Center for Research on Health Care, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT02694432
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.
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Notify Me21 year–79 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15213, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
16 weeks of online support to improve blood pressure using traditional behavioral lifestyle approaches and medication adherence support.
16 weeks of online support to improve blood pressure using traditional behavioral lifestyle approaches and medication adherence support, coupled with a mind-body-behavior program to further enhance improvements in blood pressure.
Other names: Stress reduction
Time frame: Baseline, 4- and 12-months
Change in blood pressure
Time frame: Baseline and 12-months
From 24-hr urine collection
Time frame: Baseline, 4- and 12-months
Time frame: Baseline, 4- and 12-months
Time frame: Baseline, 4- and 12-months
Assessed by pedometer
Time frame: Baseline, 4- and 12-months
PROMIS (Patient Reported Outcomes Measurement Information System)-29 Profile v2.0
Time frame: Baseline, 4- and 12-months
Time frame: Baseline, 4- and 12-months
Quality of Life
Time frame: Baseline, 4- and 12-months
Assesses a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present
Time frame: Baseline, 4- and 12-months
Self-reported scale to measure medication adherence
Time frame: Baseline, 4- and 12-months
For measuring treatment expectancy and rationale credibility in clinical trials
University of Pittsburgh
Other
An Internet-Assisted Mind-Body-Behavior Program for Blood Pressure Control
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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