Community Based Treatment for (ComBaT) Glaucoma

Glaucoma Clinical Trial

Official title:

Increasing Eye Care Utilization in Black Americans At High Risk For Glaucoma Using A Community-Engaged and Faith-Based Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06124521
• Other study ID #: HUM00207876
• Secondary ID: K23MD016430-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Alexis Kendricks
• Phone: 734-232-8100
• Email: bluea[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to evaluate if intervention and education can change the behavior of someone's willingness to see an eye care provider to prevent blindness and glaucoma. The researchers are investigating if adding additional resources improves participant access to care.

Description:

Outcome measures related to acceptability and feasibility are exploratory. They will not be registered or results reported.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Black or African American

• Participated in the screening examination portion of the study

Exclusion Criteria:

• Current eye pain (> 8 out of 10)

• Sudden decrease in vision (within 1 week)

• Double vision that doesn't stop when you blink and stops no matter what eye you cover (not blurred, but seeing 2 objects)

• Pregnant women

• Prisoners

• Cognitive impairment- unable to give an ocular and social history

• Moving outside of Michigan or driving distance to the church within 6 months

Related Conditions & MeSH terms

• Glaucoma

Intervention

Behavioral:
• ComBaT Glaucoma
ComBaT Glaucoma is a personalized counseling and education program about the participant's diagnosis and the importance of glaucoma follow-up care in maintaining vision.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eye care utilization	Participants who have not seen an eye care provider for an initial clinical evaluation within 6 months of entering the program or a follow-up evaluation at 12 months will be considered underutilizers. Those who have received evaluation at 6 and 12 months will be considered normal utilizers.	Up to 14 months