- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04149236
A Qualitative Study of Cultural Perception of Health in Rural Guatemala (deCiPHeRGap)
August 14, 2023 updated by: University of Colorado, Denver
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.
Study Overview
Status
Withdrawn
Conditions
Detailed 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.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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 64 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
The study population will consist of local rural Guatemalans that live within 50 km of the clinic site that wish to participate in completing a questionnaire to better inform the clinic of community needs, educational opportunities, and available resources.
Description
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 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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of Gaps in Knowledge Surrounding Health Services
Time Frame: Day 1
|
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
|
|
Perceptions of Healthcare, as Determined by Agreeability of Statements
Time Frame: Day 1
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James L Martin, University of Colorado, Denver
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)
August 1, 2019
Primary Completion (Actual)
August 11, 2023
Study Completion (Actual)
August 11, 2023
Study Registration Dates
First Submitted
October 29, 2019
First Submitted That Met QC Criteria
October 31, 2019
First Posted (Actual)
November 4, 2019
Study Record Updates
Last Update Posted (Actual)
August 18, 2023
Last Update Submitted That Met QC Criteria
August 14, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19-1828
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The Investigators will de-identify participants and pool total data after questionnaire completion.
The results of pooled data may be shared but individual participant data will not be.
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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