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Feasibility of Remote Data Collection With a Point of Care Device to Measure HbA1c

Sponsor
Washington University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05725746
Collaborator
(none)
15
Enrollment
4.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Conduct a pilot study to test feasibility of doing remote data collection with a point of care device that measures HbA1c.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Point of care device to measure HbA1c

Detailed Description

The foundation for cardiovascular health (CVH) is laid in early life by intergenerational interactions, passed from parent to child, that have long-lasting biological and behavioral consequences. Lifestyle interventions can promote CVH among mothers and their children over time. Academic partnerships with home visiting organizations that reach families experiencing health disparities advance intergenerational CVH equity. For this pilot study we are testing the feasibility of doing remote data collection with a point of care device that measures HbA1c to use in the main study.

Study Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Enhancing Cardiovascular Health Equity in Mothers and Children Through Home Visiting
Anticipated Study Start Date :
Feb 6, 2023
Anticipated Primary Completion Date :
Jun 12, 2023
Anticipated Study Completion Date :
Jun 12, 2023

Outcome Measures

Primary Outcome Measures

  1. Feasibility to obtain HbA1c through remote data collection [Baseline]

    Feasibility will be measured by how many participants are able to obtain HbA1c measure through remote data collection and participant's satisfaction with this means of data collection.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • English speaking

  • Screened or participating in NCT04253977

  • Able to give informed consent for participation

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

  • Principal Investigator: Debra Haire-Joshu, PhD, Washington University School of Medicine
  • Principal Investigator: Victor G Davila-Roman, MD,FACC,FASE, Washington University School of Medicine
  • Principal Investigator: Rachel G Tabak, PhD, RD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT05725746
Other Study ID Numbers:
  • 202212059
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 13, 2023