GUARDD-US
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StatusAccepting Candidates
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Age18 Years - 70 Years
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SexesAll
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Healthy VolunteersNo
Objective
The primary aim is to determine the effect of participant and provider knowledge of a positive APOL1 status and accompanying guideline based clinical decision support (CDS) on blood pressure management on change in systolic blood pressure (SBP) from baseline to 3 months after randomization among the APOL1 positive participants. Secondary aims are to:
Determine the effect of participant and provider knowledge of a positive APOL1 status on the probability of appropriate CKD diagnosis.
Determine the effect of participant and provider knowledge of a positive APOL1 status on the probability of receiving a urine microalbumin/creatinine testing and ACE-I/ARB prescription based on results of the urine microalbumin level.
Explore cost effectiveness, mediators, moderators, psychobehavioral impact of results disclosure on participants, and effects of participant and provider knowledge of APOL1 status on provider treatment recommendations.
PGX Substudy
In addition, GUARDD-US will include a substudy to determine the effect of knowledge of genetic test results that predict efficacy of various antihypertensive medications on change in SBP from baseline to 3 months in APOL1 negative individuals.
Approximately 6,650 participants of African ancestry age 18-70 with hypertension that either:
- do not have diabetes and do not have CKD, or 2. have CKD. Participants with diabetes may be included as long as they also have CKD.
Population for Main Study:
Participants from Randomized Population (above) who test positive for APOL1
Population for Pgx Substudy:
Participants from Randomized Population (above) randomized to Intervention and who test negative for APOL1
Main Study Analyses:
To determine the effect of participant and provider knowledge of a positive APOL1 status on SBP, we will compare the change in SBP from baseline to 3 months of the Intervention * APOL1 positive group to the change in SBP from baseline to 3 months of the Control - APOL1 positive group using a two sided t-test, as appropriate, with a two-sided type I error of 0.05.
The effect of knowledge of a positive APOL1 status on all secondary endpoints will be compared between Intervention APOL1 positives to Control APOL1 positives with the proportion difference test.
Additional analyses will include analysis of time trends in SBP, subset analyses, and exploratory analyses of cost effectiveness, mediators, moderators, psychobehavioral impact of results disclosure on participants, and effects of knowledge of APOL1 status on provider treatment recommendations.
Substudy Analyses:
All primary and secondary endpoint analyses conducted for the APOL1 main study will be repeated for the PGx substudy focusing on differences in outcomes between APOL1 negative individuals with immediate PGx ROR (PGx Intervention) and APOL1 negative individuals with delayed PGx ROR (PGx Control).
Details
Full study title | Genetic testing to Understand and Address Renal Disease Disparities across the United States (GUARDD-US) |
Protocol number | OCR30483 |
ClinicalTrials.gov ID | NCT04191824 |
Phase | N/A |
Eligibility
Inclusion Criteria:
Self reported African ancestry
English Speaking
Age 18-70 years
Have diagnosis of hypertension
Diagnosis of hypertension is defined by either:
ICD10 diagnosis codes (i.e., I10; I11.x; I12.x; I13.x; I16.x) OR
On active antihypertensive therapy for indication of hypertension OR
Having systolic blood pressure of 140 mm Hg or greater in at least 2 of the last 3 consecutive recorded values in the EHR OR
Having hypertension in the patient's medical record problem list
Have been seen at ≥1 time in past year at a participating primary care site
Either: 1) do not have diabetes and do not have CKD, or 2) have CKD;
Participants with diabetes may be included as long as they also have CKD.
CKD is defined by either:
- ICD10 codes (i.e., N18. x; E08. 22; E09. 22; E10. 22; E11. 22;E13. 22 (exclude Z94. 0; N18.6; Z99.2)) OR
15 ≤ eGFR ≤ 60 ml/min for 2 time periods ≥ 3 months
Diabetes is defined by:
HbA1c ≥ 6.5 at least one time in the last year OR
ICD10 diagnosis codes (see Appendix A) OR
Having diabetes in the patient's medical record problem list
Exclusion Criteria:
Have diabetes, but no CKD.
Are currently on dialysis (ICD 10 codes N18.6, Z99.2 and Z94.0)
Have ESRD (eGFR
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
Rhonda Dehoff -
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.