- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04409535
Effects of the COVID-19 Health Emergency on Biopsychosocial Health
October 15, 2024 updated by: Carla S. Wilhite, University of New Mexico
Effects of the COVID-19 Health Emergency on the Biopsychosocial Health of Rural Residents of New Mexico Using Mixed Methods Research
There is a critical need to determine the impact of the COVID-19 emergency on the comprehensive well-being of people as they are living through the emergency and sequelae of the emergency period.
The research team is requesting National Institutes of Health funding with the goal to investigate rural vs. urban living people's response to the crisis and its impact using mixed methods research.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The state of New Mexico and the entire nation have entered an unprecedented health emergency created by the COVID-19 virus; affecting the lives of all people, many of whom were significantly unprepared for the disruptions the emergency created in daily life.
Rural residents are at increased risk from effects of the emergency due to numerous disadvantages as compared to urban living people (i.e.
critical care access, food insecurity, social isolation).
Very little is known about how people are living through a national emergency event affecting all people of the nation.
Therefore, a significant gap in knowledge exists: 1.
How are rural-living vs. urban-living people responding physically and mentally to the crisis?
2. What strategies of resilience are employed by people living in rural vs. urban counties?
3. What are perceptions of access to critical supplies and services in urban vs. rural counties; 4. How is the availability and use of technology used for news, reliable information, and communication? and 5. Use of time: what alterations in daily life self-care, care of others, commerce, and valued routines in urban vs. rural counties are occurring?
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- University of New Mexico Department of Pediatrics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Urban or rural living residents of New Mexico currently living under the "stay at home" emergency secondary to COVID-19
Description
Inclusion Criteria:
- Urban and rural living residents of New Mexico, any gender, gender identity, any ethnic origin, any health status (healthy, chronic, disabled), and adult age from 18-85
Exclusion Criteria:
- Non-New Mexico residents, adults unable to give consent due to cognition or incarceration status
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Rural Living Community Member
Adult residents of a New Mexico rural county (as federally designated)
|
Participants will be surveyed and interviewed about their perceptions regarding COVID-19 health emergency
Other Names:
|
|
Urban/Suburban Living Community Member
Comparison group: adult resident of a New Mexico urban/suburban city or town (as federally designated)
|
Participants will be surveyed and interviewed about their perceptions regarding COVID-19 health emergency
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
World Health Organization Quality of Life-Brief Scale
Time Frame: From enrollment until post-event (Feb. 2021)
|
participant responses about quality of life during COVID-19 emergency
|
From enrollment until post-event (Feb. 2021)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Open-ended Interview
Time Frame: From enrollment until post-event (Feb. 2021)
|
Participants responses to open-ended interview questions regarding alteration in daily life routines
|
From enrollment until post-event (Feb. 2021)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carla Wilhite, DOT, University of New Mexico
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2020
Primary Completion (Actual)
November 1, 2021
Study Completion (Actual)
November 1, 2021
Study Registration Dates
First Submitted
May 11, 2020
First Submitted That Met QC Criteria
May 28, 2020
First Posted (Actual)
June 1, 2020
Study Record Updates
Last Update Posted (Actual)
October 18, 2024
Last Update Submitted That Met QC Criteria
October 15, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-266
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified, aggregated data will be available
IPD Sharing Time Frame
March 2021 (tentative) and will be available for three years
IPD Sharing Access Criteria
Written request from other academic research university
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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