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Improving African American Glaucoma Patient Involvement in Visits and Outcomes

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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

Tracking Information
First Submitted Date  ICMJE August 28, 2018
First Posted Date  ICMJE September 3, 2018
Last Update Posted Date October 12, 2018
Actual Study Start Date  ICMJE September 10, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
  • 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.
  • 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%.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03657147 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving African American Glaucoma Patient Involvement in Visits and Outcomes
Official Title  ICMJE Improving African American Glaucoma Patient Involvement in Visits and Outcomes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Glaucoma
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Educational Video and Question Prompt List
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2018)
380
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Betsy Sleath, PhD 919-962-0079 betsy_sleath@unc.edu
Contact: Nacire Garcia, MS 919-966-7923 nacire_garcia@med.unc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03657147
Other Study ID Numbers  ICMJE 17-0688
1R01HS025370-01 ( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: Betsy Sleath, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP