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Effects of the COVID-19 Health Emergency on Biopsychosocial Health

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ClinicalTrials.gov Identifier: NCT04409535
Recruitment Status : Active, not recruiting
First Posted : June 1, 2020
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Carla S. Wilhite, University of New Mexico

Brief Summary:
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.

Condition or disease Intervention/treatment
Activities Mental Health Issue Life Style Other: WHOQOL-BREF survey

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?

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Ecologic or Community
Time Perspective: Other
Official Title: Effects of the COVID-19 Health Emergency on the Biopsychosocial Health of Rural Residents of New Mexico Using Mixed Methods Research
Actual Study Start Date : May 7, 2020
Estimated Primary Completion Date : February 25, 2021
Estimated Study Completion Date : March 31, 2021

Group/Cohort Intervention/treatment
Rural Living Community Member
Adult residents of a New Mexico rural county (as federally designated)
Other: WHOQOL-BREF survey
Participants will be surveyed and interviewed about their perceptions regarding COVID-19 health emergency
Other Name: Personal Interview

Urban/Suburban Living Community Member
Comparison group: adult resident of a New Mexico urban/suburban city or town (as federally designated)
Other: WHOQOL-BREF survey
Participants will be surveyed and interviewed about their perceptions regarding COVID-19 health emergency
Other Name: Personal Interview




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409535


Locations
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United States, New Mexico
University of New Mexico Department of Pediatrics
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Carla Wilhite, DOT University of New Mexico
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Responsible Party: Carla S. Wilhite, Assistant Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT04409535    
Other Study ID Numbers: 20-266
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified, aggregated data will be available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: March 2021 (tentative) and will be available for three years
Access Criteria: Written request from other academic research university

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carla S. Wilhite, University of New Mexico:
Quality of Life
Rural Community
COVID-19
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes