Community Health ServicesNCT02971449
Using mHealth Tools to Deliver Integrated Community Case Management (ICCM) to Village Health Team (VHT) Volunteers.
A study testing Amazon Fire Tablet and ICCM Traditional Trainins in people with Community Health Services and Telemedicine, run by Omni Med at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community Health Services, Telemedicine
- What is being tested?
- Amazon Fire Tablet and ICCM Traditional Trainins
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unregistered VHTs
Trial locations and contacts
2 sites in 2 countries.
Edward J O'Neil, MD contact
James J O'Donovan, MBBS contact
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Omni Med
Newton, Massachusetts, 02468
Edward J O'Neil Jr., MD, 617-332-9614, ejoneil@omnimed.org
Keneth Kabali, MD, +256-772-585-830, kenkysy@yahoo.com
Uganda1 site, 1 recruiting
- Recruiting
Omni Med
Kisoga, Mukono
Kenneth Kabali, MD, +256-772-585-830, kenkysy@yahoo.com
Edward M Mwebe, +256782316612, edward.mutimba@gmail.com
About this study
Official title: Using mHealth Tools to Deliver Integrated Community Case Management (ICCM) to Village Health Team (VHT) Volunteers in Uganda.
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.
- Conditions
- Community Health Services, Telemedicine
- Being tested
- Amazon Fire Tablet, ICCM Traditional Trainins
- Keywords
- Village Healthcare Team, mHealth, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amazon Fire TabletDevice
A generic amazon fire tablet with pre-loaded instructional videos
ICCM Traditional TraininsOther
Standard, Didactic VHT Training intervention as an active comparator
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: ICCM Traditional Trainins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community Health ServicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omni Med
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward J O'Neil Jr, MD, Principal investigator, Omni MedJames O'Donovan, MD, Principal investigator, Omni Med
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971449
- Sponsor's protocol ID
- BMAChartiableGrant2016
- Status last verified
- Nov 2016
- First submitted
- 17 Nov 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using mHealth Tools to Deliver Integrated Community Case Management (ICCM) to Village Health Team (VHT) Volunteers in Uganda.
- ClinicalTrials.gov ID
- NCT02971449
- Acronym / sponsor ID
- BMAChartiableGrant2016
- Conditions
- Community Health Services, Telemedicine
- Keywords
- Village Healthcare Team, mHealth, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Omni MedUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablets only | Experimental | Device: Amazon Fire Tablet100 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 |
| ICCM traditional training | Active comparator | Other: ICCM Traditional Trainins100 VHTs will receive traditional 1 day 'in-person' training as an active comparator intervention, but participants in this arm will not receive any tablets |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Unregistered VHTs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amazon Fire TabletA generic amazon fire tablet with pre-loaded instructional videos | Device | Tablets only |
| ICCM Traditional TraininsStandard, Didactic VHT Training intervention as an active comparator | Other | ICCM traditional training |
Primary outcome
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.
1 secondary outcome
Cost efficacy of the Tablet Approach to ICCM Training
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Derived from this study: PubMed 30231894O'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward J O'Neil, MD contact
James J O'Donovan, MBBS contact
Edward J O'Neil Jr, MD principal investigator
Omni Med
James O'Donovan, MD principal investigator
Omni Med
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amazon Fire Tablet and ICCM Traditional Trainins in people with Community Health Services and Telemedicine, run by Omni Med at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edward J O'Neil, MD (ejoneil@omnimed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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? (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02971449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2016.