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The CREATE Wellness Study

NCT02302612 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 647

Last updated 2018-10-16

No results posted yet for this study

Summary

Cardiovascular disease (CVD) is the leading cause of death in the U.S. Efforts to improve CVD risk factors often fall short in complex patients with multiple co-morbid conditions, a growing, expensive, and high-risk segment of the U.S. population. The investigators are testing a multi-component behavioral intervention designed to help complex patients with CVD and other concurrent chronic conditions to become more effective agents of their own care.

Conditions

Interventions

BEHAVIORAL

CREATE Wellness

Patients allocated to the intervention arm will receive three group sessions with between visit contacts designed to increase activation and engagement with their care plans. They will also continue to be enrolled in the KP PHASE program

OTHER

Usual Care Control

Patients allocated to the control arm will continue to receive usual care, including disease management within the KP PHASE program.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Richard W Grant, MD MPH · Division of Research, KPNC

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02302612 on ClinicalTrials.gov