NCT02467894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

June 8, 2015

Last Update Submit

March 11, 2019

Conditions

Chronic Kidney DiseaseHypertension

Keywords

AdherenceExercise

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (4)

  • Accelerometer

    6 months

  • Medication Adherence

    6 months

  • Quality of Life

    6 months

  • +1 more other outcomes

Study Arms (2)

Group-based Care

EXPERIMENTAL

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.

Other: Group-based Care

Usual Care

NO INTERVENTION

Participants who are randomized to usual care will see their provider on clinic days when there is no group meeting.

Interventions

Group-based CareOTHER

There will be self-care activities, blood pressure measurements and other vitals, including discussion of specific topics initiated by the participants.

Group-based Care

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (1)

  • 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.

    PMID: 32734251DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicHypertensionMotor Activity

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Of Medicine & Epidemiology & Population Health

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 10, 2015

Study Start

August 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

US(1)