Clinical trial NCT02694432: Minding GOALS: An Internet-Assisted Mind-Body-Behavior Program for Blood Pressure Control
Official title: An Internet-Assisted Mind-Body-Behavior Program for Blood Pressure Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: high blood pressure, systolic, diastolic
complementary therapies, meditation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-02-29
Enrollment: 76
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in systolic blood pressure and diastolic blood pressure (mm Hg)
timeFrame: Baseline, 4- and 12-months
Secondary outcomes:
measure: Change in sodium excretion (mmol/24 hr.)
timeFrame: Baseline and 12-months
measure: Body weight (kg)
timeFrame: Baseline, 4- and 12-months
measure: Body Mass Index (kg/m2)
timeFrame: Baseline, 4- and 12-months
measure: Physical activity (steps/day)
timeFrame: Baseline, 4- and 12-months
measure: Health-related quality of life
timeFrame: Baseline, 4- and 12-months
measure: Perceived Stress Scale
timeFrame: Baseline, 4- and 12-months
measure: PROMIS-29 Profile v2.0
timeFrame: Baseline, 4- and 12-months
measure: Mindful Attention Awareness Scale
timeFrame: Baseline, 4- and 12-months
measure: Self-reported medication adherence questions
timeFrame: Baseline, 4- and 12-months
measure: Credibility/Expectancy Questionnaire
timeFrame: Baseline, 4- and 12-months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Center for Research on Health Care, University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Natalia Morone, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Kathleen M McTigue, MD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: McTigue KM, Conroy MB, Hess R, Bryce CL, Fiorillo AB, Fischer GS, Milas NC, Simkin-Silverman LR. Using the internet to translate an evidence-based lifestyle intervention into practice. Telemed J E Health. 2009 Nov;15(9):851-8. doi: 10.1089/tmj.2009.0036.
citation: McTigue KM, Bhargava T, Bryce CL, Conroy M, Fischer GS, Hess R, Simkin-Silverman LR, Zickmund S. Patient perspectives on the integration of an intensive online behavioral weight loss intervention into primary care. Patient Educ Couns. 2011 May;83(2):261-4. doi: 10.1016/j.pec.2010.05.009. Epub 2010 Jun 17.
citation: McTigue KM, Conroy MB. Use of the internet in the treatment of obesity and prevention of type 2 diabetes in primary care. Proc Nutr Soc. 2013 Feb;72(1):98-108. doi: 10.1017/S0029665112002777. Epub 2012 Oct 26.
citation: Morone NE, Greco CM, Weiner DK. Mindfulness meditation for the treatment of chronic low back pain in older adults: a randomized controlled pilot study. Pain. 2008 Feb;134(3):310-319. doi: 10.1016/j.pain.2007.04.038. Epub 2007 Jun 1.
citation: Morone NE, Lynch CS, Greco CM, Tindle HA, Weiner DK. "I felt like a new person." the effects of mindfulness meditation on older adults with chronic pain: qualitative narrative analysis of diary entries. J Pain. 2008 Sep;9(9):841-8. doi: 10.1016/j.jpain.2008.04.003. Epub 2008 Jun 12.
citation: Simkin-Silverman LR, Conroy MB, Bhargava T, McTigue KM. Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. Diabetes Educ. 2011 Mar-Apr;37(2):263-8. doi: 10.1177/0145721710396587.
citation: Morone NE, Greco CM, Rollman BL, Moore CG, Lane B, Morrow L, Glynn NW, Delaney J, Albert SM, Weiner DK. The design and methods of the aging successfully with pain study. Contemp Clin Trials. 2012 Mar;33(2):417-25. doi: 10.1016/j.cct.2011.11.012. Epub 2011 Nov 15.