ActivitiesNCT04409535
Effects of the COVID-19 Health Emergency on Biopsychosocial Health
An observational study of Activities and Mental Health Issue, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Activities, Mental Health Issue, Life Style
- What is being tested?
- WHOQOL-BREF survey
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2020to 1 Nov 2021
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Urban or rural living residents of New Mexico currently living under the "stay at home" emergency secondary to COVID-19
Who may be able to join
- 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
Who cannot join
- Non-New Mexico residents, adults unable to give consent due to cognition or incarceration status
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Department of Pediatrics
Albuquerque, New Mexico, 87131
About this study
Official title: 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.
Read the 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?
- Conditions
- Activities, Mental Health Issue, Life Style
- Being tested
- WHOQOL-BREF survey
- Keywords
- Quality of Life, Rural Community, COVID-19
- Medical subject headings
- Motor Activity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHOQOL-BREF surveyOther
Also called Personal Interview
Participants will be surveyed and interviewed about their perceptions regarding COVID-19 health emergency
| Study group | Role | What they receive |
|---|---|---|
| Rural Living Community Member | Adult residents of a New Mexico rural county (as federally designated) Receives: Other: WHOQOL-BREF survey | |
| Urban/Suburban Living Community Member | Comparison group: adult resident of a New Mexico urban/suburban city or town (as federally designated) Receives: Other: WHOQOL-BREF survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life-Brief Scale
participant responses about quality of life during COVID-19 emergency
Measured: From enrollment until post-event (Feb. 2021)
Secondary outcomes (1)
Open-ended Interview
Participants responses to open-ended interview questions regarding alteration in daily life routines
Measured: From enrollment until post-event (Feb. 2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start7 May 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ActivitiesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla S. Wilhite, University of New Mexico
- Investigators
- Carla Wilhite, DOT, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409535
- Sponsor's protocol ID
- 20-266
- Status last verified
- Oct 2024
- First submitted
- 11 May 2020
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, aggregated data will be available
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the COVID-19 Health Emergency on the Biopsychosocial Health of Rural Residents of New Mexico Using Mixed Methods Research
- ClinicalTrials.gov ID
- NCT04409535
- Acronym / sponsor ID
- 20-266
- Conditions
- Activities, Mental Health Issue, Life Style
- Keywords
- Quality of Life, Rural Community, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 7 May 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 1 Jun 2020 (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.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rural Living Community Member | – | Other: WHOQOL-BREF surveyAdult residents of a New Mexico rural county (as federally designated) |
| Urban/Suburban Living Community Member | – | Other: WHOQOL-BREF surveyComparison group: adult resident of a New Mexico urban/suburban city or town (as federally designated) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Urban or rural living residents of New Mexico currently living under the "stay at home" emergency secondary to COVID-19
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Non-New Mexico residents, adults unable to give consent due to cognition or incarceration status
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 |
|---|---|---|
| WHOQOL-BREF surveyAlso: Personal InterviewParticipants will be surveyed and interviewed about their perceptions regarding COVID-19 health emergency | Other | Rural Living Community Member, Urban/Suburban Living Community Member |
Primary outcome
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
1 secondary outcome
Open-ended Interview
Time frame: From enrollment until post-event (Feb. 2021)
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 18 Oct 2024.
- Individual participant dataSharing planned: Yes. De-identified, aggregated data will be available
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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.
Carla Wilhite, DOT principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Activities and Mental Health Issue, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 18 Oct 2024. 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 United States. 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?
World Health Organization Quality of Life-Brief Scale (time frame: From enrollment until post-event (Feb. 2021)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2024.