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Health Coaching for Glaucoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02090777
Recruitment Status : Completed
First Posted : March 18, 2014
Results First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glaucoma Behavioral: Health Coach Not Applicable

Detailed Description:
Glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Health Coaching for Glaucoma Patients, Pilot Study
Study Start Date : May 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Health Coach
Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.
 Behavioral: Health Coach


Outcome Measures
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Primary Outcome Measures :
  1. Glaucoma Medication Adherence [ Time Frame: 6 Months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090777


Locations
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United States, North Carolina
Duke Eye Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Jullia Rosdahl, MD, PhD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02090777    
Other Study ID Numbers: Pro00052498
First Posted: March 18, 2014    Key Record Dates
Results First Posted: March 14, 2016
Last Update Posted: March 14, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases