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Universal Coverage Mode RCT

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ClinicalTrials.gov Identifier: NCT04106921
Recruitment Status : Completed
First Posted : September 27, 2019
Last Update Posted : September 27, 2019
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Medic Mobile
Information provided by (Responsible Party):
Ari Johnson, MD, University of California, San Francisco

Brief Summary:

Community Health Workers that work in collaboration with the NGO Muso Health and the Malian government in both a peri-urban and a rural site in Mali, provide care proactively to the population they form part of.

To work, they use a smartphone application that was developed as a job aid to support task management, panel management and clinical decision support functions. For this study, a tool called "Universal Health Coverage Mode" was designed to be integrated into the CHW application to help Community Health Workers visit every household at least twice per month.

We hypothesize that Community Health Workers (CHWs) assigned to use Universal Health Coverage (UHC) Mode, a mobile application tool, will achieve higher coverage of homes visited (defined as being visited at least two times in a month) than those without this tool.


Condition or disease Intervention/treatment Phase
Community Health Workers Other: Universal Health Coverage Mode Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Difference in differences parallel randomized controlled trial.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of a Mobile Application Tool for Increasing Community Health Worker Home Visit Coverage: A Randomized Controlled Study
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : July 26, 2019
Actual Study Completion Date : July 26, 2019

Arm Intervention/treatment
Experimental: Universal Health Coverage Mode
The NGOs Muso and Medic Mobile have partnered to develop Universal Health Coverage Mode, a smartphone app tool that provides visual cues to help CHWs track the quantity of household visits they have conducted at each household in a given month.
Other: Universal Health Coverage Mode

In the intervention arm, the CHW's household list will appear differently within the app in the following ways:

The CHW will be able to filter and order households by the date of the most recent home visit.

A color-coded visual icon will display the number of home visits in the past month for each household.

A red exclamation mark will be displayed for every household that has not reached 2 visits in the past month (default at the start of every month).

Text displayed below each household showing the date of last visit will turn red if more than 30 days have passed since last visit. When more than 60 days have passed since the most recent visit, the text displayed below each household showing the date of last visit will be changed to "date of last visit is unknown" in red.

The family profile will also contain the date of last visit, and the visits they have received in that month


No Intervention: Work as usual
For the control arm, all households within the CHW's household list in the app will have the same appearance. There will be no visual differentiation between households on the list to indicate the frequency of home visits.



Primary Outcome Measures :
  1. Primary outcome [ Time Frame: 4 months ]
    The probability of a household receiving two or more visits per "workflow" month (a month being from the 26th of one month to the 25th of the next month).


Secondary Outcome Measures :
  1. Secondary outcome 1 [ Time Frame: 4 months ]
    Number of days between household visits for each household served by CHWs

  2. Secondary outcome 2 [ Time Frame: 4 months ]
    Number of visits per household per "workflow"month

  3. Secondary outcome 3 [ Time Frame: 4 months ]
    Percentage of sick individuals in a household visited within 24 hours (among households with a sick person).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Community Health Workers serving the Tori (n=27) and Yirimadio (n=172) catchment areas conducting proactive home visits will be eligible to participate in the study

Exclusion Criteria:

  • CHWs involved in pilot-testing UHC Mode prior to the trial will be excluded from the trial.

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): NCT04106921


Locations
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Mali
Muso
Bamako, Mali
Sponsors and Collaborators
Ari Johnson, MD
Bill and Melinda Gates Foundation
Medic Mobile
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ari Johnson, MD, MD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04106921    
Other Study ID Numbers: 0219-0619
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ari Johnson, MD, University of California, San Francisco:
community health workers
primary health care
mobile applications