebet Abera, PhD; Phone Number: +251985171738; Email: mulu_abera.ts2009@yahoo.com
      • Sub-Investigator: Gurmesa Tura, Proffessor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Two weeks after intervention the outcome will be measured.

Collaborators and Investigators

• Sponsor: Wollo University
• Collaborators: Jimma University
• Investigators: Principal Investigator: Niguss Cherie, Wollo Universirty

Publications and helpful links

General Publications

• Cherie N, Abdulkerim M, Abegaz Z, Walle Baze G. Maternity continuum of care and its determinants among mothers who gave birth in Legambo district, South Wollo, northeast Ethiopia. Health Sci Rep. 2021 Nov 2;4(4):e409. doi: 10.1002/hsr2.409. eCollection 2021 Dec.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Anticipated): April 25, 2023
• Study Completion (Anticipated): April 25, 2023

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Neonatal care, Dessie, Kombolcha, Ethiopia
• Other Study ID Numbers: JUIH/IRB/230/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data from the participants will be confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No