Pediatric ALLINACT2-GNCT05506683
Improving Nighttime Access to Care and Treatment; Part 2- Ghana
A study testing MotoMeds pediatric telemedicine and medication delivery service (TMDS) in people with Pediatric ALL and Acute Disease, run by University of Florida at 1 site in Ghana.
Trial summary
Globally, leading causes of death among children one month to 5 years old are pneumonia, diarrheal disease and malaria which are treatable early in the disease-course with low-cost medications. However, these diseases can progress to emergencies when access to care is delayed. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Pediatric ALL, Acute Disease
- What is being tested?
- MotoMeds pediatric telemedicine and medication delivery service (TMDS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,239 participants
- Where
- 1 siteGhana
- Study dates
- 16 Nov 2022to 1 Jul 2025
- 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 Up to 10 years
- All sexes
- No healthy volunteers
- Child
Child Participant Inclusion Criteria:
- Child ≤ 10 years
- Has an acute medical problem
- Provides written assent (if 10 years and receives a household visit)
Child Participant Exclusion Criteria:
- Child > 10 years
- Child does not have an acute medical problem
- Medical problem involves physical trauma or mental health
- Refusal of written assent (if 10 years and receives a household visit)
Parent/Guardian Participant Inclusion Criteria:
- Calls MotoMeds during operating hours
- Parent/guardian of a patient participant meeting inclusion criteria
- Adult (18 years or older)
- Provides written consent (household visit) or a waiver of documentation of consent (no household visit)
Parent/Guardian Participant Exclusion Criteria:
- Age < 18 years
- No written consent or waiver of documentation of consent
- Corresponding child does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
Ghana1 site
National Ambulance Service
Accra, Accra Metropolitan District, GA-143-8975
About this study
Official title: Pilot Implementation of a Nighttime Telemedicine and Medication Delivery Service to Increase Access to Pre-emergency Pediatric Care in Ghana
Globally, leading causes of death among children one month to 5 years old are pneumonia, diarrheal disease and malaria which are treatable early in the disease-course with low-cost medications. However, these diseases can progress to emergencies when access to care is delayed. In response, a telemedicine and medication delivery service (TMDS) was designed to improve nighttime access to pediatric care and treatment. The TMDS will be implemented in three distinct Ghanaian community to evaluate the clinical safety, operational feasibility of implementing,and scalability of the service.
Read the detailed description
Globally, leading causes of death among children one month to 5 years old are pneumonia, diarrheal disease and malaria which are treatable early in the disease-course with low-cost medications. However, these diseases can progress to emergencies when access to care is delayed. In response, a telemedicine and medication delivery service (TMDS) called MotoMeds was designed to overcome barriers to seeking care. MotoMeds targets the nighttime period when barriers to accessing care are highest. The TMDS was initially deployed in Haiti and will now be evaluated for generalizability and portability in Ghana.
The study objectives are to assess clinical safety and logistical feasibility of the TMDS. The study population is children in Accra and Tamale. The workflow consists of parents/guardians calling the TMDS on their child's behalf, Emergency Medical Technicians (EMTs) referring severe cases to emergency services, EMTs performing a phone assessment for non-severe cases, and EMTs traveling to the child's household to perform an in-person exam, rapid diagnostic testing for malaria where indicated as per protocol, and to deliver protocolized medications for cases within a predefined delivery zone.
EMTs and the protocols/guidelines used are supervised by Ghanaian and US physicians.
Clinical safety and feasibility of the TMDS will be evaluated using patient and logistical metrics.
- Conditions
- Pediatric ALL, Acute Disease
- Being tested
- MotoMeds pediatric telemedicine and medication delivery service (TMDS)
- Keywords
- Telemedicine, Healthcare Access, Nighttime
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotoMeds pediatric telemedicine and medication delivery service (TMDS)Other
The intervention is use of a pediatric TMDS. Eligible children experiencing acute illness are examined over the phone by EMTs who follow a set of clinical guidelines to triage, assess, and develop treatment plans for participants. To evaluate the TMDS and as a safety measure EMTs will also examine most participants in-person a their homes following the phone exam.
| Study group | Role | What they receive |
|---|---|---|
| MotoMeds users (parent/chid participant pairs) | Experimental | Not described Receives: Other: MotoMeds pediatric telemedicine and medication delivery service (TMDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of guideline adherence at the call center.
