MalariaNCT06318078
Buikwe Electronic Community Health Information System Impact Study
A study testing eCHIS in people with Malaria and Diarrhea, run by Malaria Consortium at 1 site in Uganda.
Trial summary
The purpose of the study is to investigate the impact of the eCHIS intervention on key child health outcomes. Read more about this study
- Who is it for?
- Ages 3 to 59 months
- What is being tested?
- eCHIS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,140 participants
- Where
- 1 siteUganda
- Study dates
- 1 Dec 2023to Jul 2024
- 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 3 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- · Children between 3-59 months,
- Being resident in the study area,
- Consent to participate in the study obtained,
- Willingness and ability of the child's guardians to comply with the study protocol for the duration of the study including attending a designated health centre if their child has malaria symptoms during the data collection period.
Who cannot join
- Children aged below 3 months and above 59 months
- Children resident outside the study areas
- Those who have not consented to participate in the study
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Buikwe
Buikwe
John Baptist Bwanika, MD
John Baptist Bwanika, MD
About this study
Official title: A Research Study to Understand the Impact and Cost-effectiveness of a Digital Health Platform for iCCM in Uganda
The purpose of the study is to investigate the impact of the eCHIS intervention on key child health outcomes.
Read the detailed description
Following national guidelines, 2 VHTs per village will be supported to provide the full eCHIS community health package. In total 856 VHTs in Buikwe district will have been trained and equipped with the national strategy and operational guidelines on eCHIS as well as the VHT full package (iCCM+ and VHT basic package (reproductive health, immunization, nutrition) guidelines. The VHTs will be equipped with mobile devices and iCCM supplies to start the management of community-based health among children aged five years within their respective communities. A cross-sectional cluster randomized controlled trial (cRCT) will be used to establish study outcomes in children under 5 years in the intervention and control areas using mixed methods (qualitative and quantitative) of data collection.
A total sample size of 1,140 children under five: 570 children under five, per arm, was scientifically determined for the study. During data collection, several quality control measures will be applied to ensure the data recorded reflect the facts, responses, observations, and events. A standard operating procedure (SOP) with roles and responsibilities of the data collectors will be prepared to ensure standardized methods for capturing data. After endline data collection, difference-in-differences (DID) analysis will be done to derive an estimate of the intervention effect on odds of the study outcomes.
Results will be disseminated through agreed peer-review publications and international conferences. Malaria Consortium Uganda will work with relevant stakeholders at the Ministry of Health and Medic Mobile to disseminate findings nationally and throughout the study district.
- Being tested
- eCHIS
- Medical subject headings
- Malaria, Diarrhea, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCHISOther
The electronic Community health Information System (eCHIS) is a Government of Uganda owned application used by community health workers for quality health assessments and improved reporting. The eCHIS intervention allows for the registration of longitudinal profiles for client centered care as well as provides care guidance to aid decision making. For its users, the app has a task tab for schedule management and dashboards for performance help management and impact tracking by supervisors. This app is interoperable with national reporting tools such as DHIS2. The app has ten workflows including registration of households and new persons, death reporting, iCCM assessment, treatment and referral follow up, stock monitoring, data synchronization, pregnancy registration, ANC danger signs and follow up, family planning registration, and screening (tuberculosis, hypertension, sickle cell, tobacco use and net use).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 570 children will be allocated to the intervention arm and children in this arm will be assessed using the eCHIS digital tool. Receives: Other: eCHIS |
| Control | No intervention | 570 children will be allocated to the intervention arm and children in this arm will be assessed using the standard care and paper based tools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Out Patient Department attendance (due to malaria, pneumonia and diarrhoea)
Attendance measured through baseline and endline surveys
Measured: Over 1 year
Hospitalisation (due to malaria, pneumonia and diarrhoea)
Attendance measured through baseline and endline surveys
Measured: Over 1 year
malaria related mortality in the community and health facilities
Malaria related mortality measured through routine data
Measured: Over 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Dec 2023
- Primary completionApr 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- Model description
- Cluster Randomised Control Trial
- Masking
- None (open label)
- Enrolment
- 1,140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malaria Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Baptist Bwanika, Principal investigator, Malaria Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318078
- Sponsor's protocol ID
- UG2024001
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research Study to Understand the Impact and Cost-effectiveness of a Digital Health Platform for iCCM in Uganda
- ClinicalTrials.gov ID
- NCT06318078
- Acronym / sponsor ID
- UG2024001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,140 participants (estimated)
- Lead sponsor
- Malaria ConsortiumUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 19 Mar 2024 (actual)
- 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.
