Minding GOALS: An Internet-Assisted Mind-Body-Behavior Program for Blood Pressure Control



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 79
Updated:7/8/2018
Start Date:September 2016
End Date:March 31, 2018

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An Internet-Assisted Mind-Body-Behavior Program for Blood Pressure Control

This pilot study will evaluate the feasibility of adding an online mind-body-behavior program
to an existing behavioral self-management support platform that has been modified to promote
achievement of blood pressure goals.

Efficacious hypertension therapies are well-documented, yet 40% of treated patients do not
meet the blood pressure goals set by the Joint National Committee. This gap between
scientific evidence and clinical outcomes in part reflects low patient adherence to lifestyle
recommendations (e.g., physical activity, weight and diet), as well as medication
non-adherence. Accordingly, growing attention is focused on the need to provide patients with
effective self-management support tools. In addition to finding ways to help patients adhere
to currently prescribed hypertension care, it is useful to consider the range of treatment
options that are offered. Evidence-based reviews have identified stress reduction as an
effective tool for reducing blood pressure, yet such approaches are typically not implemented
in practice. This omission represents a chance to improve the quality of hypertension care by
adding stress management self-management tools. Furthermore, since patients have demonstrated
a clear interest in mindfulness, the incorporation of a holistic mind-body intervention is an
innovative approach to inherently patient-centered care. Increasing data supports the use of
mindfulness for treating health concerns. Its holistic nature may be particularly well-suited
to developing and maintaining healthy lifestyles, since lifestyle impacts diverse aspects of
physical and psychological health. Yet the potential for mindfulness in health
self-management has not been realized.

Limited but promising data demonstrate the effectiveness of web-based counseling for behavior
modification to improve common chronic disease risk factors. It is an ideal solution to
provider time constraints and a potential solution to patient non-adherence to lifestyle
recommendations. Health information technology provides a way to make self-management support
affordable, convenient and feasible. The investigators have developed a convenient behavioral
self-management support platform, "Goal‐oriented Online Access to Lifestyle Support" (GOALS)
for primary care patients, which has promoted weight loss and improved blood pressure control
among primary care patients with weight-related cardiovascular risk factors. To maximize the
ability of patients to achieve blood pressure goals, the investigators propose to add an
online mind-body-behavior program to GOALS: "Minding GOALS." The investigators will evaluate
the feasibility of using this program for self-management support, in coordination with
primary care, in a group of 76 patients with uncontrolled hypertension. In preparation for a
randomized clinical trial comparing the online tool to online traditional self-management
support, the investigators will assess implementation and determine 1) the availability of
eligible and willing subjects using the proposed recruitment methods, 2) the feasibility of
delivering the proposed interventions in the population of interest, and 3) the viability of
the proposed measurement protocols.

Inclusion Criteria:

- Systolic blood pressure >/= 150 mmHg and/or

- Diastolic blood pressure >/= 90 mmHg and

- At least one other cardiovascular disease (CVD) risk factor (i.e., diabetes,
dyslipidemia, family history of premature CVD, current smoking, obesity)

Exclusion Criteria:

- Known secondary hypertension of any etiology, malignant hypertension or hypertensive
encephalopathy

- Severe edema

- A primary care physician (PCP) of the opinion that the patient is unable to safely
undertake moderately intense unsupervised physical activity (equivalent of 30 minutes
brisk walking)

- A PCP of the opinion that the patient has inadequate cognitive function to participate

- Previous participation in a mindfulness meditation program

- An inability to learn adequately from English language materials

- Current pregnancy or planned pregnancy within the next year

- A prior diagnosis of post-traumatic stress disorder

- Prior use of GOALS
We found this trial at
1
site
200 Lothrop Street
Pittsburgh, Pennsylvania 15213
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mi
from
Pittsburgh, PA
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