Acute DiarrheaINACT2NCT03943654
Improving Nighttime Access to Care and Treatment (Part 2)
An observational study of Acute Diarrhea and Acute Respiratory Infection, run by University of Florida at 1 site in Haiti.
Trial summary
Children in resource-limited settings who develop illness at night are often isolated from pre-emergency care, resulting in progression to an emergency because families are forced to wait until morning to seek care. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Acute Diarrhea, Acute Respiratory Infection, Acute Febrile Illness
- What is being tested?
- MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone
- How many people
- 391 participants
- Where
- 1 siteHaiti
- Study dates
- 9 Sep 2019to 19 Jan 2021
- Phase
- Observational
- 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 Up to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: The healthine service will be advertised to residents in or approximate to a 5Km radius centered around the healthline office, which is in the community of La Reserve, Gressier, Haiti. There are approximately 12,632 households in this area covering 79 sq km.
Who may be able to join
- age of patient must be 10 years or younger
- patient must reside inside the study delivery area
- consent/assent to participate
Who cannot join
- emergent illness (danger signs present)
Trial locations and contacts
1 site in 1 country.
Haiti1 site
University of Florida Public Health Research Laboratory
Gressier, Ouest
About this study
Official title: Novel Approach to Improve Patient Care and Diarrheal Disease Research Using Mobile Technology
Children in resource-limited settings who develop illness at night are often isolated from pre-emergency care, resulting in progression to an emergency because families are forced to wait until morning to seek care. This is especially true in Haiti based on needs assessments (INACT Part 1; INACT1) surrounding access to healthcare. This study (INACT Part 2; INACT2) seeks to improve access to care by establishing a health hotline (healthline) and mobile pharmacy for families with children who become ill at nighttime. The healthline will be staffed by medical professionals and will provide phone based assessment and treatment recommendations based on standard of care practices according to Haitian and WHO guidelines. The healthline will focus on pre-emergency patients (those without danger signs as defined by WHO guidelines). Emergent patients will be advised to bypass the healthline and seek immediate care at the nearest medical facility. In the event that a non-emergent patient requires access to basic medications or fluids and is logistically accessible, the mobile pharmacy service will be offered.
The specific aims of the study are as follows: Aim I. Evaluate congruence between healthline assessment over the phone and in-person assessment of participants (patients using the healthline) 10 years of age and younger. The investigators hypothesize that in-person assessments based on WHO guidelines will be discordant with those made by the healthline because the physical aspects of the call-center assessment will be performed by an untrained parent/ guardian. The study focuses on acute diarrheal disease (ADD) and acute respiratory illness (ARI) but is not exclusive to these two chief complaints. Aim II: Identify determinants that correlate with seeking care at a medical facility over the 8-12 day follow up period after the initial call. The findings from this study will determine if a healthline model is a safe and accurate method of providing high quality access to nighttime healthcare, averting the progression of non-emergent cases to emergencies.
- Being tested
- MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone
- Keywords
- Telemedicine, Diarrhea, Diarrhoea, mHealth, Healthline
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephoneOther
The healthline uses a series of questions (based off of the WHO Integrated Management of Childhood Illness guidelines) asked to the parent of a sick child over the phone to remotely triage and assess the child's illness and then provide a treatment recommendation. MotoMeds is the accompanying motorcycle delivery service for basic medication delivery at nighttime.
| Study group | Role | What they receive |
|---|---|---|
| Children living within study delivery area w/o danger signs | Families who call the healthline service about a sick child (no danger signs) and live within the mobile pharmacy delivery area will receive illness assessments and treatment recommendations over the phone. Immediately following calls a nurse will conduct household visits to complete in-person assessments of the children. Illness progression will be tracked with a 8-12 day follow up call. The phone and in-person assessments will be compared to evaluate safety and accuracy of the healthline. Receives: Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone | |
| Children living outside study delivery area w/o danger signs | Families who call the healthline service about a sick child (no danger signs) and live outside the delivery area will receive illness assessments and treatment recommendations over the phone. Illness progression will be tracked with a 8-12 day follow up call. Receives: Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone | |
| Children who are identified as having danger signs | Families who call the healthline service about a sick child and who are identified as having a danger sign will be directed to the nearest medical facility. Illness progression will be tracked with a 8-12 day follow up call. Receives: Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Congruence between phone and in person clinical assessment.
