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

January 22, 2024 updated by: Matthew Thompson, University of Washington

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6995

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 4 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Paper-based CCM (Standard Care)
Children are assessed and treated according to the WHO and UNICEFs paper-based Community Case Management decision aid for Malawi for a minimum of 2 and a maximum of 7-weeks. Clinical assessment is guided by the paper-based 'Sick Child Form' presented in English, and clinical data is recorded by Health Surveillance Assistants manually in the Village Clinic Register.
Other: Standard care
Experimental: SL eCCM App + paper CCM
Health Surveillance Assistants use the Supporting LIFE electronic Community Case Management App (SL eCCM App) deployed on a smartphone and replicating paper-based CCM guidelines to assess and treat children in conjunction with standard care, for a minimum of 2-weeks and maximum of 7-weeks. Clinical data is recorded in both the SL eCCM App and Village Clinic Register.
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.
Other Names:
  • SL eCCM App

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health worker initiated referral of children to higher-level health facilities
Time Frame: at the index visit (study enrollment)
at the index visit (study enrollment)
Attendance/non-attendance of parent/caregivers given urgent referral recommendation at higher-level health facilities
Time Frame: 7-days post-enrollment
7-days post-enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Lund University
Imperial College London
University College Cork
Mzuzu University
Luke International Norway

Investigators

  • Principal Investigator: Matthew J Thompson, DPhil, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

February 28, 2017

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimated)

May 5, 2016

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51750

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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