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| ID | Type | Description | Link |
|---|---|---|---|
| 5-U01-DP-006442-05-00 | Other Grant/Funding Number | Centers for Disease Control and Prevention | |
| 5U01DP006442-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized eHealth Education & Motivational Interviewing | Experimental | Personalized eHealth Glaucoma Education & Motivational Interviewing |
|
| Standard Education | No Intervention | Participant will receive standard glaucoma education. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized eHealth Education & Motivational Interviewing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 18 months |
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Inclusion Criteria:
- > or = to 18 years of age
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula Anne Newman-Casey, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Community Health Clinic | Flint | Michigan | 48505 | United States | ||
| Hope Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31878800 | Background | 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. | |
| 38281569 | Derived | Flaharty 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. |
| Label | URL |
|---|---|
| Hope Clinic | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Personalized eHealth Education & Motivational Interviewing | Personalized eHealth Glaucoma Education & Motivational Interviewing Personalized eHealth Education & Motivational Interviewing: 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. |
| FG001 | Standard Education | Participant will receive standard glaucoma education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants are included whose date of followup visit with an ophthalmologist was scheduled for a date prior to trial stop date, and therefore whose outcomes could be assessed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Personalized eHealth Education & Motivational Interviewing | Personalized eHealth Glaucoma Education & Motivational Interviewing Personalized eHealth Education & Motivational Interviewing: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 18 months |
|
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Adverse event data was not collected within the context of the educational trial because the intervention (personalized education and coaching) vs. control (standard education) were so low risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Personalized eHealth Education & Motivational Interviewing | Personalized eHealth Glaucoma Education & Motivational Interviewing Personalized eHealth Education & Motivational Interviewing: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paula Anne Newman-Casey | University of Michigan | 734 763-6967 | panewman@med.umich.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 29, 2024 | Jul 8, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 11, 2020 | May 8, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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Participants will be assigned at a 1:1 ratio to the study intervention.
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|
| Ypsilanti |
| Michigan |
| 48197 |
| United States |
| 37211338 | Derived | Newman-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. |
| Hamilton Clinic | View source |
| BG001 | Standard Education | Participant will receive standard glaucoma education. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Standard Education | Participant will receive standard glaucoma education. |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard Education | Participant will receive standard glaucoma education. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |