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Trial record 61 of 1410 for:    "glaucoma" OR "early-onset glaucoma"

Glaucoma Management Optimism for African Americans Living With Glaucoma (GOAL)

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ClinicalTrials.gov Identifier: NCT03159481
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Laura E. Dreer, PhD, University of Alabama at Birmingham

Brief Summary:

African Americans (AA) are at higher risk to develop and go blind from glaucoma than Caucasians. While glaucoma medications can help delay disease progression and possible blindness, problems with poor adherence have been documented for both racial groups, with a greater prevalence among AA. Of the very few interventions targeting glaucoma medication adherence studied to date, several methodological limitations persist. For example, few have been subjected to rigorous randomized clinical trial (RCT) designs, the intervention itself was designed and studied predominantly among Caucasians and thereby limiting generalizability, the effects on adherence have been short-term, most have been evaluated on small sample sizes, and/or the focus of the intervention was solely on providing patient education regarding eye disease and management. Needed in this important yet understudied area are culturally-relevant, health promotion-based approaches which are 1) targeted to high risk populations, 2) theoretically driven, 3) relevant to the beliefs, language, and values of underserved populations as well as challenges related to glaucoma medication adherence, 4) designed to promote preparation and readiness to engage in healthy behaviors, and 5) train patients in skills to use in order to more effectively problem-solve ongoing obstacles related to adherence.

The investigators published a paper in the Journal of Glaucoma investigating determinants related to objective medication adherence as measured by an electronic dosing aid (DA). Findings revealed poorer rates of adherence among AA patients with glaucoma compared to Caucasian patients with glaucoma. Evidence for racial differences in adherence have also been increasingly documented in the glaucoma literature. In a follow-up study with focus groups of AA's with glaucoma that was published in Optometry and Vision Sciences, the goal was to identify the specific barriers and facilitators related to glaucoma medication adherence among this high-risk group. Several key themes emerged such as patient, provider, and socioeconomic factors, along with barriers in views of health, perceived harm from treatment, costs, avoidant coping styles, forgetfulness, and in eyedrop administration/scheduling. The investigators used these results along with guidance from a consumer advisory board consisting of AA patients with glaucoma in order to develop and pilot test the resulting culturally relevant, health promotion-based intervention. The pilot data demonstrated feasibility and favorable preliminary efficacy for the intervention to significantly improve medication adherence to further pursue in a clinical trial.


Condition or disease Intervention/treatment Phase
Glaucoma Behavioral: Usual Care + Health Promotion Intervention Not Applicable

Detailed Description:

Aim 1: To evaluate the efficacy of a culturally relevant, health promotion-based intervention to increase rates of glaucoma medication adherence among AA patients with glaucoma as compared to usual care.

Aim 2: To longitudinally examine the associations between medical, demographic, cultural, socioeconomic, and ocular factors and objective medication adherence rates among AA's with glaucoma in the usual care only group. This aim will explore what factors are associated with glaucoma medication adherence, as defined by objective adherence measures, during usual care. This information will facilitate hypothesis generation and testing for future studies.

Aim 3: To longitudinally examine the associations between medical, demographic, cultural, socioeconomic, and ocular factors and objective medication adherence rates among AA's with glaucoma in the treatment arm (those receiving the treatment intervention). This aim will explore what patient-related factors are more or less likely to relate to the effectiveness of the intervention as defined by objective adherence. This information is useful for understanding which patients may ultimately most responsive to the intervention.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Blinded to arm assignment.
Primary Purpose: Treatment
Official Title: Enhancing Glaucoma Medication Adherence Among African Americans
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Usual Care + Health Promotion Intervention
Usual glaucoma care along with telehealth-based brief culturally informed health promotion intervention
Behavioral: Usual Care + Health Promotion Intervention
Telephone sessions for approximately 5-6 weeks to enhance empowerment and skills for managing medication adherence.
Other Name: GOAL

No Intervention: Usual Care Only
Usual glaucoma management only, no intervention.



