Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 40 of 1615 for:    glaucoma

Improving African American Glaucoma Patient Involvement in Visits and Outcomes

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03657147
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
This is a research project about services provided to African American patients with glaucoma. The goal of the project is to improve communication between providers and African-American patients about glaucoma.

Condition or disease Intervention/treatment Phase
Glaucoma Behavioral: Educational Video and Question Prompt List Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving African American Glaucoma Patient Involvement in Visits and Outcomes
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Question Prompt List and Video
Participants will watch an educational video and question prompt list will be provided. Glaucoma visits will be audio-taped. A 15-20-minute interview will be conducted after the visit by a research assistant.
Behavioral: Educational Video and Question Prompt List
A short educational video will be presented on an iPad about the importance of encouraging patients to ask questions and to be involved during glaucoma visits to improve self-management skills. A question prompt list will also be completed where participants check questions of interest to ask the provider.

No Intervention: Usual Care
The usual care group will not receive any intervention. Glaucoma visits will be audio-taped. A 15-20-minute interview will be conducted after the visit by a research assistant.



Primary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: 12 months ]
    Intraocular pressure measurements will be extracted from each patient's medical record at the baseline, 6 month, and 12 month follow-up visits. For all time points, a mean intraocular pressure will be calculated by averaging the intraocular pressure across both eyes. Change in intraocular pressure over the 12 month period will then be assessed by calculating the difference in mean intraocular pressure.

  2. Glaucoma Medication Percent Adherence [ Time Frame: 12 months ]
    Medication adherence will be measured using the number of recorded doses from the Medication Event Monitoring System (MEMS) data, divided by the number of prescribed doses. Medication adherence can range from 0% to 100%.

  3. Glaucoma Medication Adherence Self-Efficacy Score [ Time Frame: 12 months ]
    Medication adherence self-efficacy is measured using a 21-item scale that has a reliability of 0.89. Scores can range from 21 to 63, and a higher score indicates a better outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American
  • Age 18 or older
  • Able to speak and read English
  • Mentally competent to participate
  • Not blind (are at least 20/400 in their better seeing eye)
  • On one or more glaucoma medications
  • Report being less than 80% adherent to their glaucoma medications on a Visual Analog Scale

Exclusion Criteria:

  • < 18 years of age

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): NCT03657147


Contacts
Layout table for location contacts
Contact: Betsy Sleath, PhD 919-962-0079 betsy_sleath@unc.edu
Contact: Nacire Garcia, MS 919-966-7923 nacire_garcia@med.unc.edu

Locations
Layout table for location information
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Betsy Sleath, PhD    919-962-0079    betsy_sleath@unc.edu   
Contact: Nacire Garcia, MS    919-966-7923    nacire_garcia@med.unc.edu   
Principal Investigator: Betsy Sleath, PhD         
Sub-Investigator: Delesha Carpenter, PhD         
Sub-Investigator: Donald Budenz, MD         
Sub-Investigator: Charles Lee, MD         
Sub-Investigator: Gail Tudor, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Layout table for investigator information
Principal Investigator: Betsy Sleath, PhD University of North Carolina, Chapel Hill

Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03657147     History of Changes
Other Study ID Numbers: 17-0688
1R01HS025370-01 ( U.S. AHRQ Grant/Contract )
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Ocular Hypertension
Eye Diseases