Community Based Treatment for (ComBaT) Glaucoma

Sponsor

University of Michigan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06124521

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Behavioral: ComBaT Glaucoma	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2026

Anticipated Study Completion Date :

Nov 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eye concern 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.	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.

Arm

Intervention/Treatment

Experimental: Eye concern

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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