Clinical trial NCT02971449: Using mHealth Tools to Deliver Integrated Community Case Management (ICCM) to Village Health Team (VHT) Volunteers.
Official title: Using mHealth Tools to Deliver Integrated Community Case Management (ICCM) to Village Health Team (VHT) Volunteers in Uganda.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Community Health Services
Telemedicine
Keywords: Village Healthcare Team
mHealth
Telemedicine
Lead sponsor: Omni Med
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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?
timeFrame: 2 months
Secondary outcomes:
measure: Cost efficacy of the Tablet Approach to ICCM Training
timeFrame: 2 months
Other outcomes:
Locations:
city: Newton
country: United States
facility: Omni Med
state: Massachusetts
city: Kisoga
country: Uganda
facility: Omni Med
state: Mukono
Study officials:
affiliation: Omni Med
name: Edward J O'Neil Jr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Omni Med
name: James O'Donovan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.