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OpenTrials
Completed

NCT Number: NCT02763345

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

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.

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Key information

Conditions

Infectious Diseases Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supporting LIFE electronic Community Case Management

Other

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

Standard care

Other

Primary outcomes

  1. Health worker initiated referral of children to higher-level health facilities

    Time frame: at the index visit (study enrollment)

  2. Attendance/non-attendance of parent/caregivers given urgent referral recommendation at higher-level health facilities

    Time frame: 7-days post-enrollment

Secondary outcomes

  1. Barriers and facilitators to parent/caregiver compliance with referral recommendations

    Time frame: <2-weeks post-enrollment

  2. Acceptability of the SL eCCM App to HSAs and parents/caregivers

    Time frame: <2-weeks post-enrollment

  3. Household-level costs associated with healthcare seeking behavior

    Time frame: < 2-weeks post-enrollment

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 5, 2016
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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