GlaucomaNCT06124521
Community Based Treatment for (ComBaT) Glaucoma
A study testing ComBaT Glaucoma in people with Glaucoma, run by University of Michigan at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- ComBaT Glaucoma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Oct 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black or African American
- Participated in the screening examination portion of the study
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Jade Livingston, 734-232-8100, lijade@med.umich.edu
Angela Elam
- Recruiting
Historic King Solomon Baptist Church
Detroit, Michigan, 48208
Phalatha McHaney-Conner, BS, 734-945-6046, pmchaney@med.umich.edu
Angela Elam
About this study
Official title: Increasing Eye Care Utilization in Black Americans At High Risk For Glaucoma Using A Community-Engaged and Faith-Based Intervention
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.
Read the detailed description
Outcome measures related to acceptability and feasibility are exploratory. They will not be registered or results reported.
- Conditions
- Glaucoma
- Being tested
- ComBaT Glaucoma
- Keywords
- Eye Care, Care utilization, Community-based, Faith-based, Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComBaT GlaucomaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ComBaT Glaucoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start18 Oct 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Angela Elam, University of Michigan
- Investigators
- Angela Elam, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124521
- Sponsor's protocol ID
- HUM00207876
- Other IDs
- K23MD016430-04
- Status last verified
- Mar 2026
- First submitted
- 3 Nov 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Eye Care Utilization in Black Americans At High Risk For Glaucoma Using A Community-Engaged and Faith-Based Intervention
- ClinicalTrials.gov ID
- NCT06124521
- Acronym / sponsor ID
- HUM00207876
- Conditions
- Glaucoma
- Keywords
- Eye Care, Care utilization, Community-based, Faith-based, Glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eye concern | Experimental | Behavioral: ComBaT GlaucomaThose 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Black or African American
- Participated in the screening examination portion of the study
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ComBaT GlaucomaComBaT Glaucoma is a personalized counseling and education program about the participant's diagnosis and the importance of glaucoma follow-up care in maintaining vision. | Behavioural | Eye concern |
Primary outcome
Eye care utilization
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Elam principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ComBaT Glaucoma in people with Glaucoma, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phalatha McHaney-Conner, BS (734-945-6046, pmchaney@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye care utilization (time frame: Up to 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026; AzTrials last refreshed its copy on 28 Oct 2026.