NCT06124521

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress65%
Oct 2024May 2027

First Submitted

Initial submission to the registry

November 3, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

October 18, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

November 3, 2023

Last Update Submit

March 3, 2026

Conditions

Keywords

Eye CareCare utilizationCommunity-basedFaith-basedGlaucoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Eye concern

EXPERIMENTAL

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

Interventions

ComBaT GlaucomaBEHAVIORAL

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.

Eye concern

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Black or African American
  • Participated in the screening examination portion of the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Historic King Solomon Baptist Church

Detroit, Michigan, 48208, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Angela Elam

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phalatha McHaney-Conner, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology and Visual Sciences

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 9, 2023

Study Start

October 18, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations