Changing Results—Engage and Activate to Enhance Wellness: A Randomized Clinical Trial to Improve Cardiovascular Risk Management

Abstract

BackgroundDespite the success of current cardiovascular disease (CVD) management programs, many patients do not achieve optimal control of CVD‐related risk factors. New strategies are needed to better activate and engage these patients.Methods and ResultsWe conducted a parallel, 2‐arm, randomized controlled trial, CREATE Wellness (Changing Results—Engage and Activate to Enhance Wellness) from February 2015 to September 2017 with 12‐month follow‐up to September 2018. Eligible participants had ≥1 uncontrolled CVD risk factors (hyperlipidemia, hypertension, or diabetes mellitus) for at least 2 years before study enrollment. The control group (n=315) received usual care within an existing CVD population‐based disease management program. The intervention group (n=332) received usual care plus a group‐based behavioral intervention focused on patient activation and engagement. Study outcomes included patient activation and patient‐centered care processes (6 months) and healthcare system engagement, medication adherence, and control of CVD risk factors (12 months). Compared with the control group at follow‐up, the intervention group had greater improvement in patient activation (adjusted mean difference=2.8, P=0.01), patient‐centered care (adjusted mean difference=0.19, P=0.003), and 2 out of 3 measures of healthcare system engagement (eg, secure messages exchanged with a population health manager; adjusted incidence rate ratio=1.7, P=0.01). Intervention and control arms did not differ on improvement in 1‐year CVD risk factor control.ConclusionsFurther work is needed to more effectively connect increased patient activation and engagement to downstream changes in risk factor control.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02302612.

Patient-Centered Care for Patients with Cardiometabolic Diseases: An Integrative Review

“…A content analysis was performed based on the extracted indicators and a patientcentered intervention model was built (Figure 2). The intervention indicators extracted from the studies were: Behavioral interventions [15,21,24,25]; Therapeutic management programs [17,23,24]; Lifestyle promotion [11,13,14,24]; Shared decision making [12,14,16,18]; Education patient and information [15,21,22,24]; Interventions with the use of technology [11,17,25]; Program using technology [11,17,18,24,25]; Therapeutic relationship and communication [13,25]; Therapeutic adherence programs [16,21,23,25]; Caregiver engagement [12,22]; Promotion of self-management [15,21,25]; and Specialized intervention [18,22].…”

“…In the study by Dhukaram, Baber and De Stefanis (2012) [17], the evaluation was performed based on a focus group to understand the concerns and perceptions of patients. In a study con- The intervention indicators extracted from the studies were: Behavioral interventions [15,21,24,25]; Therapeutic management programs [17,23,24]; Lifestyle promotion [11,13,14,24]; Shared decision making [12,14,16,18]; Education patient and information [15,21,22,24]; Interventions with the use of technology [11,17,25]; Program using technology [11,17,18,24,25]; Therapeutic relationship and communication [13,25]; Therapeutic adherence programs [16,21,23,25]; Caregiver engagement [12,22]; Promotion of selfmanagement [15,21,25]; and Specialized intervention [18,22]. 2019 Randomized controlled trial CREATE Wellness was an intervention designed to develop knowledge and skills in patients systematically unable to achieve the therapeutic goals of management and control of CVD risk factors.…”

“…The planning of care and the respective intervention found in the selected studies revealed a diversity of data that mostly converge on care centered on patients and their individual conditions. The study conducted by Iturralde et al (2019) [11] designed an intervention to develop knowledge and skills in patients who were systematically unable to achieve therapeutic management goals and control cardiovascular risk factors. The e-health intervention for patient training and self-management was based on the use of voice or video calls to reinforce self-management behaviors and skills.…”

“…In general, the studies included in this integrative review show the following results: improvements in the care process, patient engagement [11], improvements in health status monitoring [17], improvements in communication between patient and health profes-sionals [12,13,17,18,22,25], improvements in shared decision making between patients and health professionals [14,16], data improvements, respecting data privacy and confidentiality [17], care continuity [22], and improved compliance with guidelines and accountability for health [13,14]. These results corroborate previous studies related to patient-and familycentered care with regard to improved knowledge, self-care management, medication adherence and patient satisfaction [3].…”

A randomized controlled trial of brain and heart health manager-led mHealth secondary stroke prevention

“…These present results are consistent with the results of previous studies. For example, an Ambulatory Blood Pressure Monitor Mobile Health System enabled a patient to be aware of their risks in real-time, which improved medication adherence with risk self-management, and the traditional telephone follow-up merely served as a reminder, with no specific intervention and lack of continuity (17). A number of studies have verified that the effectiveness of education gradually diminishes, in which medication compliance and self-management ability gradually declined with time (18).…”