Community Based Treatment for (ComBaT) Glaucoma

Not Applicable

Recruiting

• Conditions: Glaucoma
• Interventions: Behavioral: ComBaT Glaucoma

• Registration Number: NCT06124521
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-09
• Study Start: 2024-10-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eye concern	ComBaT Glaucoma	Those with a diagnosis of glaucoma or glaucoma suspect (or other concerning eye disease, such as diabetic retinopathy or macular degeneration) will be invited to participate in the ComBaT Glaucoma.

Primary Outcome Measures

Name	Time	Method
Eye care utilization	Up to 14 months	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.

Trial Locations

Locations (2)

Historic King Solomon Baptist Church; 🇺🇸 Detroit, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States