Hypertension
Conditions
Keywords
high blood pressure, systolic, diastolic, complementary therapies, meditation
Brief summary
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
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.
Interventions
BEHAVIORALGOALS
16 weeks of online support to improve blood pressure using traditional behavioral lifestyle approaches and medication adherence support.
BEHAVIORALMinding GOALS
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic blood pressure and diastolic blood pressure (mm Hg) | Baseline, 4- and 12-months | Change in blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sodium excretion (mmol/24 hr.) | Baseline and 12-months | From 24-hr urine collection |
| 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 | Assessed by pedometer |
| Health-related quality of life | Baseline, 4- and 12-months | PROMIS (Patient Reported Outcomes Measurement Information System)-29 Profile v2.0 |
| Perceived Stress Scale | Baseline, 4- and 12-months | — |
| PROMIS-29 Profile v2.0 | Baseline, 4- and 12-months | Quality of Life |
| Mindful Attention Awareness Scale | 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 |
| Self-reported medication adherence questions | Baseline, 4- and 12-months | Self-reported scale to measure medication adherence |
| Credibility/Expectancy Questionnaire | Baseline, 4- and 12-months | For measuring treatment expectancy and rationale credibility in clinical trials |
Countries
United States
Outcome results
None listed