DiabetesNCT02302612
The CREATE Wellness Study
A study testing CREATE Wellness in people with Diabetes and Heart Disease, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Diabetes, Heart Disease, Hypertension
- What is being tested?
- CREATE Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 647 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kaiser Permanente Northern California members enrolled in the PHASE disease management program and not meeting all goals of care for the preceding 2 years.
Who cannot join
- Schizophrenia or personality disorder
- Unable to communicate in English
- Unwilling to participate in group-based in-person program
- Pregnant
- Terminal or debilitating illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente San Jose Sabrina Wood, BA (510) 891-3551 Sabrina.B.Wood@kp.org
San Jose, California, 95119
About this study
Official title: Multi-Component Behavioral Intervention for Complex Patients With CVD Risk. The Changing Results: Engage and Activate to Enhance Wellness (CREATE Wellness) Study
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.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of death in the U.S. Despite the availability of evidence-based guidelines and efficacious therapies, however, many patients do not achieve the full benefit of CVD risk reduction. In particular, complex patients (defined as those patients who do not respond to current disease management approaches) with multiple concurrent chronic conditions represent a key segment of the population that would benefit from new approaches to care. In response to PA-12-024: Behavioral Interventions to Address Multiple Chronic Conditions in Primary Care, which seeks "practical interventions…to modify behaviors using a common approach" among patients with multiple co-morbidities, the investigators are testing an integrated behavioral intervention designed to improve a core set of chronic disease self-management skills and to overcome common barriers to care engagement encountered by this increasingly important segment of the U.S. adult primary care population. This randomized trial will be conducted within Kaiser Permanente Northern California (KPNC), an integrated care delivery system serving over 3.2 million members, including patients insured through Medicare and state Medicaid programs. The investigators will evaluate the intervention in 3 KPNC primary care practices by enrolling 576 complex patients who have persistently (≥ 2 years) uncontrolled CVD risk factors (e.g. hypertension, hyperlipidemia, diabetes) despite being enrolled in a CVD disease management program. This behavioral intervention is designed to activate and engage patients, identify potentially hidden barriers to care such as alcohol misuse or sub-clinical depression, and to develop individualized care plans that are designed to catalyze more effective primary care management. Randomization will be at the patient-level. The investigators will examine the impact of the intervention on clinical outcomes (control of systolic blood pressure, HbA1c (if with diabetes), statin treatment rates) after 12 months and patient-reported outcomes (patient activation, medication adherence, and mental health status) after 6 months. By focusing on core health skills and care barriers, this patient-focused intervention seeks to enable complex patients to become more effective agents of their own care and to thereby achieve similar clinical benefits as less complex patients.
- Conditions
- Diabetes, Heart Disease, Hypertension, Dyslipidemia
- Being tested
- CREATE Wellness, Usual Care Control
- Keywords
- chronic conditions, complex patients, engagement, activation
- Medical subject headings
- Diabetes Mellitus, Heart Diseases, Hypertension, Dyslipidemias, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CREATE WellnessBehavioural
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
Usual Care ControlOther
Patients allocated to the control arm will continue to receive usual care, including disease management within the KP PHASE program.
| Study group | Role | What they receive |
|---|---|---|
| CREATE Wellness | Experimental | 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 disease management program. Receives: Behavioral: CREATE Wellness |
| Usual Care Control | Active comparator | Patients allocated to the control arm will continue to receive usual care, including disease management within the KP PHASE program. Receives: Other: Usual Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-months
Secondary outcomes (3)
Perceived efficacy in patient-physician interactions (PEPPI) - 10 items
We will compare proportion of patients with improvement between baseline and follow-up PEPPI 10-item survey scores between study arms
Measured: 6 months
Effective Consumer Scale (EC-17)
We will compare proportion of patients with improvement between baseline and follow-up EC-17 scores between study arms
Measured: 6 months
Patient Activation Measure (PAM) - 13 items
We will compare proportion of patients with improvement between baseline and follow-up PAM scores between study arms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startJan 2015
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Richard W Grant, MD MPH, Principal investigator, Division of Research, KPNC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302612
- Sponsor's protocol ID
- CN-13-1672-H
- Other IDs
- R01HL117939
- Status last verified
- Oct 2018
- First submitted
- 21 Nov 2014
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31787053Torres 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.
