The Support, Educate, Empower (SEE) Program (SEE)
Primary Purpose
Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Glaucoma Coaching
Enhanced Standard care
Sponsored by
About this trial
This is an interventional health services research trial for Glaucoma focused on measuring Ophthalmology, Glaucoma, Medication Adherence, Motivational Interviewing, Tailored Education, Self Management
Eligibility Criteria
Inclusion Criteria:
- Taking greater or equal to 1 ocular hypotensive medication with a diagnosis of any kind of glaucoma, suspected glaucoma or ocular hypertension
- Did not opt-out from recruitment letter
Exclusion Criteria:
- Do not speak English
- Have a diagnosed serious mental illness (for example, Schizophrenia)
- Diagnosed cognitive impairment
- Do not instill their own eye drops
- Had laser or incisional glaucoma surgery within three months of enrollment or scheduled during the six-month study period
- Unable to attend all study visits
- Active ocular infection or uveitis
Sites / Locations
- University of MichiganRecruiting
- Henry Ford HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Personalized Glaucoma Coaching
Enhanced standard care
Arm Description
Outcomes
Primary Outcome Measures
Mean electronically monitored medication adherence at six months
Medication adherence will be measured objectively using electronic monitors with a bottle-in-bottle technique where all glaucoma medications are placed inside electronic pill bottles. An adherent event is defined as using an eye drop medication within a specified time window of a dose on the previous day. Adherence will be calculated as the proportion of doses taken on time divided by total doses prescribed over the six-month study period. For participants on more than one medication, adherence will be first measured at the medication level and then aggregated to the person level by dividing the total number of doses of all medication(s) taken on time by the total number of doses prescribed. Mean medication adherence will be compared at six months between the intervention and control groups.
Proportion of patients that are ≥80% adherent to their glaucoma medications by electronic monitoring will be compared at 6 months between the intervention and control groups.
Secondary Outcome Measures
Glaucoma-related Distress
Glaucoma-related Distress will be measured by the Diabetes Distress Scale adapted for glaucoma, a 17-item scale where a higher score indicates a higher distress level. Mean Glaucoma-related Distress will be compared at 6 months between the intervention and control groups.
Full Information
NCT ID
NCT04735653
First Posted
January 28, 2021
Last Updated
March 24, 2023
Sponsor
University of Michigan
Collaborators
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT04735653
Brief Title
The Support, Educate, Empower (SEE) Program
Acronym
SEE
Official Title
Support, Educate, Empower: The SEE Personalized Glaucoma Coaching Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Eye Institute (NEI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will test whether the Support, Educate, Empower (SEE) personalized Glaucoma Coaching Program improves eye drop medication adherence among glaucoma patients compared to enhanced standard care in a randomized controlled clinical trial. As a secondary outcome, the study will test whether glaucoma related distress decreases among SEE program participants compared to the control group.
The study hypothesis is that glaucoma patients with poor adherence who receive motivational-interviewing based counseling and personalized education from a trained non-physician glaucoma coach through the SEE Program will improve their medication adherence compared to glaucoma patients standard care enhanced by additional educational handouts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Ophthalmology, Glaucoma, Medication Adherence, Motivational Interviewing, Tailored Education, Self Management
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Personalized Glaucoma Coaching
Arm Type
Experimental
Arm Title
Enhanced standard care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Personalized Glaucoma Coaching
Intervention Description
This is a six-month personalized glaucoma coaching program where a coach trained in motivational interviewing (MI)-based counseling uses a web based tool that generates tailored education to help glaucoma patients identify their barriers to optimal medication adherence and explore potential solutions during three in-person coaching sessions. The coach provides between-session support through four phone calls, with two phone calls between the first and second session and one phone call after each subsequent session. Participants can elect to receive any of the following type of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Standard care
Intervention Description
Participants will receive non-tailored educational materials about glaucoma from leading sources by mail every 2 months for a total of 3 mailings during the 6-month study period. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.
Primary Outcome Measure Information:
Title
Mean electronically monitored medication adherence at six months
Description
Medication adherence will be measured objectively using electronic monitors with a bottle-in-bottle technique where all glaucoma medications are placed inside electronic pill bottles. An adherent event is defined as using an eye drop medication within a specified time window of a dose on the previous day. Adherence will be calculated as the proportion of doses taken on time divided by total doses prescribed over the six-month study period. For participants on more than one medication, adherence will be first measured at the medication level and then aggregated to the person level by dividing the total number of doses of all medication(s) taken on time by the total number of doses prescribed. Mean medication adherence will be compared at six months between the intervention and control groups.
Time Frame
Up to 6 months
Title
Proportion of patients that are ≥80% adherent to their glaucoma medications by electronic monitoring will be compared at 6 months between the intervention and control groups.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Glaucoma-related Distress
Description
Glaucoma-related Distress will be measured by the Diabetes Distress Scale adapted for glaucoma, a 17-item scale where a higher score indicates a higher distress level. Mean Glaucoma-related Distress will be compared at 6 months between the intervention and control groups.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Taking greater or equal to 1 ocular hypotensive medication with a diagnosis of any kind of glaucoma, suspected glaucoma or ocular hypertension
Did not opt-out from recruitment letter
Exclusion Criteria:
Do not speak English
Have a diagnosed serious mental illness (for example, Schizophrenia)
Diagnosed cognitive impairment
Do not instill their own eye drops
Had laser or incisional glaucoma surgery within three months of enrollment or scheduled during the six-month study period
Unable to attend all study visits
Active ocular infection or uveitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phalatha McHaney-Conner
Phone
734-232-8057
Email
pmchaney@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Winter, MS
Phone
734-232-8185
Email
wsuzanne@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Newman-Casey, MD MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phalatha McHaney-Conner
Phone
734-232-8057
Email
pmchaney@umich.edu
First Name & Middle Initial & Last Name & Degree
Paula Newman-Casey, MD
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Thomas
Phone
313-916-7283
Email
mthoma22@hfhs.org
First Name & Middle Initial & Last Name & Degree
Deborah Darnley-Fisch, MD
Phone
313-916-9454
Email
DDARNLE1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Deborah Darnley-Fisch
12. IPD Sharing Statement
Plan to Share IPD
No
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The Support, Educate, Empower (SEE) Program
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