The responses parents give over the phone describing the child's illnesses will be compared to the routine clinical exam that the nurse performs in person. Clinical assessment features include vital signs, signs of work of breathings, and signs of dehydration per WHO and APP guidelines.
Measured: Begins when the healthline call is placed and ends once the nurse has completed the household visit; approximately 1-3 hours.
Secondary outcomes (1)
Determinants that correlate with seeking care at a medical facility
A follow up call will be placed 8-12 days after the initial healthline call to investigate factors associated with seeking care at a medical facility after the initial call to the heathline service.
Measured: Begins when the healthline call is placed and ends 8-12 days later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start9 Sep 2019
- Primary completion19 Jan 2021
- Study completion19 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute DiarrheaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Universite d'Etat d'Haiti
- Responsible party
- Sponsor
- Investigators
- Eric Nelson, MD PHD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943654
- Sponsor's protocol ID
- IRB201802920 -N
- Other IDs
- DP5OD019893
- Acronym
- INACT2
- Status last verified
- Jul 2022
- First submitted
- 7 May 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klarman MB, Chi X, Cajusma Y, Flaherty KE, Capois AC, Dofine MDV, Exantus L, Friesen J, Beau de Rochars VM, Becker T, Baril C, Gurka MJ, Nelson EJ. Development and evaluation of a clinical guideline for a paediatric telemedicine service in a low-resource setting. BMJ Paediatr Open. 2024 Jan 8;8(1):e002164. doi: 10.1136/bmjpo-2023-002164.
PubMed 38191203Klarman MB, Flaherty KE, Chi X, Cajusma Y, Capois AC, Vladimir Dofine MD, Exantus L, Friesen J, Beau de Rochars VM, Baril C, Gurka MJ, Becker TK, Nelson EJ. Implementation of a Pediatric Telemedicine and Medication Delivery Service in a Resource-limited Setting: A Pilot Study for Clinical Safety and Feasibility. J Pediatr. 2023 Jun;257:113304. doi: 10.1016/j.jpeds.2022.12.005. Epub 2022 Dec 14.
PubMed 36528053
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approach to Improve Patient Care and Diarrheal Disease Research Using Mobile Technology
- ClinicalTrials.gov ID
- NCT03943654
- Acronym / sponsor ID
- INACT2 / IRB201802920 -N
- Keywords
- Telemedicine, Diarrhea, Diarrhoea, mHealth, Healthline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Universite d'Etat d'Haiti
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 9 May 2019 (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.
Children in resource-limited settings who develop illness at night are often isolated from pre-emergency care, resulting in progression to an emergency because families are forced to wait until morning to seek care. This is especially true in Haiti based on needs assessments (INACT Part 1; INACT1) surrounding access to healthcare. This study (INACT Part 2; INACT2) seeks to improve access to care by establishing a health hotline (healthline) and mobile pharmacy for families with children who become ill at nighttime. The healthline will be staffed by medical professionals and will provide phone based assessment and treatment recommendations based on standard of care practices according to Haitian and WHO guidelines. The healthline will focus on pre-emergency patients (those without danger signs as defined by WHO guidelines). Emergent patients will be advised to bypass the healthline and seek immediate care at the nearest medical facility. In the event that a non-emergent patient requires access to basic medications or fluids and is logistically accessible, the mobile pharmacy service will be offered.
