Back to resultsGroup-based Chronic Kidney Disease Care
Primary Purpose
Chronic Kidney Disease, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group-based Care
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Adherence, Exercise
Eligibility Criteria
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
Sites / Locations
- Albert Einstein College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group-based Care
Usual Care
Arm Description
Participants who are randomized to group-based care will attend monthly outpatient clinic visits as part of a group of 8-10 patients with CKD and hypertension.
Participants who are randomized to usual care will see their provider on clinic days when there is no group meeting.
Outcomes
Primary Outcome Measures
Blood pressure control
The primary outcome will be blood pressure control (mean SBP <140 mmHg) as measured by 24-hour ambulatory blood pressure monitor.
Secondary Outcome Measures
Full Information
NCT ID
NCT02467894
First Posted
June 8, 2015
Last Updated
March 11, 2019
Sponsor
Albert Einstein College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02467894
Brief Title
Group-based Chronic Kidney Disease Care
Official Title
Group-based Chronic Kidney Disease Care
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
This two-group RCT will enroll 100 subjects, adolescents over or equal to 12 years of age, and men and women over age of 21, with stage 3-4 and 5 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology. The primary aim will be to assess feasibility of the intervention.
Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.
Blood and 24 hr urine test will be collected to assess for sodium, phosphorus, and serum creatinine. These tests will be used for experimental purposes only and will be collected at enrollment and 6 months visit.
There will be two arms, an arm randomized to Group-based care attending monthly outpatient clinic visits as part of a group and the other to usual care who will see their provider once a month for 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hypertension
Keywords
Adherence, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group-based Care
Arm Type
Experimental
Arm Description
Participants who are randomized to group-based care will attend monthly outpatient clinic visits as part of a group of 8-10 patients with CKD and hypertension.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants who are randomized to usual care will see their provider on clinic days when there is no group meeting.
Intervention Type
Other
Intervention Name(s)
Group-based Care
Intervention Description
There will be self-care activities, blood pressure measurements and other vitals, including discussion of specific topics initiated by the participants.
Primary Outcome Measure Information:
Title
Blood pressure control
Description
The primary outcome will be blood pressure control (mean SBP <140 mmHg) as measured by 24-hour ambulatory blood pressure monitor.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Accelerometer
Description
Evaluate effects of group-based care on physical activity
Time Frame
6 months
Title
Medication Adherence
Description
Measured by the Morisky 8-item Medication Adherence scale.
Time Frame
6 months
Title
Quality of Life
Description
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.
Time Frame
6 months
Title
Health Resources and Services Administration (HRSA)
Description
Evaluate patient and provider satisfaction
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32734251
Citation
Johns TS, Brown DD, Litwin AH, Goldson G, Buttar RS, Kreimerman J, Lo Y, Reidy KJ, Bauman L, Kaskel F, Melamed ML. Group-Based Care in Adults and Adolescents With Hypertension and CKD: A Feasibility Study. Kidney Med. 2020 Apr 18;2(3):317-325. doi: 10.1016/j.xkme.2020.01.013. eCollection 2020 May-Jun.
Results Reference
derived
Learn more about this trial
Group-based Chronic Kidney Disease Care
We'll reach out to this number within 24 hrs