Health Coaching for Glaucoma Patients

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02090777
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 11
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Behavioral: Health Coach	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• 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 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Health Coach Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.	Behavioral: Health Coach

Outcome Measures

Primary Outcome Measures

1. Glaucoma Medication Adherence [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Duke Eye Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Jullia Rosdahl, MD, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02090777
• Other Study ID Numbers: Pro00052498
• First Posted: Mar 18, 2014
• Last Update Posted: Mar 14, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Glaucoma

Study Results

Participant Flow

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.

Arm/Group Title	Health Coach
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

Baseline Characteristics

Arm/Group Title	Health Coach
Arm/Group Description	Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients. Health Coach
Overall Participants	4
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	4 100%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	73
Sex: Female, Male (Count of Participants)
Female	1 25%
Male	3 75%
Region of Enrollment (participants) [Number]
United States	4 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Health Coach
Arm/Group Description	Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients. Health Coach
Measure Participants	4
Mean (Standard Deviation) [percentage of adherence time]	72 (27)

Adverse Events

Arm/Group Title	Health Coach
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Health Coach
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Other (Not Including Serious) Adverse Events
	Health Coach
	Affected / at Risk (%)	# Events
Total	0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.