search
Back to results

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

Primary Purpose

Infectious Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supporting LIFE electronic Community Case Management
Standard care
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infectious Diseases

Eligibility Criteria

2 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Paper-based CCM (Standard Care)

    SL eCCM App + paper CCM

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Health worker initiated referral of children to higher-level health facilities
    Attendance/non-attendance of parent/caregivers given urgent referral recommendation at higher-level health facilities

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 3, 2016
    Last Updated
    May 2, 2017
    Sponsor
    University of Washington
    Collaborators
    Imperial College London, University College Cork, Lund University, Mzuzu University, Luke International Norway
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02763345
    Brief Title
    The Added Value of a Mobile Application of Community Case Management on Pediatric Referral Rates in Malawi
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    February 28, 2017 (Actual)
    Study Completion Date
    February 28, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington
    Collaborators
    Imperial College London, University College Cork, Lund University, Mzuzu University, Luke International Norway

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infectious Diseases

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    6995 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Paper-based CCM (Standard Care)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    SL eCCM App + paper CCM
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Supporting LIFE electronic Community Case Management
    Other Intervention Name(s)
    SL eCCM App
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Standard care
    Primary Outcome Measure Information:
    Title
    Health worker initiated referral of children to higher-level health facilities
    Time Frame
    at the index visit (study enrollment)
    Title
    Attendance/non-attendance of parent/caregivers given urgent referral recommendation at higher-level health facilities
    Time Frame
    7-days post-enrollment
    Secondary Outcome Measure Information:
    Title
    Barriers and facilitators to parent/caregiver compliance with referral recommendations
    Time Frame
    <2-weeks post-enrollment
    Title
    Acceptability of the SL eCCM App to HSAs and parents/caregivers
    Time Frame
    <2-weeks post-enrollment
    Title
    Household-level costs associated with healthcare seeking behavior
    Time Frame
    < 2-weeks post-enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    59 Months
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Matthew J Thompson, DPhil
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34668872
    Citation
    Chirambo GB, Thompson M, Hardy V, Ide N, Hwang PH, Dharmayat K, Mastellos N, Heavin C, O'Connor Y, Muula AS, Andersson B, Carlsson S, Tran T, Hsieh JC, Lee HY, Fitzpatrick A, Joseph Wu TS, O'Donoghue J. Effectiveness of Smartphone-Based Community Case Management on the Urgent Referral, Reconsultation, and Hospitalization of Children Aged Under 5 Years in Malawi: Cluster-Randomized, Stepped-Wedge Trial. J Med Internet Res. 2021 Oct 20;23(10):e25777. doi: 10.2196/25777.
    Results Reference
    derived
    PubMed Identifier
    29020976
    Citation
    Hardy V, O'Connor Y, Heavin C, Mastellos N, Tran T, O'Donoghue J, Fitzpatrick AL, Ide N, Wu TJ, Chirambo GB, Muula AS, Nyirenda M, Carlsson S, Andersson B, Thompson M. The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial. Trials. 2017 Oct 11;18(1):475. doi: 10.1186/s13063-017-2213-z.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs