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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02090777
Other study ID # Pro00052498
Secondary ID
Status Completed
Phase N/A
First received March 14, 2014
Last updated February 17, 2016
Start date May 2014
Est. completion date April 2015

Study information

Verified date January 2016
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

Glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Health Coach


Locations

Country Name City State
United States Duke Eye Center Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 Months No
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