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Pilot 3

 
 

Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) Using Weight Management (MOMENTUM)


Susan Barnason, PhD, RN

Susan Barnason, PhD, RN

Principal Investigator

ABSTRACT

Obesity is an independent risk factor for coronary disease and is prevalent among patients who undergo cardiac revascularization; both percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABS).  The significance of cardiac disease is often underestimated by patients who undergo cardiac revascularization, and therefore they are more reticent in modifying their cardiac risk factors such as obesity following cardiac revascularization.  This issue is particularly problematic for rural populations, given that weight reduction specific programs are often not available in rural communities.  The overall goal of this pilot study is to evaluate a 12 week cognitive behavioral intervention for weight reduction of overweight or obese cardiac revascularization patients who participate in a rural cardiac rehabilitation program. The Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Surgery (CABS) Using Weight Management (MOMENTUM) intervention is comprised of 6 modules, totaling 34 telehealth sessions promoting weight reduction, and 2 telephone coaching sessions over the duration of the 12 week MOMENTUM intervention. The MOMENTUM intervention will be delivered using telehealth methods (Viterion telehealth device will be used to deliver the module content and the telephone to deliver the coaching sessions).  The intervention was purposively designed to overcome access barriers by using delivery modes accessible to patients in rural settings, in their home and at times convenient to their schedule.  A randomized, 2-group, repeated measures experimental design will be used.  Subjects who have had cardiac revascularization and are overweight or obese and enroll in a rural cardiac rehabilitation program will be randomized to either the MOMENTUM group (n=25) and or control group (usual care)(n=25).  The primary aim of the study is to compare the differences between the groups on weight reduction (primary outcome), diet behavior and physical activity (secondary outcomes) over time (baseline, 16 weeks, and 6 months after cardiac revascularization).   The second aim of the study is to to evaluate the feasibility of implementing the MOMENTUM intervention for a larger randomized controlled trial.   The innovation in this pilot study is the use of technology to deliver a comprehensive cognitive-behavioral weight reduction program to those cardiac patients in rural communities who otherwise might not have access to specific weight reduction programs to improve their cardiac risk profile after an acute cardiac event, such as a PCI or CABS.       

Purpose of the Study

The purpose of this pilot study is to evaluate a 12 week cognitive behavioral telehealth intervention for weight reduction framed within the Health Promotion Model (HPM) in overweight or obese cardiac revascularization (PCI or CABS) patients who participate in a rural CR program on the primary outcomes (weight reduction) and secondary outcomes (diet, physical activity and waist circumference) compared to those PCI or CABS subjects in a control group (usual care).  The study will address the following two aims of overweight and obese PCI or CABS patients in rural CR programs:

1. Compare the differences between the MOMENTUM intervention and control group (usual care) on the following outcomes over time (baseline, 16 weeks and 6 months after PCI or CABS):

Primary Outcome:

a. Weight reduction

      1) percent (%) of change in weight (compared to baseline); and

      2) proportion of subjects able to attain > 5% weight loss (compared to baseline).

Secondary Outcomes:

a. Diet behavior (% of target goal for total kcals measured by 3-day diet record);

b. Physical Activity behavior [average total activity counts per day and time (in minutes) spent in moderate and vigorous intensity physical activity as measured by the ActiGraph]; and

c. Abdominal fat content percent (%) change (compared to baseline) (Abnormal fat content based on Waist Circumference > 40 inches for males and > 35 inches for females)

2.  Evaluate MOMENTUM intervention for a larger randomized controlled trial (RCT).

a. Intervention mechanisms: Patient Activation (measured by Patient Activation Measure) and Goal Setting for weight reduction (Goal Attainment Scale)

b. Feasibility of MOMENTUM intervention: (1) Treatment delivered (number of intervention sessions delivered and number of strategies given); (2) Treatment receipt (the number of intervention sessions accessed and length of time for each session) (3) Treatment enactment (reported perception of usefulness of the strategies) and participant satisfaction with intervention (satisfaction with the mode of delivery, satisfaction with content of intervention, satisfaction with helpfulness of sessions—both telehealth sessions and virtual coaching).  

COMMON MEASURES: 

Demographic and Rural Variables Tool

Behavioral Risk Factor Surveillance System Questionnaire-Physical Activity

 Actigraph Accelerometer

 EQ-5D (Euro-Qol Group measure of health status) 

Consultants

Cyrus Desouza, MBBS, UNMC-COM      cdesouza@unmc.edu

Lani Zimmerman, PhD, RN, FAAN, UNMC-CON     lzimmerm@unmc.edu