Finding Opportunities for Clinical Care and Trial Participation Among Underrepresented Samples

Pregnancy Related Clinical Trial

— ADORE FOCUS  

Official title:

Finding Opportunities for Clinical Care and Trial Participation Among Underrepresented Samples: An Administrative Supplement to the ADORE Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390023
• Other study ID #: STUDY00141699
• Secondary ID: 3R01HD083292-02S
• Status: Completed
• Start date: March 14, 2018
• Est. completion date: May 10, 2018

Study information

• Verified date: November 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 10, 2018
• Est. primary completion date: May 10, 2018
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exploratory results from focus groups: access to and attitudes towards prenatal care	Qualitative description of barriers to access in prenatal care	1 year
Primary	Exploratory results from focus groups: access to and attitudes towards clinical trials	Qualitative description of perceptions and beliefs regarding clinical trial research	1 year

External Links

•   Main Study Clinicaltrials.gov Record: Assessment of DHA On Reducing Early Preterm Birth (ADORE)