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

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ClinicalTrials.gov Identifier: NCT02763345
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : May 5, 2017
Sponsor:
Collaborators:
Imperial College London
University College Cork
Lund University
Mzuzu University
Luke International Norway
Information provided by (Responsible Party):
Matthew Thompson, University of Washington

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.

Condition or disease Intervention/treatment Phase
Infectious Diseases Device: Supporting LIFE electronic Community Case Management Other: Standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6995 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : October 2016
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

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.
Device: 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 Name: SL eCCM App




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763345


Sponsors and Collaborators
University of Washington
Imperial College London
University College Cork
Lund University
Mzuzu University
Luke International Norway
Investigators
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Principal Investigator: Matthew J Thompson, DPhil University of Washington

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthew Thompson, Professor, Department of Family Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT02763345     History of Changes
Other Study ID Numbers: 51750
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Communicable Diseases
Infection