GlaucomaSIGHTNCT04274764
Screening and Intervention for Glaucoma and Eye Health Through Telemedicine
A study testing Personalized eHealth Education & Motivational Interviewing in people with Glaucoma, run by University of Michigan at 2 sites in United States.
Trial summary
This is a multiple site, randomized study that will assess the effects of personalized eHealth education and motivational-interviewing-based counseling on patient adherence to physician follow-up appointments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Personalized eHealth Education & Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 622 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jul 2020to 28 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > or = to 18 years of age
Who cannot join
- Sudden vision changes
- Significant eye pain
- Pregnant women
- Prisoners
- Cognitive impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hamilton Community Health Clinic
Flint, Michigan, 48505
Hope Clinic
Ypsilanti, Michigan, 48197
About this study
Official title: Sustainable Community Clinic Telemedicine-Based Glaucoma Screening
This is a multiple site, randomized study that will assess the effects of personalized eHealth education and motivational-interviewing-based counseling on patient adherence to physician follow-up appointments.
Read the detailed description
The primary objective of this study is to evaluate the effects of personalized eHealth education and motivational-interviewing-based counseling on adherence to glaucoma follow-up care compared to standard education delivered by a trained staff member. Participants will be randomized in a 1:1 ratio to either standard education and care navigation or eHealth education, counseling and care navigation. The outcome measure of the participant seeing an Ophthalmologist for follow up care within 3 months was increased to 6 months. This modification was made due to ophthalmology visit appointments not being available within the 3-month timeframe.
This study is embedded in a CDC-funded program to engage people from medically underserved areas in glaucoma screening. Participants who screened positive for glaucoma or suspected glaucoma were randomized in a 1:1 ratio to either the standard education and care navigation arm or the eHealth education, counseling, and care navigation arm.
- Conditions
- Glaucoma
- Being tested
- Personalized eHealth Education & Motivational Interviewing
- Keywords
- Telemedicine, Motivational interviewing, Health Coaching
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized eHealth Education & Motivational InterviewingBehavioural
This intervention uses a web-based application to generate personalized education materials for patients based on their eye health screening results and barriers to follow up care. A glaucoma counselor trained in brief, glaucoma-specific motivational interviewing (MI) uses the individualized content generated from this web-based application to form the basis of her conversation with the patient to coach the patient to engage in follow-up care.
| Study group | Role | What they receive |
|---|---|---|
| Personalized eHealth Education & Motivational Interviewing | Experimental | Personalized eHealth Glaucoma Education \& Motivational Interviewing Receives: Behavioral: Personalized eHealth Education & Motivational Interviewing |
| Standard Education | No intervention | Participant will receive standard glaucoma education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Follow up
Results reflect the count of participants who were seen by an ophthalmologist for follow-up care within 6 months of their recommended appointment time, and those who did not attend the scheduled follow-up appointment.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start28 Jul 2020
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned at a 1:1 ratio to the study intervention.
- Masking
- None (open label)
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Paula Anne Newman-Casey, University of Michigan
- Investigators
- Paula Anne Newman-Casey, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274764
- Sponsor's protocol ID
- HUM00169371
- Other IDs
- 5-U01-DP-006442-05-00, 5U01DP006442-05
- Acronym
- SIGHT
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2020
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Newman-Casey PA, Killeen O, Miller S, MacKenzie C, Niziol LM, Resnicow K, Creswell JW, Cook P, Heisler M. A Glaucoma-Specific Brief Motivational Interviewing Training Program for Ophthalmology Para-professionals: Assessment of Feasibility and Initial Patient Impact. Health Commun. 2020 Feb;35(2):233-241. doi: 10.1080/10410236.2018.1557357. Epub 2018 Dec 20.
PubMed 31878800Flaharty K, Niziol LM, Woodward MA, Elam A, Bicket A, Killeen OJ, Zhang J, Johnson L, Kershaw M, John DA, Wood SK, Musch DC, Newman-Casey PA. Association of Contrast Sensitivity With Eye Disease and Vision-Related Quality of Life. Am J Ophthalmol. 2024 May;261:176-186. doi: 10.1016/j.ajo.2024.01.021. Epub 2024 Jan 26.
PubMed 38281569Newman-Casey PA, Aliancy J, Lu MC, Woodward MA, Hicks PM, Niziol LM, Musch DC, Bicket AK, John D, Killeen O, Wood SD, Johnson L, Kershaw M, Zhang J, Elam AR. Social Deprivation and the Risk of Screening Positive for Glaucoma in the MI-SIGHT Telemedicine-Based Glaucoma Detection Program. Ophthalmology. 2023 Oct;130(10):1053-1065. doi: 10.1016/j.ophtha.2023.05.021. Epub 2023 May 19.
