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
|Condition or disease||Intervention/treatment||Phase|
|Infectious Diseases||Device: Supporting LIFE electronic Community Case Management Other: Standard care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6995 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Health worker initiated referral of children to higher-level health facilities [ Time Frame: 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 ]
- Barriers and facilitators to parent/caregiver compliance with referral recommendations [ Time Frame: <2-weeks post-enrollment ]
- Acceptability of the SL eCCM App to HSAs and parents/caregivers [ Time Frame: <2-weeks post-enrollment ]
- Household-level costs associated with healthcare seeking behavior [ Time Frame: < 2-weeks post-enrollment ]
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
|Principal Investigator:||Matthew J Thompson, DPhil||University of Washington|