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Using mHealth Tools to Deliver Integrated Community Case Management (ICCM) to Village Health Team (VHT) Volunteers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02971449
Recruitment Status : Unknown
Verified November 2016 by Omni Med.
Recruitment status was:  Recruiting
First Posted : November 23, 2016
Last Update Posted : November 23, 2016
Information provided by (Responsible Party):
Omni Med

Brief Summary:
This study compares the traditional, didactic method of training Ugandan community health workers with training using tablets in pneumonia management, a common, life-threatening illness in children in rural areas.

Condition or disease Intervention/treatment Phase
Community Health Services Telemedicine Device: Amazon Fire Tablet Other: ICCM Traditional Trainins Not Applicable

Detailed Description:

Current ICCM (Integrated Community Case Management) training in Uganda involves CHWs physically attending a five-day workshop, which is both expensive, time consuming and requires trainer's to be physically present to deliver training materials. The investigators hypothesize that use of a low-cost android tablet, with pre-loaded instructional educational videos will improve the baseline knowledge and retention of knowledge of CHWs as well as lower the direct and indirect costs of ICCM training.

The investigators will conduct a randomized controlled trial in two sub-counties in Mukono district among CHWs to test these two hypotheses. In this study, the investigators will focus solely on the pneumonia component of ICCM training, instead of testing the full week-long training course including malaria, pneumonia, and diarrhea. (The investigators plan a later trial encompassing the entire week-long training vs the same uploaded into the tablets.) The investigators will enroll 200 CHWs in the study, with 100 in a control group who will receive a one day in-person training session focusing on pneumonia, similar to traditional ICCM training and 100 in an intervention group who will receive tablets with instructional training videos. The investigators will administer a written test prior to the training in both groups, then administer the same written test one week later. Additionally, the investigators will test both groups with clinical case scenarios that give these community health workers realistic clinical cases and challenge them to diagnose pneumonia, state whether patient should be treated in the home or brought to hospital, and how to initiate and complete management if patients are to be referred or kept home, respectively. The sample sizes will enable the investigators carry out independent t-tests and a paired two-sample t-test to determine the significance of pre- and post-test scores for the control and intervention groups. If training delivered via low-cost android tablets proves to be both effective and acceptable, this option may represent a viable, scalable and cost-effective alternative to the traditional training model used throughout Uganda.

Furthermore, the MoH could institute an incentive policy that allows tablets to be distributed and retained by health workers provided that they maintain a quarterly flow of information back to the MoH regarding home visits, patients referred, or other community actions. Should the learning and cost efficacy prove viable, the investigators can envision tablets throughout Mukono District, allowing the more direct transfer of information, disease patterns, index cases of pathogens like Ebola, tracking of data for the Ministry, regular dissemination of training materials, and opportunities for CHWs gain employment in the health sector.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Using mHealth Tools to Deliver Integrated Community Case Management (ICCM) to Village Health Team (VHT) Volunteers in Uganda.
Study Start Date : November 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: Tablets only
100 VHTs will receive Amazon Fire Tablets with pre-loaded instructional videos; this is the intervention arm since this involves introduction of a new technology to this realm
Device: Amazon Fire Tablet
A generic amazon fire tablet with pre-loaded instructional videos

Active Comparator: ICCM traditional training
100 VHTs will receive traditional 1 day 'in-person' training as an active comparator intervention, but participants in this arm will not receive any tablets
Other: ICCM Traditional Trainins
Standard, Didactic VHT Training intervention as an active comparator

Primary Outcome Measures :
  1. Is VHT knowledge retention comparable or superior when comparing the use of tablets with standard Ugandan ICCM training methods in the recognition and management of pneumonia in children by Ugandan VHTs? [ Time Frame: 2 months ]
    There will be 2 arms of the study to see if pre-loaded instructional videos on a low cost android tablet are either superior to or comparable to standard training methods in the training of VHTs in Mukono, Uganda in terms of recognition, prevention and management of pneumonia in children under 5 years old in line with ICCM guidelines. One group will receive normal ICCM training by attending the standard, didactic ICCM training workshop held in the community. The second, Interventional arm will utilize Ministry approved training videos pre-loaded into low cost android tablets. The overall aim of the study is to assess whether or not the tablets can replace the current time-consuming and expensive methods used throughout Uganda.

Secondary Outcome Measures :
  1. Cost efficacy of the Tablet Approach to ICCM Training [ Time Frame: 2 months ]
    We will perform detailed cost analysis for both arms of this trial. Generally, it is expensive to bring a group of VHTs together for trainings, with costs including transport, food, instructors, petrol, and materials. By contrast, getting tablets out to VHTs with simple user instructions allows learning to happen at home, and repeatedly by watching the videos over and over again.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Must be a registered VHT working in the study areas in Uganda;
  • Must express a commitment to aim to complete the duration of the study;
  • Willingness to be randomised to the control or intervention group.

Exclusion Criteria:

- Unregistered VHTs

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 identifier (NCT number): NCT02971449

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Contact: Edward J O'Neil, MD
Contact: James J O'Donovan, MBBS

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United States, Massachusetts
Omni Med Recruiting
Newton, Massachusetts, United States, 02468
Contact: Edward J O'Neil Jr., MD    617-332-9614   
Contact: Keneth Kabali, MD    +256-772-585-830   
Principal Investigator: Edward J O'Neil Jr, MD         
Sub-Investigator: Benjamin J Lough, PhD         
Principal Investigator: James O'Donovan, MD         
Omni Med Recruiting
Kisoga, Mukono, Uganda
Contact: Kenneth Kabali, MD    +256-772-585-830   
Contact: Edward M Mwebe    +256782316612   
Principal Investigator: James O'Donovan, MD         
Sub-Investigator: Edward J O'Neil Jr, MD         
Sub-Investigator: Kenneth Kabali, MD         
Sub-Investigator: Margarita Chukhina, MPH         
Sub-Investigator: Alan Penman, MD, MPH         
Sub-Investigator: Jacqueline Kading, BS         
Sub-Investigator: Edward M Mwebe         
Sponsors and Collaborators
Omni Med
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Principal Investigator: Edward J O'Neil Jr, MD Omni Med
Principal Investigator: James O'Donovan, MD Omni Med

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Omni Med Identifier: NCT02971449     History of Changes
Other Study ID Numbers: BMAChartiableGrant2016
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Omni Med:
Village Healthcare Team