PubMed 30939290Miller-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.
PubMed 29696203
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Component Behavioral Intervention for Complex Patients With CVD Risk. The Changing Results: Engage and Activate to Enhance Wellness (CREATE Wellness) Study
- ClinicalTrials.gov ID
- NCT02302612
- Acronym / sponsor ID
- CN-13-1672-H
- Conditions
- Diabetes, Heart Disease, Hypertension, Dyslipidemia
- Keywords
- chronic conditions, complex patients, engagement, activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2015
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular disease (CVD) is the leading cause of death in the U.S. Despite the availability of evidence-based guidelines and efficacious therapies, however, many patients do not achieve the full benefit of CVD risk reduction. In particular, complex patients (defined as those patients who do not respond to current disease management approaches) with multiple concurrent chronic conditions represent a key segment of the population that would benefit from new approaches to care. In response to PA-12-024: Behavioral Interventions to Address Multiple Chronic Conditions in Primary Care, which seeks "practical interventions…to modify behaviors using a common approach" among patients with multiple co-morbidities, the investigators are testing an integrated behavioral intervention designed to improve a core set of chronic disease self-management skills and to overcome common barriers to care engagement encountered by this increasingly important segment of the U.S. adult primary care population. This randomized trial will be conducted within Kaiser Permanente Northern California (KPNC), an integrated care delivery system serving over 3.2 million members, including patients insured through Medicare and state Medicaid programs. The investigators will evaluate the intervention in 3 KPNC primary care practices by enrolling 576 complex patients who have persistently (≥ 2 years) uncontrolled CVD risk factors (e.g. hypertension, hyperlipidemia, diabetes) despite being enrolled in a CVD disease management program. This behavioral intervention is designed to activate and engage patients, identify potentially hidden barriers to care such as alcohol misuse or sub-clinical depression, and to develop individualized care plans that are designed to catalyze more effective primary care management. Randomization will be at the patient-level. The investigators will examine the impact of the intervention on clinical outcomes (control of systolic blood pressure, HbA1c (if with diabetes), statin treatment rates) after 12 months and patient-reported outcomes (patient activation, medication adherence, and mental health status) after 6 months. By focusing on core health skills and care barriers, this patient-focused intervention seeks to enable complex patients to become more effective agents of their own care and to thereby achieve similar clinical benefits as less complex patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CREATE Wellness | Experimental | Behavioral: CREATE WellnessPatients 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 comparator | Other: Usual Care ControlPatients allocated to the control arm will continue to receive usual care, including disease management within the KP PHASE program. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Kaiser Permanente Northern California members enrolled in the PHASE disease management program and not meeting all goals of care for the preceding 2 years.
Key exclusion criteria (5 listed)
- Schizophrenia or personality disorder
- Unable to communicate in English
- Unwilling to participate in group-based in-person program
- Pregnant
- Terminal or debilitating illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CREATE WellnessPatients 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 | Behavioural | CREATE Wellness |
| Usual Care ControlPatients allocated to the control arm will continue to receive usual care, including disease management within the KP PHASE program. | Other | Usual Care Control |
Primary outcome
Composite CVD Goal
Time frame: 12-months
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.
3 secondary outcomes
Perceived efficacy in patient-physician interactions (PEPPI) - 10 items
Time frame: 6 months
Effective Consumer Scale (EC-17)
Time frame: 6 months
Patient Activation Measure (PAM) - 13 items
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Derived from this study: PubMed 31787053Iturralde 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.
- Derived from this study: PubMed 30939290Torres 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.
- Derived from this study: PubMed 29696203Miller-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard W Grant, MD MPH principal investigator
Division of Research, KPNC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CREATE Wellness in people with Diabetes and Heart Disease, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite CVD Goal (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302612, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.