CClinicalTrials.gg
Status unknownNCT02971449Updated Nov 23, 2016

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

An interventional study of Amazon Fire Tablet and ICCM Traditional Trainins in Community Health Services and Telemedicine, sponsored by Omni Med. Status unknown at 2 sites in 2 countries. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-23.

Sponsored by Omni Med · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Community Health Services
  • Telemedicine

Keywords

  • Village Healthcare Team
  • mHealth
  • Telemedicine
03

In context

Lead sponsor

This is the only study on the registry with Omni Med as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Unregistered VHTs
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceAmazon Fire Tablet

    A generic amazon fire tablet with pre-loaded instructional videos

  • OtherICCM Traditional Trainins

    Standard, Didactic VHT Training intervention as an active comparator

06

What researchers measure

Primary outcomes

  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?

    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.

    Time frame: 2 months

Secondary outcomes

  1. Cost efficacy of the Tablet Approach to ICCM Training

    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.

    Time frame: 2 months

07

Study locations

2 of 2 sites recruiting
  • Omni Med
    Newton, Massachusetts 02468, United States
    • Edward J O'Neil Jr., MD · Contact · ejoneil@omnimed.org · 617-332-9614
    • Keneth Kabali, MD · Contact · kenkysy@yahoo.com · +256-772-585-830
    • Edward J O'Neil Jr, MD · Principal investigator
    • Benjamin J Lough, PhD · Sub investigator
    • James O'Donovan, MD · Principal investigator
    Recruiting
  • Omni Med
    Kisoga, Mukono, Uganda
    • Kenneth Kabali, MD · Contact · kenkysy@yahoo.com · +256-772-585-830
    • Edward M Mwebe · Contact · edward.mutimba@gmail.com · +256782316612
    • James O'Donovan, MD · Principal 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 · Sub investigator
    Recruiting
08

References and documents

Publications

  • O'Donovan J, Kabali K, Taylor C, Chukhina M, Kading JC, Fuld J, O'Neil E. The use of low-cost Android tablets to train community health workers in Mukono, Uganda, in the recognition, treatment and prevention of pneumonia in children under five: a pilot randomised controlled trial. Hum Resour Health. 2018 Sep 19;16(1):49. doi: 10.1186/s12960-018-0315-7. PubMed 30231894 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02971449
Lead sponsor
Omni Med
Responsible party
Sponsor
First posted
Nov 23, 2016
Start date
Nov 2016
Primary completion
Dec 2016 (estimated)
Completion
Feb 2017 (estimated)
Last update
Nov 23, 2016

Study contacts

Edward J O'Neil, MD
Contact
ejoneil@omnimed.org
James J O'Donovan, MBBS
Contact
jamesodonovan@post.harvard.edu
Edward J O'Neil Jr, MD
principal investigator · Omni Med
James O'Donovan, MD
principal investigator · Omni Med

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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