Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02971449
Other study ID # BMAChartiableGrant2016
Secondary ID
Status Recruiting
Phase N/A
First received November 17, 2016
Last updated November 18, 2016
Start date November 2016
Est. completion date February 2017

Study information

Verified date November 2016
Source Omni Med
Contact Edward J O'Neil, MD
Email ejoneil@omnimed.org
Is FDA regulated No
Health authority Uganda: Research Ethics CommitteeUganda: National Council for Science and Technology
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date February 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 16 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Device:
Amazon Fire Tablet
A generic amazon fire tablet with pre-loaded instructional videos
Other:
ICCM Traditional Trainins
Standard, Didactic VHT Training intervention as an active comparator

Locations

Country Name City State
Uganda Omni Med Kisoga Mukono
United States Omni Med Newton Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Omni Med

Countries where clinical trial is conducted

United States,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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. 2 months No
See also
  Status Clinical Trial Phase
Completed NCT03574480 - Smartphone Applications to Improve Lifestyles in Olders Over 65 Years N/A
Not yet recruiting NCT04070066 - Educational Strategy IN Exchange Transfusion N/A
Active, not recruiting NCT05043220 - Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Systemic Cancer Therapy N/A
Recruiting NCT04045054 - Home-based Transitional Telecare for Older Veterans N/A
Completed NCT04652674 - Impact of Postoperative Telemedicine Visit vs In-person Visit on Patient Satisfaction During the COVID-19 Pandemic N/A
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Recruiting NCT05480930 - Improving Nighttime Access to Care and Treatment; Part 4-Haiti N/A
Completed NCT03025217 - Total Lifestyle Coaching Pilot Study (TLC) N/A
Completed NCT02196428 - Medical Telemonitoring Plus Individual Teleconsultation in Elderly N/A
Completed NCT01820234 - Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event N/A
Recruiting NCT04392518 - Telerehabilitation in Proximal Muscle Weakness N/A
Completed NCT05147038 - The Impact of Tele-coaching on the Physical Activity Level N/A
Not yet recruiting NCT06466837 - Just-In-Time Adaptive Interventions for Diabetic Patients N/A
Not yet recruiting NCT05897710 - Virtual World-Based Cardiac Rehabilitation N/A
Not yet recruiting NCT04444297 - 3D Telemedicine During COVID-19: Non-clinical Validation N/A
Not yet recruiting NCT04513496 - Telemedicine in HIV Care in Buenos Aires
Completed NCT05895539 - Evaluating Treatment Continuation in Telehealth Patients Receiving an Automated Patient-Reported Outcome Tool N/A
Active, not recruiting NCT03474692 - Virta Health Registry
Recruiting NCT05046392 - mHealth Facilitated Intervention to Improve Medication Adherence Among Persons Living With HIV N/A
Recruiting NCT05231018 - A Study on a Digital Platform for COVID19+ Patients, Designed to Facilitate Communication and Mental-health Care During and After Hospitalization. N/A