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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04149236
Other study ID # 19-1828
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date August 11, 2023

Study information

Verified date August 2023
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Investigators will be giving a survey to ~100 people in a rural community in Guatemala to discover beliefs and perspectives that the Participants have surrounding various aspects of healthcare. The Investigators aim to do this in order to be able to better serve the population in the community by discovering specific information about them from the Participants and how the Participants about different health practices. The Investigators will answer their research questions through the questionnaire that will allow participants to explain their viewpoints about a variety of medical topics.


Description:

The design of this cross-sectional study is centered around a structured questionnaire of a mixed qualitative and quantitative nature that is composed primarily of yes/no or Likert scale responses. All questions are written with the intent that they may be understood by those participants without any formal education. The investigators will recruit participants that are currently using the services of the Trifinio clinic in rural Guatemala as these are likely to fit inclusion criteria and will be able to benefit from potential future services that will be directed by the findings of this questionnaire. For all participants, Likert scale questions will be used with a series of faces to help indicate meanings for the answers and to decrease possibility of misinterpretation. Participants will be recruited through non-probabilistic sampling and the use of snowball sampling. Screening of these participants for exclusion criteria will be performed before questionnaires are distributed. The questions of the questionnaire are designed to elicit information about certain beliefs or preferences related to healthcare in a structured manner that allows us to compare answers and determine trends, prevalence, and associations that are likely to exist among community members. Participation will be completely voluntary and informed consent will be obtained from each participant before they are given the questionnaire. For participants who are illiterate or would prefer to have the informed consent and questionnaire read aloud to them, this will be done by one of the CITI-trained investigators. Recorded data will only include questionnaire responses and will not include any identifying information. We will be using randomized numbers in order to refer to completed questionnaires, but these numbers will have no identifying aspects and will be used for the sole purpose of keeping track of the gathered data. The information gathered will be de-identified and stored and password-protected through REDCap.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 11, 2023
Est. primary completion date August 11, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - Age 18-64 - Willing and able to participate in the questionnaire (if participant is illiterate, they will have the option to have each question and all responses read to them aloud by one of the trained researchers) - Live in one of the communities within 50 km of the research site - Those participants born in Guatemala Exclusion Criteria: - < 18 or >64 years old - Decisionally challenged - Refusal or inability to give consent - Those born outside of Guatemala - Those living in areas > 50 km from the research site

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of Gaps in Knowledge Surrounding Health Services A survey with yes/no questions whether a participant is aware of health services available to them. Answers will be scored as 1 = Yes/Aware or 0=No/Not Aware. Day 1
Primary Perceptions of Healthcare, as Determined by Agreeability of Statements Likert scale responses will be shown to participants who will choose among 5 answers ranging from "Very Much So Disagree" to "Very Much So Agree". The answers chosen will be summed and put into percentages that each answer receives, demonstrating prevalence of those beliefs among the participants. Day 1
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