Establish the rates of provider adherence to the TMDS clinical guidelines while performing assessments and generating treatment plans at the call center. Points of non-adherence will include severity assessments, missed danger signs and non-indicated or missed antibiotic prescriptions.
Measured: 1 day
Secondary outcomes (3)
The rate of guideline adherence at the household.
Establish the rates of provider adherence to the TMDS clinical guidelines while performing assessments and generating treatment plans at the household. Points of non-adherence will include severity assessments, missed danger signs and non-indicated or missed antibiotic prescriptions.
Measured: 1 day
Sensitivity, specificity and congruence of clinical variables
Determine sensitivity and specificity of each clinical variable at the call center using the in-person exam at the household as the reference standard. Establish congruence between call center and in-person assessment in terms of severity categorization, danger signs, disease type, and treatment plans.
Measured: 1 day
Participant clinical status at 8-12 days
Determine the clinical status of participants 8-12 days following their initial contact with the TMDS. Participant families will report the status (recovered, better, same, worse, died) to TMDS staff during a follow-up phone call.
Measured: Between 8-12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start16 Nov 2022
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,239 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Ghana National Ambulance Service
- Responsible party
- Sponsor
- Investigators
- Torben K Becker, MD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506683
- Sponsor's protocol ID
- IRB202201648
- Acronym
- INACT2-G
- Status last verified
- Sep 2024
- First submitted
- 17 Aug 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified individual participant data (IDP) will be made publicly available through a data depository such as Dryad.
Publications
Flaherty KE, Klarman MB, Cajusma Y, Schon J, Exantus L, Beau de Rochars VM, Baril C, Becker TK, Nelson EJ. A Nighttime Telemedicine and Medication Delivery Service to Avert Pediatric Emergencies in Haiti: An Exploratory Cost-Effectiveness Analysis. Am J Trop Med Hyg. 2022 Feb 21;106(4):1063-1071. doi: 10.4269/ajtmh.21-1068. Print 2022 Apr 6.
PubMed 35189597Flaherty KE, Zakariah AN, Vescio VA, Osei-Ampofo M, Mahama MN, Agongo V, Becker TK. The state of emergency medical technician education in Ghana. Afr J Emerg Med. 2020 Sep;10(3):107-110. doi: 10.1016/j.afjem.2020.01.009. Epub 2020 Mar 7.
PubMed 32923318Flaherty KE, Mahama MN, Klarman MB, Anane-Binfoh NA, Patel MD, Smith NJ, Osei-Ampofo M, Mathelier M, Nelson EJ, Zakariah AN, Afaa TJ, Becker TK. Applying the ADAPT guidance to implement a telemedicine and medication delivery service in a malaria-endemic setting: A prospective cohort study. Trop Med Int Health. 2025 Mar;30(3):181-192. doi: 10.1111/tmi.14081. Epub 2025 Jan 16.
PubMed 39815954
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Implementation of a Nighttime Telemedicine and Medication Delivery Service to Increase Access to Pre-emergency Pediatric Care in Ghana
- ClinicalTrials.gov ID
- NCT05506683
- Acronym / sponsor ID
- INACT2-G / IRB202201648
- Conditions
- Pediatric ALL, Acute Disease
- Keywords
- Telemedicine, Healthcare Access, Nighttime
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,239 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Ghana National Ambulance Service
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 18 Aug 2022 (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.
Globally, leading causes of death among children one month to 5 years old are pneumonia, diarrheal disease and malaria which are treatable early in the disease-course with low-cost medications. However, these diseases can progress to emergencies when access to care is delayed. In response, a telemedicine and medication delivery service (TMDS) was designed to improve nighttime access to pediatric care and treatment. The TMDS will be implemented in three distinct Ghanaian community to evaluate the clinical safety, operational feasibility of implementing,and scalability of the service.