Primary Outcome Measures :
  1. Change in medication rate adherence via an electronic dosing aid [ Time Frame: Baseline, 3, 7 months, and 1 year ]
    Assessment in medication adherence will be obtained via an electronic dosing aid which tracks medication behavior (e.g., attempts to dispense eye drops).


Secondary Outcome Measures :
  1. Knowledge of glaucoma management [ Time Frame: Baseline, 3, 7 months, and 1 year ]
    This is an 11-item self-report measure of Patient Satisfaction with Glaucoma Treatment (Glaustat) that will be used to understand patients' knowledge of glaucoma and its management.

  2. Glaucoma symptoms [ Time Frame: Baseline, 3, 7 months, and 1 year ]
    The investigators will use the Glaucoma Symptom Scale to assess visual and nonvisual symptoms which developed from a modified version of a checklist used in the Ocular Hypertension Treatment Study. It has 10 items that ask respondents whether they have experienced certain symptoms (e.g., dryness) in the prior 4 weeks and to what extent they were bothered by these symptoms.

  3. Health beliefs and illness perception [ Time Frame: Baseline, 3, 7 months, and 1 year ]
    The 18-item Beliefs about Medicines Questionnaire (BMQ) will be used to assess patients' concerns about present/potential future adverse effects from their medications and their beliefs regarding the necessity of their medications. Scores are summed within each scale to create an overall scale score (range: 8-40 for a 'necessity scale' and 10-50 for a 'concerns scale'.

  4. Social problem-solving skills [ Time Frame: Baseline, 3, 7 months, and 1 year ]
    The Social Problem-Solving Inventory-Revised is a 25-item, self-report measure of motivation for solving problems and problem-solving abilities. The SPSI-R is based on a five dimensional model of problem-solving ability which includes two theoretically defined components, both of which will be measured: problem orientation and problem-solving skills.

  5. Depressive symptomatology [ Time Frame: Baseline, 3, 7 months, and 1 year ]
    The investigators will use the nine items of the Patient Health Questionnaire-9 (PHQ-9) scale to assess depressive symptomatology. The total score is calculated by summing each of the PHQ-9 items with higher scores indicating the presence of greater depressive symptomatology. The criterion, construct and external validity of the PHQ-9 have been well established using large medical samples.


Other Outcome Measures:
  1. Sociodemographic variables [ Time Frame: Baseline, 3, 7 months, and 1 year ]
    The investigators will evaluate the influence of several sociodemographic factors on outcomes (e.g., gender, income).

  2. Medical factors [ Time Frame: Baseline, 3, 7 months, and 1 year ]
    The investigators will also characterize ocular variables and other health related factors (e.g., intraocular pressure, degree of field loss, other medical conditions.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age ≥ 21 years old
  2. AA
  3. have one of the following diagnoses: open-angle glaucoma, angle-closure glaucoma, glaucoma suspect, or ocular hypertension (OHTN) in one or both eyes
  4. using or prescribed a topical prostaglandin analog
  5. not to have undergone past laser or surgical glaucoma therapy within 3 months before the study
  6. have two reliable visual fields over the past 2 years
  7. English-speaking
  8. cognitively oriented as defined by the Six-Item Screener (SIS) score of > 4 of 6
  9. have access to a telephone,
  10. agrees to random assignment to either arm of study
  11. agrees to return for all follow-up visits
  12. patient has been determined to be 80% or less adherent.

Exclusion Criteria:

  1. cognitively unable to understand the study
  2. does not instill their own eye drops
  3. incapable of using the electronic MEMS bottle/cap after a brief practice session
  4. known contraindications to Travoprost
  5. has a severe hearing impairment impeding communication.

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): NCT03159481


Contacts
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Contact: Laura Dreer, Ph.D. (205) 325-8681 laurdreer@uabmc.edu

Locations
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United States, Alabama
UAB Recruiting
Birmingham, Alabama, United States, 35294
Contact: Laura Dreer, Ph.D.         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Laura Dreer, Ph.D. University of Alabama at Birmingham

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Responsible Party: Laura E. Dreer, PhD, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03159481     History of Changes
Other Study ID Numbers: 9070592
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases