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Health Coaching for Glaucoma Patients

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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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Glaucoma
Intervention Behavioral: Health Coach
Enrollment 9
Recruitment Details 9 participants signed consent. 5 participants decided not to participate after signing consent and did not start study. 4 participants started and completed the study.
Pre-assignment Details  
Arm/Group Title Health Coach
Hide Arm/Group Description

Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.

Health Coach

Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Health Coach
Hide Arm/Group Description

Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.

Health Coach

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
Participants who completed this pilot study intervention are included in the analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
4
 100.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
73
(69 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
1
  25.0%
Male
3
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Glaucoma Medication Adherence
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Health Coach
Hide Arm/Group Description:

Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.

Health Coach

Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: percentage of adherence time
72  (27)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Health Coach
Hide Arm/Group Description

Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.

Health Coach

All-Cause Mortality
Health Coach
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Health Coach
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Health Coach
Affected / at Risk (%)
Total   0/4 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jullia Rosdahl MD PhD
Organization: Duke Eye Center
Phone: 919-684-8850
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02090777     History of Changes
Other Study ID Numbers: Pro00052498
First Submitted: March 14, 2014
First Posted: March 18, 2014
Results First Submitted: November 6, 2015
Results First Posted: March 14, 2016
Last Update Posted: March 14, 2016