Detailed description
Globally, leading causes of death among children one month to 5 years old are pneumonia, diarrheal disease and malaria which are treatable early in the disease-course with low-cost medications. However, these diseases can progress to emergencies when access to care is delayed. In response, a telemedicine and medication delivery service (TMDS) called MotoMeds was designed to overcome barriers to seeking care. MotoMeds targets the nighttime period when barriers to accessing care are highest. The TMDS was initially deployed in Haiti and will now be evaluated for generalizability and portability in Ghana.
The study objectives are to assess clinical safety and logistical feasibility of the TMDS. The study population is children in Accra and Tamale. The workflow consists of parents/guardians calling the TMDS on their child's behalf, Emergency Medical Technicians (EMTs) referring severe cases to emergency services, EMTs performing a phone assessment for non-severe cases, and EMTs traveling to the child's household to perform an in-person exam, rapid diagnostic testing for malaria where indicated as per protocol, and to deliver protocolized medications for cases within a predefined delivery zone.
EMTs and the protocols/guidelines used are supervised by Ghanaian and US physicians.
Clinical safety and feasibility of the TMDS will be evaluated using patient and logistical metrics.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MotoMeds users (parent/chid participant pairs) | Experimental | Other: MotoMeds pediatric telemedicine and medication delivery service (TMDS) |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 pediatric telemedicine and medication delivery service (TMDS)The intervention is use of a pediatric TMDS. Eligible children experiencing acute illness are examined over the phone by EMTs who follow a set of clinical guidelines to triage, assess, and develop treatment plans for participants. To evaluate the TMDS and as a safety measure EMTs will also examine most participants in-person a their homes following the phone exam. | Other | MotoMeds users (parent/chid participant pairs) |
Primary outcome
The rate of guideline adherence at the call center.
Time frame: 1 day
Establish the rates of provider adherence to the TMDS clinical guidelines while performing assessments and generating treatment plans at the call center. Points of non-adherence will include severity assessments, missed danger signs and non-indicated or missed antibiotic prescriptions.
3 secondary outcomes
The rate of guideline adherence at the household.
Time frame: 1 day
Sensitivity, specificity and congruence of clinical variables
Time frame: 1 day
Participant clinical status at 8-12 days
Time frame: Between 8-12 days
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 25 Sep 2025.
- Background: PubMed 35189597Flaherty KE, Klarman MB, Cajusma Y, Schon J, Exantus L, Beau de Rochars VM, Baril C, Becker TK, Nelson EJ. A Nighttime Telemedicine and Medication Delivery Service to Avert Pediatric Emergencies in Haiti: An Exploratory Cost-Effectiveness Analysis. Am J Trop Med Hyg. 2022 Feb 21;106(4):1063-1071. doi: 10.4269/ajtmh.21-1068. Print 2022 Apr 6.
- Background: PubMed 32923318Flaherty KE, Zakariah AN, Vescio VA, Osei-Ampofo M, Mahama MN, Agongo V, Becker TK. The state of emergency medical technician education in Ghana. Afr J Emerg Med. 2020 Sep;10(3):107-110. doi: 10.1016/j.afjem.2020.01.009. Epub 2020 Mar 7.
- Derived from this study: PubMed 39815954Flaherty KE, Mahama MN, Klarman MB, Anane-Binfoh NA, Patel MD, Smith NJ, Osei-Ampofo M, Mathelier M, Nelson EJ, Zakariah AN, Afaa TJ, Becker TK. Applying the ADAPT guidance to implement a telemedicine and medication delivery service in a malaria-endemic setting: A prospective cohort study. Trop Med Int Health. 2025 Mar;30(3):181-192. doi: 10.1111/tmi.14081. Epub 2025 Jan 16.
- MotoMeds websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The de-identified individual participant data (IDP) will be made publicly available through a data depository such as Dryad.
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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.
Torben K Becker, 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?
A study testing MotoMeds pediatric telemedicine and medication delivery service (TMDS) in people with Pediatric ALL and Acute Disease, run by University of Florida at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Sep 2025. 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 Ghana. 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?
The rate of guideline adherence at the call center. (time frame: 1 day). 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 NCT05506683, which also lists 3 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 25 Sep 2025.