Hypertension Clinical Trial
Official title:
Group-based Chronic Kidney Disease Care
NCT number | NCT02467894 |
Other study ID # | 2014-3117 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2014 |
Est. completion date | August 2017 |
Verified date | March 2019 |
Source | Albert Einstein College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A two-group randomized clinical trial testing whether group-based care is feasible and will help improve blood pressure control in adult and adolescent patients with chronic kidney disease and hypertension.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility |
Inclusion Criteria: - Adolescent Age =12 years old - Sufficient hearing, vision, and proficiency in English or Spanish to comprehend low- literacy printed educational materials and participate in group sessions (assessed by provider) - Adult: (¬>21 years): Systolic blood pressure >140 at two clinic visits in the past year or >160 at one visit and Adolescent: (12-21 years) systolic blood pressure >95 percentile (based on sex and age) at 2 clinic visits in the past year - For adults: Stage 3-5 CKD (eGFR<60 ml/min/1.73m2) - For adolescents: evidence of kidney damage (albuminuria, congenital anomalies of the kidney or urinary tract) and hypertension - Prescription for anti-hypertensive medication (in adults) - Unwillingness to accept random assignment - Unwillingness to provide informed consent Exclusion Criteria: - Transplanted organ - Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months - Plans to relocate out of New York City in the next 6 months |
Country | Name | City | State |
---|---|---|---|
United States | Albert Einstein College of Medicine | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Accelerometer | Evaluate effects of group-based care on physical activity | 6 months | |
Other | Medication Adherence | Measured by the Morisky 8-item Medication Adherence scale. | 6 months | |
Other | Quality of Life | We will collect quality of life measurements using the Peds QL in the adolescent group and the SF-36 in the adult sample. We want to evaluate whether group-based care may lead to improved or worse reported quality of life in participants. | 6 months | |
Other | Health Resources and Services Administration (HRSA) | Evaluate patient and provider satisfaction | 6 months | |
Primary | Blood pressure control | The primary outcome will be blood pressure control (mean SBP <140 mmHg) as measured by 24-hour ambulatory blood pressure monitor. | 6 months |
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