NCT03390023

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 14, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2018

Completed
Last Updated

November 12, 2019

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

December 26, 2017

Last Update Submit

November 7, 2019

Conditions

Keywords

Prenatal CareBarriersClinical Trials

Outcome Measures

Primary Outcomes (2)

  • Exploratory results from focus groups: access to and attitudes towards prenatal care

    Qualitative description of barriers to access in prenatal care

    1 year

  • Exploratory results from focus groups: access to and attitudes towards clinical trials

    Qualitative description of perceptions and beliefs regarding clinical trial research

    1 year

Study Arms (2)

Hispanic Women

Hispanic women who have been pregnant within the past 5 years.

Behavioral: Focus Group

Close Family Member

Close family member of participants in Group 1 - Hispanic Women.

Behavioral: Focus Group

Interventions

Focus GroupBEHAVIORAL

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 MemberHispanic Women

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Focus group participants will be identified both from community health fairs, community events and from local obstetrics and gynecology clinics.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Links

MeSH Terms

Interventions

Focus Groups

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Susan Carlson, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 4, 2018

Study Start

March 14, 2018

Primary Completion

May 10, 2018

Study Completion

May 10, 2018

Last Updated

November 12, 2019

Record last verified: 2019-11

Locations