The purpose of the study is to investigate the impact of the eCHIS intervention on key child health outcomes.
Detailed description
Following national guidelines, 2 VHTs per village will be supported to provide the full eCHIS community health package. In total 856 VHTs in Buikwe district will have been trained and equipped with the national strategy and operational guidelines on eCHIS as well as the VHT full package (iCCM+ and VHT basic package (reproductive health, immunization, nutrition) guidelines. The VHTs will be equipped with mobile devices and iCCM supplies to start the management of community-based health among children aged five years within their respective communities. A cross-sectional cluster randomized controlled trial (cRCT) will be used to establish study outcomes in children under 5 years in the intervention and control areas using mixed methods (qualitative and quantitative) of data collection.
A total sample size of 1,140 children under five: 570 children under five, per arm, was scientifically determined for the study. During data collection, several quality control measures will be applied to ensure the data recorded reflect the facts, responses, observations, and events. A standard operating procedure (SOP) with roles and responsibilities of the data collectors will be prepared to ensure standardized methods for capturing data. After endline data collection, difference-in-differences (DID) analysis will be done to derive an estimate of the intervention effect on odds of the study outcomes.
Results will be disseminated through agreed peer-review publications and international conferences. Malaria Consortium Uganda will work with relevant stakeholders at the Ministry of Health and Medic Mobile to disseminate findings nationally and throughout the study district.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster Randomised Control Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: eCHIS570 children will be allocated to the intervention arm and children in this arm will be assessed using the eCHIS digital tool. |
| Control | No intervention | –570 children will be allocated to the intervention arm and children in this arm will be assessed using the standard care and paper based tools. |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- · Children between 3-59 months,
Key exclusion criteria (3 listed)
- Children aged below 3 months and above 59 months
- Children resident outside the study areas
- Those who have not consented to participate in the study
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 |
|---|---|---|
| eCHISThe electronic Community health Information System (eCHIS) is a Government of Uganda owned application used by community health workers for quality health assessments and improved reporting. The eCHIS intervention allows for the registration of longitudinal profiles for client centered care as well as provides care guidance to aid decision making. For its users, the app has a task tab for schedule management and dashboards for performance help management and impact tracking by supervisors. This app is interoperable with national reporting tools such as DHIS2. The app has ten workflows including registration of households and new persons, death reporting, iCCM assessment, treatment and referral follow up, stock monitoring, data synchronization, pregnancy registration, ANC danger signs and follow up, family planning registration, and screening (tuberculosis, hypertension, sickle cell, tobacco use and net use). | Other | Intervention |
Primary outcome
Out Patient Department attendance (due to malaria, pneumonia and diarrhoea)
Time frame: Over 1 year
Attendance measured through baseline and endline surveys
Hospitalisation (due to malaria, pneumonia and diarrhoea)
Time frame: Over 1 year
Attendance measured through baseline and endline surveys
malaria related mortality in the community and health facilities
Time frame: Over 1 year
Malaria related mortality measured through routine data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- 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.
John Baptist Bwanika principal investigator
Malaria Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eCHIS in people with Malaria and Diarrhea, run by Malaria Consortium at 1 site in Uganda.
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 4 inclusion and 3 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 John Baptist Bwanika (+256 772744390, j.bwanika@malariaconsortium.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Out Patient Department attendance (due to malaria, pneumonia and diarrhoea) (time frame: Over 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2024.