Improving Nighttime Access to Care & Treatment; Part 4-Haiti

Status Recruiting

Clinical Trial Summary

Children in resource-limited settings who develop illness at night are often isolated from care, resulting in progression to an emergency. A telemedicine and medication delivery service (TMDS) is a viable healthcare delivery option to bridge the gap in nighttime care. This interrupted time series study (pre/post) will evaluate a digital clinical decision-support (dCDS) tool. The objective is to assess if the tool is associated with an improvement in guideline adherence by TMDS providers.

Clinical Trial Description

Acute respiratory infection and diarrheal disease are the two leading causes of pediatric death between 1 month and 5 years of age globally. These common problems have well-established low-cost treatments. However, these treatments are most effective when administered early which is difficult in resource-limited settings, especially at night. Based on five years of formative NIH-funded research, the team has built a Telemedicine and Medication Delivery Service (TMDS) in Haiti to improve nighttime access to care and treatment for children called MotoMeds. The strategic plan is to design, deploy and evaluate MotoMeds by conducting four clinical studies titled Improving Nighttime Access to Care and Treatment (INACT1/2/3/4) in Haiti. INACT1-H was a needs assessment (2018-2019), INACT2-H was a pre-pilot deployment of MotoMeds that compared the congruence of clinical assessments at the call-center to in-person household assessments by providers (2019-2020), and INACT3-H was a pilot of a scalable model of MotoMeds that had provider assessment only at the call-center for most non-severe cases and had provider assessment at both the call-center and household for some non-severe/ moderate cases. In addition, the central call center serviced a geographically distant delivery zone, demonstrating proof of concept for a fully scaled model. INACT4-H will evaluate a digital clinical decision support (dCDS) tool designed for use at a pediatric TMDS in an interrupted time series study. The pre-intervention is use of the existing paper CDS tool and the intervention is use of the dCDS tool. This initiative is significant because it uses telemedicine and medication delivery to address one of the most fundamental challenges in pediatrics early access to pediatric healthcare. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05480930
Study type	Interventional
Source	University of Florida
Contact	Molly B Klarman, MPH
Phone	509 4600-7486
Email	mklarman@ufl.edu
Status	Recruiting
Phase	N/A
Start date	September 27, 2022
Completion date	June 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03574480` - Smartphone Applications to Improve Lifestyles in Olders Over 65 Years	N/A
Not yet recruiting	`NCT04070066` - Educational Strategy IN Exchange Transfusion	N/A
Active, not recruiting	`NCT05043220` - Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Systemic Cancer Therapy	N/A
Recruiting	`NCT04045054` - Home-based Transitional Telecare for Older Veterans	N/A
Completed	`NCT04652674` - Impact of Postoperative Telemedicine Visit vs In-person Visit on Patient Satisfaction During the COVID-19 Pandemic	N/A
Completed	`NCT03295474` - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Completed	`NCT02196428` - Medical Telemonitoring Plus Individual Teleconsultation in Elderly	N/A
Completed	`NCT03025217` - Total Lifestyle Coaching Pilot Study (TLC)	N/A
Completed	`NCT01820234` - Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event	N/A
Recruiting	`NCT04392518` - Telerehabilitation in Proximal Muscle Weakness	N/A
Completed	`NCT05147038` - The Impact of Tele-coaching on the Physical Activity Level	N/A
Not yet recruiting	`NCT05897710` - Virtual World-Based Cardiac Rehabilitation	N/A
Not yet recruiting	`NCT06466837` - Just-In-Time Adaptive Interventions for Diabetic Patients	N/A
Not yet recruiting	`NCT04444297` - 3D Telemedicine During COVID-19: Non-clinical Validation	N/A
Not yet recruiting	`NCT04513496` - Telemedicine in HIV Care in Buenos Aires
Completed	`NCT05895539` - Evaluating Treatment Continuation in Telehealth Patients Receiving an Automated Patient-Reported Outcome Tool	N/A
Active, not recruiting	`NCT03474692` - Virta Health Registry
Recruiting	`NCT05046392` - mHealth Facilitated Intervention to Improve Medication Adherence Among Persons Living With HIV	N/A
Recruiting	`NCT05231018` - A Study on a Digital Platform for COVID19+ Patients, Designed to Facilitate Communication and Mental-health Care During and After Hospitalization.	N/A
Recruiting	`NCT05617560` - Hospital@Home: Telemedical Care After Inpatient Hospital Stay	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Improving Nighttime Access to Care and Treatment; Part 4-Haiti — INACT4-H

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms