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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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