Qualitative ResearchdeCiPHeRGapNCT04149236
A Qualitative Study of Cultural Perception of Health in Rural Guatemala
An observational study of Qualitative Research and Beliefs, run by University of Colorado, Denver.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Qualitative Research, Beliefs
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 11 Aug 2023
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- < 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
About this study
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.
Read the 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.
- Conditions
- Qualitative Research, Beliefs
- Keywords
- Culture
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Aug 2019
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Why it stopped: Was halted during the COVID pandemic; study continuation plans discontinued as some investigators no longer associated with the University of Colorado.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Qualitative ResearchStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James L Martin, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149236
- Sponsor's protocol ID
- 19-1828
- Acronym
- deCiPHeRGap
- Status last verified
- Aug 2023
- First submitted
- 29 Oct 2019
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study of Cultural Perception of Health in Rural Guatemala
- ClinicalTrials.gov ID
- NCT04149236
- Acronym / sponsor ID
- deCiPHeRGap / 19-1828
- Conditions
- Qualitative Research, Beliefs
- Keywords
- Culture
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Was halted during the COVID pandemic; study continuation plans discontinued as some investigators no longer associated with the University of Colorado.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 4 Nov 2019 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: No. 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.
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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.
James L Martin principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
An observational study of Qualitative Research and Beliefs, run by University of Colorado, Denver.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Prevalence of Gaps in Knowledge Surrounding Health Services (time frame: Day 1). The study lists 2 primary outcomes in all. 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 Aug 2023.