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Finding Opportunities for Clinical Care and Trial Participation Among Underrepresented Samples (ADORE FOCUS)

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ClinicalTrials.gov Identifier: NCT03390023
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : April 26, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
Focus groups for Hispanic women who are pregnant and their close family members to assess attitudes, barriers and cultural beliefs involved in participation in clinical trials

Condition or disease Intervention/treatment
Pregnancy Related Behavioral: Focus Group

Detailed Description:
This is a qualitative study conducted with Hispanic pregnant women and their families. Focus groups for Hispanic pregnant women will run concurrent to groups for their close family member, but in separate rooms. Each focus group session of approximately 8-10 participants is expected to last 60-90 minutes and will be led by an experienced moderator who is fluent in Spanish. All discussions will be audio taped and will be kept confidential. Information learned will be used to refine clinical trial procedures and ensure our model of recruitment and retention in the parent ADORE Trial (NCT02626299) is culturally and linguistically acceptable and feasible.

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Finding Opportunities for Clinical Care and Trial Participation Among Underrepresented Samples: An Administrative Supplement to the ADORE Trial
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : January 15, 2019

Group/Cohort Intervention/treatment
Hispanic Women
Hispanic women who have been pregnant within the past 5 years.
Behavioral: Focus Group
Groups will last 60 to 90 minutes. Focus groups will be moderated by KUMC Juntos staff who are formally trained to conduct focus groups. General topics to be covered in focus groups include: attitudes, preferences and knowledge about prenatal care, clinical trial participation, and nutritional supplement use. Focus groups will be conducted in Spanish.

Close Family Member
Close family member of participants in Group 1 - Hispanic Women.
Behavioral: Focus Group
Groups will last 60 to 90 minutes. Focus groups will be moderated by KUMC Juntos staff who are formally trained to conduct focus groups. General topics to be covered in focus groups include: attitudes, preferences and knowledge about prenatal care, clinical trial participation, and nutritional supplement use. Focus groups will be conducted in Spanish.




Primary Outcome Measures :
  1. Exploratory results from focus groups: access to and attitudes towards prenatal care [ Time Frame: 1 year ]
    Qualitative description of barriers to access in prenatal care

  2. Exploratory results from focus groups: access to and attitudes towards clinical trials [ Time Frame: 1 year ]
    Qualitative description of perceptions and beliefs regarding clinical trial research



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Focus group participants will be identified both from community health fairs, community events and from local obstetrics and gynecology clinics.
Criteria

Inclusion Criteria:

  • Hispanic women between the ages of 18.0-49.99 yrs old who have been pregnant within the past 5 years OR a close family member
  • Speak and understand Spanish

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390023


Contacts
Contact: Beth Kerling, MS, RD, CCRP (913) 588-5743 ekerling@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Susan Carlson, PhD University of Kansas Medical Center

Additional Information:
Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03390023     History of Changes
Other Study ID Numbers: STUDY00141699
3R01HD083292-02S1 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas Medical Center:
Prenatal Care
Barriers
Clinical Trials