Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02763345
Enrollment
6995
Registered
2016-05-05
Start date
2016-10-31
Completion date
2017-02-28
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Diseases

Brief 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.

Interventions

OTHERSupporting 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.

OTHERStandard care

Sponsors

Imperial College London
CollaboratorOTHER
University College Cork
CollaboratorOTHER
Lund University
CollaboratorOTHER
Mzuzu University
CollaboratorUNKNOWN
Luke International Norway
CollaboratorUNKNOWN
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Months to 59 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Health worker initiated referral of children to higher-level health facilitiesat the index visit (study enrollment)
Attendance/non-attendance of parent/caregivers given urgent referral recommendation at higher-level health facilities7-days post-enrollment

Secondary

MeasureTime frame
Barriers and facilitators to parent/caregiver compliance with referral recommendations<2-weeks post-enrollment
Acceptability of the SL eCCM App to HSAs and parents/caregivers<2-weeks post-enrollment
Household-level costs associated with healthcare seeking behavior< 2-weeks post-enrollment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026