Back to resultsHealth Coaching for Glaucoma Patients
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Coach
Sponsored by
About this trial
This is an interventional health services research trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Adult whose age is >18 years
- Diagnosed with glaucoma
- Patient of Duke Glaucoma Service
- Prescribed or using topical glaucoma eye medication for at least 6 months
- Primarily self-administering his or her eye drops
- English speaking
- Patient should be able to use the telephone for the coaching intervention,
- Patient should be available by phone to complete the coaching intervention
- Patient should be willing and able to use the MEMS (Medication Event Monitoring System) device for recording medication use
- Patient must be willing and able to come to the Eye Center for an exit interview and to return the MEMS device
- Patient must be able to give consent
Exclusion Criteria:
- Patient should be excluded if he or she may need glaucoma surgery or laser during the 6 months of the study period
Sites / Locations
- Duke Eye Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Health Coach
Arm Description
Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.
Outcomes
Primary Outcome Measures
Glaucoma Medication Adherence
Glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage. The average of the participants percentage of time they adhered to using the medication will be reported.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02090777
Brief Title
Health Coaching for Glaucoma Patients
Official Title
Health Coaching for Glaucoma Patients, Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will be conducted to examine the feasibility of using a Health Coach for improving the ophthalmic care of glaucoma patients. Patients taking glaucoma medications will have a coaching intervention and adherence to glaucoma drops will be monitored using a dose-recording device. The dosing data will be analyzed to examine the effect on adherence and qualitative interviews at the conclusion of the study will be used to examine which elements of the coaching experience were most helpful in the glaucoma patient population.
Detailed Description
Glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health Coach
Arm Type
Other
Arm Description
Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.
Intervention Type
Behavioral
Intervention Name(s)
Health Coach
Primary Outcome Measure Information:
Title
Glaucoma Medication Adherence
Description
Glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage. The average of the participants percentage of time they adhered to using the medication will be reported.
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult whose age is >18 years
Diagnosed with glaucoma
Patient of Duke Glaucoma Service
Prescribed or using topical glaucoma eye medication for at least 6 months
Primarily self-administering his or her eye drops
English speaking
Patient should be able to use the telephone for the coaching intervention,
Patient should be available by phone to complete the coaching intervention
Patient should be willing and able to use the MEMS (Medication Event Monitoring System) device for recording medication use
Patient must be willing and able to come to the Eye Center for an exit interview and to return the MEMS device
Patient must be able to give consent
Exclusion Criteria:
Patient should be excluded if he or she may need glaucoma surgery or laser during the 6 months of the study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jullia Rosdahl, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Health Coaching for Glaucoma Patients
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