NCT02090777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 14, 2016

Completed
Last Updated

March 14, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

March 14, 2014

Results QC Date

November 6, 2015

Last Update Submit

February 17, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Health Coach

OTHER

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

Behavioral: Health Coach

Interventions

Health CoachBEHAVIORAL
Health Coach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient should be excluded if he or she may need glaucoma surgery or laser during the 6 months of the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
Jullia Rosdahl MD PhD
Organization
Duke Eye Center

Study Officials

  • Jullia Rosdahl, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 18, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

March 14, 2016

Results First Posted

March 14, 2016

Record last verified: 2016-01

Locations