NCT02971449

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

1 month

First QC Date

November 17, 2016

Last Update Submit

November 18, 2016

Conditions

Community Health ServicesTelemedicine

Keywords

Village Healthcare TeammHealthTelemedicine

Outcome Measures

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.

    2 months

Secondary Outcomes (1)

  • Cost efficacy of the Tablet Approach to ICCM Training

    2 months

Study Arms (2)

Tablets only

EXPERIMENTAL

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

ICCM traditional training

ACTIVE COMPARATOR

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

Amazon Fire TabletDEVICE

A generic amazon fire tablet with pre-loaded instructional videos

Tablets only
ICCM Traditional TraininsOTHER

Standard, Didactic VHT Training intervention as an active comparator

ICCM traditional training

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Unregistered VHTs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Omni Med

Newton, Massachusetts, 02468, United States

RECRUITING

Omni Med

Kisoga, Mukono, Uganda

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30231894DERIVED

Study Officials

  • Edward J O'Neil Jr, MD

    Omni Med

    PRINCIPAL INVESTIGATOR

  • James O'Donovan, MD

    Omni Med

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward J O'Neil, MD

CONTACT

ejoneil@omnimed.org

James J O'Donovan, MBBS

CONTACT

jamesodonovan@post.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 23, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

November 23, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)UG(1)