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临床试验/NCT02694432
NCT02694432已完成不适用

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

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
Change in systolic blood pressure and diastolic blood pressure (mm Hg)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •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

研究组 & 干预措施

GOALS

Active Comparator

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.

干预措施: GOALS (Behavioral)

Minding GOALS

Experimental

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.

干预措施: GOALS (Behavioral)

Minding GOALS

Experimental

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.

干预措施: Minding GOALS (Behavioral)

结局指标

主要结局

Change in systolic blood pressure and diastolic blood pressure (mm Hg)

时间窗: Baseline, 4- and 12-months

Change in blood pressure

次要结局

  • Change in sodium excretion (mmol/24 hr.)(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)(Baseline, 4- and 12-months)
  • Health-related quality of life(Baseline, 4- and 12-months)
  • Perceived Stress Scale(Baseline, 4- and 12-months)
  • Mindful Attention Awareness Scale(Baseline, 4- and 12-months)
  • Credibility/Expectancy Questionnaire(Baseline, 4- and 12-months)
  • PROMIS-29 Profile v2.0(Baseline, 4- and 12-months)
  • Self-reported medication adherence questions(Baseline, 4- and 12-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Natalia Morone

Associate Professor of Medicine & Clinical and Translational Science

University of Pittsburgh

研究点 (1)

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