Home-based Care and Hand Hygiene Interventions in Honduras
NCT04886414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1821
Last updated 2025-05-14
Summary
This study aims to enroll patients with acute infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) who do not meet criteria for hospital admission according to protocols developed by the Honduras Ministry of Health (MOH). Patients who are triaged to home must also be over the age of 60 years or have one high risk comorbidity and be over 45 years in order to meet inclusion criteria. These patients will be randomly assigned to one of four home-based care strategies, which may or may not include regular blood oxygenation monitoring and provision of alcohol-based hand-rub. Patients will be followed until resolution of their acute illness, and data will be collected on feasibility, impact and acceptance of the intervention. Some patients will be followed for up to one year to monitor for post-Coronavirus Disease 2019 (COVID-19) symptoms.
Conditions
- Covid19
Interventions
- OTHER
-
Phone-based monitoring
Study staff will perform daily phone-based assessments using standardized electronic study tools (tablets). Clinical features will be documented on a phone-based patient monitoring form.
- OTHER
-
Oxygen saturation monitoring
Oxygen saturation will be monitored and recorded at regular intervals.
- OTHER
-
Alcohol-based hand sanitizer
Alcohol-based hand sanitizer will be distributed to subjects.
Sponsors & Collaborators
-
Centers for Disease Control and Prevention
collaborator FED -
Ministry of Health, Honduras
collaborator OTHER_GOV -
Brigham and Women's Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-31
- Primary Completion
- 2023-01-15
- Completion
- 2023-02-28
Countries
- Honduras
Study Locations
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