PubMed 37211338
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Community Clinic Telemedicine-Based Glaucoma Screening
- ClinicalTrials.gov ID
- NCT04274764
- Acronym / sponsor ID
- SIGHT / HUM00169371
- Conditions
- Glaucoma
- Keywords
- Telemedicine, Motivational interviewing, Health Coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Posted 20 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multiple site, randomized study that will assess the effects of personalized eHealth education and motivational-interviewing-based counseling on patient adherence to physician follow-up appointments.
Detailed description
The primary objective of this study is to evaluate the effects of personalized eHealth education and motivational-interviewing-based counseling on adherence to glaucoma follow-up care compared to standard education delivered by a trained staff member. Participants will be randomized in a 1:1 ratio to either standard education and care navigation or eHealth education, counseling and care navigation. The outcome measure of the participant seeing an Ophthalmologist for follow up care within 3 months was increased to 6 months. This modification was made due to ophthalmology visit appointments not being available within the 3-month timeframe.
This study is embedded in a CDC-funded program to engage people from medically underserved areas in glaucoma screening. Participants who screened positive for glaucoma or suspected glaucoma were randomized in a 1:1 ratio to either the standard education and care navigation arm or the eHealth education, counseling, and care navigation arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned at a 1:1 ratio to the study intervention.
| Arm | Type | Receives |
|---|---|---|
| Personalized eHealth Education & Motivational Interviewing | Experimental | Behavioral: Personalized eHealth Education & Motivational InterviewingPersonalized eHealth Glaucoma Education \& Motivational Interviewing |
| Standard Education | No intervention | –Participant will receive standard glaucoma education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- > or = to 18 years of age
Key exclusion criteria (5 listed)
- Sudden vision changes
- Significant eye pain
- Pregnant women
- Prisoners
- Cognitive impairment
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 |
|---|---|---|
| Personalized eHealth Education & Motivational InterviewingThis intervention uses a web-based application to generate personalized education materials for patients based on their eye health screening results and barriers to follow up care. A glaucoma counselor trained in brief, glaucoma-specific motivational interviewing (MI) uses the individualized content generated from this web-based application to form the basis of her conversation with the patient to coach the patient to engage in follow-up care. | Behavioural | Personalized eHealth Education & Motivational Interviewing |
Primary outcome
Physician Follow up
Time frame: Up to 18 months
Results reflect the count of participants who were seen by an ophthalmologist for follow-up care within 6 months of their recommended appointment time, and those who did not attend the scheduled follow-up appointment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31878800Newman-Casey PA, Killeen O, Miller S, MacKenzie C, Niziol LM, Resnicow K, Creswell JW, Cook P, Heisler M. A Glaucoma-Specific Brief Motivational Interviewing Training Program for Ophthalmology Para-professionals: Assessment of Feasibility and Initial Patient Impact. Health Commun. 2020 Feb;35(2):233-241. doi: 10.1080/10410236.2018.1557357. Epub 2018 Dec 20.
- Derived from this study: PubMed 38281569Flaharty K, Niziol LM, Woodward MA, Elam A, Bicket A, Killeen OJ, Zhang J, Johnson L, Kershaw M, John DA, Wood SK, Musch DC, Newman-Casey PA. Association of Contrast Sensitivity With Eye Disease and Vision-Related Quality of Life. Am J Ophthalmol. 2024 May;261:176-186. doi: 10.1016/j.ajo.2024.01.021. Epub 2024 Jan 26.
- Derived from this study: PubMed 37211338Newman-Casey PA, Aliancy J, Lu MC, Woodward MA, Hicks PM, Niziol LM, Musch DC, Bicket AK, John D, Killeen O, Wood SD, Johnson L, Kershaw M, Zhang J, Elam AR. Social Deprivation and the Risk of Screening Positive for Glaucoma in the MI-SIGHT Telemedicine-Based Glaucoma Detection Program. Ophthalmology. 2023 Oct;130(10):1053-1065. doi: 10.1016/j.ophtha.2023.05.021. Epub 2023 May 19.
- Hope ClinicLink provided by the sponsor.
- Hamilton ClinicLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Paula Anne Newman-Casey, MD 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 Personalized eHealth Education & Motivational Interviewing 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 20 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Follow up (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04274764, which also lists 3 linked publications.
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 20 Mar 2025.