The CREATE Wellness Study
Multi-Component Behavioral Intervention for Complex Patients With CVD Risk. The Changing Results: Engage and Activate to Enhance Wellness (CREATE Wellness) Study
2 other identifiers
interventional
647
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Jan 2015
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2014
CompletedFirst Posted
Study publicly available on registry
November 27, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedOctober 16, 2018
October 1, 2018
3.7 years
November 21, 2014
October 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite CVD Goal
We will compare the proportion of patients in the two study arms who achieve all three clinical goals of the PHASE disease management program (blood pressure control, HbA1c control (if applicable), and statin prescription) 12 months after enrollment. Risk factor control is defined according to the PHASE disease management program protocol.
12-months
Secondary Outcomes (3)
Perceived efficacy in patient-physician interactions (PEPPI) - 10 items
6 months
Effective Consumer Scale (EC-17)
6 months
Patient Activation Measure (PAM) - 13 items
6 months
Study Arms (2)
CREATE Wellness
EXPERIMENTALPatients 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 disease management program.
Usual Care Control
ACTIVE COMPARATORPatients allocated to the control arm will continue to receive usual care, including disease management within the KP PHASE program.
Interventions
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
Patients allocated to the control arm will continue to receive usual care, including disease management within the KP PHASE program.
Eligibility Criteria
You may qualify if:
- Kaiser Permanente Northern California members enrolled in the PHASE disease management program and not meeting all goals of care for the preceding 2 years.
You may not qualify if:
- Schizophrenia or personality disorder
- Unable to communicate in English
- Unwilling to participate in group-based in-person program
- Pregnant
- Terminal or debilitating illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaiser Permanente San Jose Sabrina Wood, BA (510) 891-3551 Sabrina.B.Wood@kp.org
San Jose, California, 95119, United States
Related Publications (3)
Iturralde E, Sterling SA, Uratsu CS, Mishra P, Ross TB, Grant RW. Changing Results-Engage and Activate to Enhance Wellness: A Randomized Clinical Trial to Improve Cardiovascular Risk Management. J Am Heart Assoc. 2019 Dec 3;8(23):e014021. doi: 10.1161/JAHA.119.014021. Epub 2019 Nov 30.
PMID: 31787053DERIVEDTorres DX, Lu WY, Uratsu CS, Sterling SA, Grant RW. Knowing How to Ask Good Questions: Comparing Latinos and Non-Latino Whites Enrolled in a Cardiovascular Disease Prevention Study. Perm J. 2019;23:18-258. doi: 10.7812/TPP/18-258.
PMID: 30939290DERIVEDMiller-Rosales C, Sterling SA, Wood SB, Ross T, Makki M, Zamudio C, Kane IM, Richardson MC, Samayoa C, Charvat-Aguilar N, Lu WY, Vo M, Whelan K, Uratsu CS, Grant RW. CREATE Wellness: A multi-component behavioral intervention for patients not responding to traditional Cardiovascular disease management. Contemp Clin Trials Commun. 2017 Oct 4;8:140-146. doi: 10.1016/j.conctc.2017.10.001. eCollection 2017 Dec.
PMID: 29696203DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard W Grant, MD MPH
Division of Research, KPNC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2014
First Posted
November 27, 2014
Study Start
January 1, 2015
Primary Completion
September 30, 2018
Study Completion
September 30, 2018
Last Updated
October 16, 2018
Record last verified: 2018-10