The specific aims of the study are as follows: Aim I. Evaluate congruence between healthline assessment over the phone and in-person assessment of participants (patients using the healthline) 10 years of age and younger. The investigators hypothesize that in-person assessments based on WHO guidelines will be discordant with those made by the healthline because the physical aspects of the call-center assessment will be performed by an untrained parent/ guardian. The study focuses on acute diarrheal disease (ADD) and acute respiratory illness (ARI) but is not exclusive to these two chief complaints. Aim II: Identify determinants that correlate with seeking care at a medical facility over the 8-12 day follow up period after the initial call. The findings from this study will determine if a healthline model is a safe and accurate method of providing high quality access to nighttime healthcare, averting the progression of non-emergent cases to emergencies.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children living within study delivery area w/o danger signs | – | Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephoneFamilies who call the healthline service about a sick child (no danger signs) and live within the mobile pharmacy delivery area will receive illness assessments and treatment recommendations over the phone. Immediately following calls a nurse will conduct household visits to complete in-person assessments of the children. Illness progression will be tracked with a 8-12 day follow up call. The phone and in-person assessments will be compared to evaluate safety and accuracy of the healthline. |
| Children living outside study delivery area w/o danger signs | – | Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephoneFamilies who call the healthline service about a sick child (no danger signs) and live outside the delivery area will receive illness assessments and treatment recommendations over the phone. Illness progression will be tracked with a 8-12 day follow up call. |
| Children who are identified as having danger signs | – | Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephoneFamilies who call the healthline service about a sick child and who are identified as having a danger sign will be directed to the nearest medical facility. Illness progression will be tracked with a 8-12 day follow up call. |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The healthine service will be advertised to residents in or approximate to a 5Km radius centered around the healthline office, which is in the community of La Reserve, Gressier, Haiti. There are approximately 12,632 households in this area covering 79 sq km.
Key inclusion criteria (3 listed)
- age of patient must be 10 years or younger
- patient must reside inside the study delivery area
- consent/assent to participate
Key exclusion criteria (1 listed)
- emergent illness (danger signs present)
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 |
|---|---|---|
| MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephoneThe healthline uses a series of questions (based off of the WHO Integrated Management of Childhood Illness guidelines) asked to the parent of a sick child over the phone to remotely triage and assess the child's illness and then provide a treatment recommendation. MotoMeds is the accompanying motorcycle delivery service for basic medication delivery at nighttime. | Other | Children living outside study delivery area w/o danger signs, Children living within study delivery area w/o danger signs, Children who are identified as having danger signs |
Primary outcome
Congruence between phone and in person clinical assessment.
Time frame: Begins when the healthline call is placed and ends once the nurse has completed the household visit; approximately 1-3 hours.
The responses parents give over the phone describing the child's illnesses will be compared to the routine clinical exam that the nurse performs in person. Clinical assessment features include vital signs, signs of work of breathings, and signs of dehydration per WHO and APP guidelines.
1 secondary outcome
Determinants that correlate with seeking care at a medical facility
Time frame: Begins when the healthline call is placed and ends 8-12 days later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 38191203Klarman MB, Chi X, Cajusma Y, Flaherty KE, Capois AC, Dofine MDV, Exantus L, Friesen J, Beau de Rochars VM, Becker T, Baril C, Gurka MJ, Nelson EJ. Development and evaluation of a clinical guideline for a paediatric telemedicine service in a low-resource setting. BMJ Paediatr Open. 2024 Jan 8;8(1):e002164. doi: 10.1136/bmjpo-2023-002164.
- Derived from this study: PubMed 36528053Klarman MB, Flaherty KE, Chi X, Cajusma Y, Capois AC, Vladimir Dofine MD, Exantus L, Friesen J, Beau de Rochars VM, Baril C, Gurka MJ, Becker TK, Nelson EJ. Implementation of a Pediatric Telemedicine and Medication Delivery Service in a Resource-limited Setting: A Pilot Study for Clinical Safety and Feasibility. J Pediatr. 2023 Jun;257:113304. doi: 10.1016/j.jpeds.2022.12.005. Epub 2022 Dec 14.
- Eric Nelson Research Program at UFLink provided by the sponsor.
- 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.
Eric Nelson, MD PHD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Diarrhea and Acute Respiratory Infection, run by University of Florida at 1 site in Haiti.
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: finished, as of the sponsor's last update on 20 Jul 2022. 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 Haiti. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Congruence between phone and in person clinical assessment. (time frame: Begins when the healthline call is placed and ends once the nurse has completed the household visit; approximately 1-3 hours.). 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 NCT03943654, which also lists 2 linked publications.
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 20 Jul 2022.