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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: GOALS
* Behavioral: Minding GOALS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GOALS<br>Participants will use for approximately four months an online platform, GOALS, consisting of weekly lessons designed to enhance blood pressure control. Recommended lifestyle changes for hypertension, including a low-sodium diet, physical activity, weight loss (if appropriate) and behavioral self-management skills will be offered. Attention to medication adherence and pharmacist support as well as that of a dedicated online health coach and ongoing collaboration with the primary care physician are also provided. | Behavioral: GOALS<br>* 16 weeks of online support to improve blood pressure using traditional behavioral lifestyle approaches and medication adherence support.<br>|
| Experimental: Minding GOALS<br>Participants in this arm will also use the GOALS standard tools for blood pressure control. To further maximize success, they will receive additional online behavioral training throughout the 4-month intervention that focuses on mind-body approaches. Weekly topics, for example, will include meditation lessons, mindfulness-based stress reduction and mindfulness-based eating awareness. | Behavioral: GOALS<br>* 16 weeks of online support to improve blood pressure using traditional behavioral lifestyle approaches and medication adherence support.<br>Behavioral: Minding GOALS<br>* 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.<br>* Other names: Stress reduction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure and diastolic blood pressure (mm Hg) | Change in blood pressure | Baseline, 4- and 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sodium excretion (mmol/24 hr.) | From 24-hr urine collection | Baseline and 12-months | 
| Body weight (kg) |  | Baseline, 4- and 12-months | 
| Body Mass Index (kg/m2) |  | Baseline, 4- and 12-months | 
| Physical activity (steps/day) | Assessed by pedometer | Baseline, 4- and 12-months | 
| Health-related quality of life | PROMIS (Patient Reported Outcomes Measurement Information System)-29 Profile v2.0 | Baseline, 4- and 12-months | 
| Perceived Stress Scale |  | Baseline, 4- and 12-months | 
| PROMIS-29 Profile v2.0 | Quality of Life | Baseline, 4- and 12-months | 
| Mindful Attention Awareness Scale | Assesses a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present | Baseline, 4- and 12-months | 
| Self-reported medication adherence questions | Self-reported scale to measure medication adherence | Baseline, 4- and 12-months | 
| Credibility/Expectancy Questionnaire | For measuring treatment expectancy and rationale credibility in clinical trials | Baseline, 4- and 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high blood pressure, systolic, diastolic, complementary therapies, meditation