The Added Value of a Mobile Application of Community Case Management on Pediatric Referral Rates in Malawi

Infectious Diseases Clinical Trial

Official title:

The Added Value of a Mobile Application of Community Case Management on Under-5 Referral, Re-consultation and Hospitalization Rates in Malawi: a Pragmatic Stepped-wedge Cluster Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763345
• Other study ID #: 51750
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: January 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Community Case Management (CCM) is a clinical decision aid used by frontline Health Surveillance Assistants (HSAs) in Malawi to manage uncomplicated cases of pneumonia and malaria (amongst other conditions). Children identified has having complicated illness are urgently referred to larger health facilities better equipped to clinically manage these more complex presentations. There is evidence to suggest HSAs are missing opportunities to refer seriously ill children, and parents/caregivers are failing to comply with urgent referral recommendations when given; reducing the overall effectiveness of the CCM strategy. Use of mobile technology for deploying CCM has been demonstrated in prior research as feasible to evaluate, acceptable to health workers and parents/caregivers and improving health worker fidelity to the guidelines, but it is unknown if this translates into increased referral and referral completion rates. This trial seeks to evaluate the added value of a purpose developed mobile solution for CCM, called Supporting LIFE electronic Community Case Management (SL eCCM App) on HSA referral and parent/caregiver health seeking behavior.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6995
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 59 Months

Eligibility

Inclusion Criteria:

• Parents/caregivers aged =18 years with spoken fluency in Chichewa, Tonga and Tumbuka

• Children aged =2 months to <5 years

• Able/willing to give voluntary verbal consent

Exclusion Criteria:

• Parents/caregivers aged <18 years

• Children aged <2 months or =5 years

• Children who are convulsing or unconscious/unresponsive at presentation

• Parents/caregivers unable/unwilling to give voluntary verbal consent

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Diseases

Intervention

Other:
• Supporting LIFE electronic Community Case Management
The SL eCCM App is smartphone application developed to run on Android operating systems 3.0 Honeycomb and above. The SL eCCM App represents an electronic format of the WHO and UNICEFs paper-based CCM clinical decision rule, currently adopted as national policy in Malawi for assessing children presenting to village clinics with acute illness.The App includes a tap-sensitive breath counter for measuring breathing rate.
• Standard care

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
University of Washington	Imperial College London, Luke International Norway, Lund University, Mzuzu University, University College Cork

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health worker initiated referral of children to higher-level health facilities		at the index visit (study enrollment)
Primary	Attendance/non-attendance of parent/caregivers given urgent referral recommendation at higher-level health facilities		7-days post-enrollment
Secondary	Barriers and facilitators to parent/caregiver compliance with referral recommendations		<2-weeks post-enrollment
Secondary	Acceptability of the SL eCCM App to HSAs and parents/caregivers		<2-weeks post-enrollment
Secondary	Household-level costs associated with healthcare seeking behavior		< 2-weeks post-enrollment