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Clinical Evaluation of the Use of an mHealth Intervention on Quality of Care

Primary Purpose

Malaria, Diarrhea, Acute Respiratory Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mHealth Intervention for Quality of Care
Sponsored by
World Vision Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Malaria

Eligibility Criteria

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

Inclusion Criteria:

  • children presenting symptoms of illness

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    RCom equipped with a smartphone

    RCom with paper-based system

    Arm Description

    Outcomes

    Primary Outcome Measures

    Quality of Care (QoC) provided by RCom
    The maximum QoC score was 31 points; the score was weighted with two-thirds of the score allocated to screening questions and correct identification of the danger signs and signs/symptoms of serious conditions A perfect score was achieved when RComs asked all 10 health screening questions and correctly classified 4 major danger signs and 6 serious symptoms, made appropriate referral, and provided advice to caregivers.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 26, 2019
    Last Updated
    March 11, 2019
    Sponsor
    World Vision Canada
    Collaborators
    World Health Organization, Ministry of Public Health Niger, Toronto Metropolitan University, Global Affairs Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03874143
    Brief Title
    Clinical Evaluation of the Use of an mHealth Intervention on Quality of Care
    Official Title
    Clinical Evaluation of the Use of an mHealth Intervention on Quality of Care Provided by Community Health Workers in Southwest Niger
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2016 (Actual)
    Primary Completion Date
    October 1, 2016 (Actual)
    Study Completion Date
    October 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    World Vision Canada
    Collaborators
    World Health Organization, Ministry of Public Health Niger, Toronto Metropolitan University, Global Affairs Canada

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Under the World Health Organization's (WHO) integrated community case management (iCCM) Rapid Access Expansion Program (RAcE), World Vision Niger and Canada supported the Niger Ministry of Public Health to implement iCCM in four health districts in Niger in 2013. Community health workers (CHWs), known as Relais Communautaire (RCom), were deployed in their communities to diagnose and treat children under five years of age presenting with diarrhea, malaria and pneumonia and refer children with severe illness to the higher-level facilities. Two of the districts piloted RCom using smartphones equipped with an application to support quality case management and provide good timely clinical data. A two-arm cluster randomized trial assessed the impact of use of the mHealth application mainly on quality of care (QoC), but also on motivation, retention and supervision

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malaria, Diarrhea, Acute Respiratory Infection

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    520 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RCom equipped with a smartphone
    Arm Type
    Experimental
    Arm Title
    RCom with paper-based system
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    mHealth Intervention for Quality of Care
    Intervention Description
    Does use of a specially equipped smartphone make a difference in the diagnosis and treatment by RCom of malaria, pneumonia and diarrhea in children aged 2 to 59 months
    Primary Outcome Measure Information:
    Title
    Quality of Care (QoC) provided by RCom
    Description
    The maximum QoC score was 31 points; the score was weighted with two-thirds of the score allocated to screening questions and correct identification of the danger signs and signs/symptoms of serious conditions A perfect score was achieved when RComs asked all 10 health screening questions and correctly classified 4 major danger signs and 6 serious symptoms, made appropriate referral, and provided advice to caregivers.
    Time Frame
    30 weeks

    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: children presenting symptoms of illness Exclusion Criteria: -

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Evaluation of the Use of an mHealth Intervention on Quality of Care

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