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

3. juli 2018 opdateret af: Natalia Morone, University of Pittsburgh

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

76

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Center for Research on Health Care, University of Pittsburgh

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 79 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: GOALS
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.
16 weeks of online support to improve blood pressure using traditional behavioral lifestyle approaches and medication adherence support.
Eksperimentel: Minding GOALS
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.
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.
Andre navne:
  • Stress reduction

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in systolic blood pressure and diastolic blood pressure (mm Hg)
Tidsramme: Baseline, 4- and 12-months
Change in blood pressure
Baseline, 4- and 12-months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in sodium excretion (mmol/24 hr.)
Tidsramme: Baseline and 12-months
From 24-hr urine collection
Baseline and 12-months
Body weight (kg)
Tidsramme: Baseline, 4- and 12-months
Baseline, 4- and 12-months
Body Mass Index (kg/m2)
Tidsramme: Baseline, 4- and 12-months
Baseline, 4- and 12-months
Physical activity (steps/day)
Tidsramme: Baseline, 4- and 12-months
Assessed by pedometer
Baseline, 4- and 12-months
Health-related quality of life
Tidsramme: Baseline, 4- and 12-months
PROMIS (Patient Reported Outcomes Measurement Information System)-29 Profile v2.0
Baseline, 4- and 12-months
Perceived Stress Scale
Tidsramme: Baseline, 4- and 12-months
Baseline, 4- and 12-months
PROMIS-29 Profile v2.0
Tidsramme: Baseline, 4- and 12-months
Quality of Life
Baseline, 4- and 12-months
Mindful Attention Awareness Scale
Tidsramme: 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
Baseline, 4- and 12-months
Self-reported medication adherence questions
Tidsramme: Baseline, 4- and 12-months
Self-reported scale to measure medication adherence
Baseline, 4- and 12-months
Credibility/Expectancy Questionnaire
Tidsramme: Baseline, 4- and 12-months
For measuring treatment expectancy and rationale credibility in clinical trials
Baseline, 4- and 12-months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Natalia Morone, MD, MS, University of Pittsburgh
  • Ledende efterforsker: Kathleen M McTigue, MD, MS, MPH, University of Pittsburgh

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2016

Primær færdiggørelse (Faktiske)

31. marts 2018

Studieafslutning (Faktiske)

31. marts 2018

Datoer for studieregistrering

Først indsendt

12. januar 2016

Først indsendt, der opfyldte QC-kriterier

23. februar 2016

Først opslået (Skøn)

29. februar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PRO15120045
  • R34HL123500-01 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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