Glaucoma
Conditions
Keywords
Telemedicine, Motivational interviewing, Health Coaching
Brief 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.
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.
Interventions
BEHAVIORALPersonalized 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.
Sponsors
Centers for Disease Control and Prevention
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be assigned at a 1:1 ratio to the study intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- \> or = to 18 years of age
Exclusion criteria
* Sudden vision changes * Significant eye pain * Pregnant women * Prisoners * Cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Follow up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 247 |
| Standard Education Participant will receive standard glaucoma education. | 243 |
| Total | 490 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Date of scheduled followup visit was after trial stop date | 62 | 70 |
Baseline characteristics
| Characteristic | Personalized eHealth Education & Motivational Interviewing | Total | Standard Education |
|---|---|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 14.2 | 58.4 years STANDARD_DEVIATION 14.5 | 58 years STANDARD_DEVIATION 14.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 14 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 200 Participants | 394 Participants | 194 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 39 Participants | 82 Participants | 43 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 164 Participants | 329 Participants | 165 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 17 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) White | 62 Participants | 111 Participants | 49 Participants |
| Region of Enrollment United States | 247 Participants | 490 Participants | 243 Participants |
| Sex/Gender, Customized Female | 149 Participants | 301 Participants | 152 Participants |
| Sex/Gender, Customized Male | 95 Participants | 183 Participants | 88 Participants |
| Sex/Gender, Customized Unknown/Refused/Prefer not to answer | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Up to 18 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Personalized eHealth Education & Motivational Interviewing | Physician Follow up | Adherent to recommended follow up | 150 Participants |
| Personalized eHealth Education & Motivational Interviewing | Physician Follow up | Not Adherent to recommended follow up | 97 Participants |
| Standard Education | Physician Follow up | Adherent to recommended follow up | 144 Participants |
| Standard Education | Physician Follow up | Not Adherent to recommended follow up | 99 Participants |
p-value: 0.7399Chi-squared