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
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Behavioral: Educational Video and Question Prompt List||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||380 participants|
|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|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657147
|Contact: Betsy Sleath, PhDfirstname.lastname@example.org|
|Contact: Nacire Garcia, MSemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Nacire Garcia, MS 919-966-7923 email@example.com|
|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|
|Principal Investigator:||Betsy Sleath, PhD||University of North Carolina, Chapel Hill|