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Effects of an Integrative Health Care Model With Meditation and Care Cordination in CVS

Primary Purpose

Cyclic Vomiting Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Integrative healt care
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cyclic Vomiting Syndrome focused on measuring cyclic vomiting; meditation; care coordination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All subjects with CVS

Exclusion Criteria:

  • Severe cognitive impairment, active mental health problems such as suicidal ideation, severe anxiety or depression requiring inpatient care, or an inability to sit for at least 20 minutes. Subjects with severe cardiopulmonary diseases, malignancy, liver cirrhosis, renal failure on dialysis or those who were pregnant at the time of enrollment were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    IHC (intergrative health care) arm

    usual care

    Arm Description

    Meditation and care coordination in addition to usual care

    usual care

    Outcomes

    Primary Outcome Measures

    Levels of psychological distress is measured using a validated questionnaire called the Basic Symptom Inventory
    Basic symptom inventory The Brief Symptom Inventory (BSI) consists of 53 items covering nine symptom dimensions: Somatization, Obsession-Compulsion, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation and Psychoticism; and three global indices of distress: Global Severity Index, Positive Symptom Distress Index, and Positive Symptom Total. The global indices measure current or past level of symptomatology, intensity of symptoms, and number of reported symptoms, respectively.

    Secondary Outcome Measures

    Mutiple domains of coping will be measured by the COPE questionanire which is a validated tool
    COPE questionanire: The COPE questionnaire consists of the following. Five scales (of four items each) measure conceptually distinct aspects of problem-focused coping (active coping, planning, suppression of competing activities, restraint coping, seeking of instrumental social support); five scales measure aspects of what might be viewed as emotional-focused coping (seeking of emotional social support, positive reinterpretation, acceptance, denial, turning to religion); and three scales measure coping responses that arguably are less useful (focus on and venting of emotions, behavioral disengagement, mental disengagement).

    Full Information

    First Posted
    March 26, 2020
    Last Updated
    March 30, 2020
    Sponsor
    Medical College of Wisconsin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04329637
    Brief Title
    Effects of an Integrative Health Care Model With Meditation and Care Cordination in CVS
    Official Title
    An Integrative, Patient-Centered Model of Care: Meditation and Care Coordination to Improve Healthcare Outcomes in Cyclic Vomiting Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 5, 2016 (Actual)
    Primary Completion Date
    February 5, 2019 (Actual)
    Study Completion Date
    December 15, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical College of Wisconsin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Cyclic vomiting syndrome is a chronic functional gastrointestinal disorder that is a significant health care problem. It affects 1-2% of the population and imposes an enormous burden on patients, families and the health care system. Due to the recalcitrant nature of the disease, patients have high rates of health care utilization with multiple emergency department visits and hospitalizations. These in turn lead to school and work absenteeism, job loss, divorce and even disability. CVS is also associated with multiple comorbid conditions such as anxiety and depression, which further contribute to disease severity. Both neuroimaging studies and other data demonstrate the role of the central nervous system in the pathophysiology of CVS with stress being a significant trigger for episodes of CVS. In summary, CVS is common, disabling and expensive and is associated with significant psychosocial comorbidity that contributes to impaired quality of life . Our current healthcare delivery model is disease-centric and does not adequately address the psychosocial barriers that contribute to poor health in this patient population. We propose a novel, collaborative, integrative health care model that shifts the paradigm of care from one that is episodic and disease-centered to a patient-centered approach that addresses psychosocial determinants of health not addressed in our current traditional health care system. We will incorporate meditation practices that have been shown to reduce psychological distress and also add a care coordinator to our health care delivery team. The primary role of the care coordinator is to identify patient goals, preferences and barriers to self-management and address psychosocial and environmental issues that determine health. Patients will be randomized to either the integrative health care model or usual care. The primary aim of our study is to determine the impact of our proposed integrative health care model on health care outcomes which will include a reduction in psychological distress, improvement in coping skills for managing chronic disease, cognitive symptom management, improvement in health-related quality of life and reduction in health care utilization. This collaborative effort between physicians, community partners, and allied health personnel will redesign the health care delivery system, facilitate access to appropriate healthcare services, optimize chronic disease management and improve overall healthcare outcomes.
    Detailed Description
    Background & Aims: Cyclic vomiting syndrome (CVS) is associated with psychosocial comorbidity and often triggered by stress. The current disease-centered model of care does not address psychosocial factors that impact patient outcomes. The investigators hypothesized that a holistic, patient-centered care model integrating meditation and addressing psychosocial needs through a care coordinator, will improve healthcare outcomes in CVS. Methods: The investigators conducted a prospective randomized controlled trial of 49 patients with CVS (mean age: 34 ± 14 years; 81% female) who were randomized to conventional healthcare (control group) or Integrative Health Care (IHC) (27: control group, 22: IHC group;). In the IHC group, patients were assigned a care coordinator and received meditation sessions from certified trainers from the Heartfulness Institute. Outcomes including psychological distress, coping strategies to manage chronic stress, cognitive symptom management, and Health-Related Quality of Life were measured with validated tools. An intention-to-treat analysis was performed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cyclic Vomiting Syndrome
    Keywords
    cyclic vomiting; meditation; care coordination

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients were prospectively randomized to either the integrative health care model (IHC model) or usual care (UC)/control group after signing informed consent. Demographics, clinical characteristics and outcomes of interest were measured at baseline before the intervention, and at 3 and 6 months. Global psychological distress ,depression, catastrophizing, anxiety/pain-related fear, and social support were assessed using validated tools. Coping skills were measured with the validated short version of the COPE questionnaire. Quality of sleep was assessed using Pittsburgh Sleep Quality Index (PSQI). HRQoL was measured with the NIH PROMIS Short Forms. Health care utilization was recorded.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    74 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IHC (intergrative health care) arm
    Arm Type
    Active Comparator
    Arm Description
    Meditation and care coordination in addition to usual care
    Arm Title
    usual care
    Arm Type
    No Intervention
    Arm Description
    usual care
    Intervention Type
    Other
    Intervention Name(s)
    Integrative healt care
    Other Intervention Name(s)
    IHC
    Intervention Description
    Meditation and use of a care cordinator
    Primary Outcome Measure Information:
    Title
    Levels of psychological distress is measured using a validated questionnaire called the Basic Symptom Inventory
    Description
    Basic symptom inventory The Brief Symptom Inventory (BSI) consists of 53 items covering nine symptom dimensions: Somatization, Obsession-Compulsion, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation and Psychoticism; and three global indices of distress: Global Severity Index, Positive Symptom Distress Index, and Positive Symptom Total. The global indices measure current or past level of symptomatology, intensity of symptoms, and number of reported symptoms, respectively.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Mutiple domains of coping will be measured by the COPE questionanire which is a validated tool
    Description
    COPE questionanire: The COPE questionnaire consists of the following. Five scales (of four items each) measure conceptually distinct aspects of problem-focused coping (active coping, planning, suppression of competing activities, restraint coping, seeking of instrumental social support); five scales measure aspects of what might be viewed as emotional-focused coping (seeking of emotional social support, positive reinterpretation, acceptance, denial, turning to religion); and three scales measure coping responses that arguably are less useful (focus on and venting of emotions, behavioral disengagement, mental disengagement).
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All subjects with CVS Exclusion Criteria: Severe cognitive impairment, active mental health problems such as suicidal ideation, severe anxiety or depression requiring inpatient care, or an inability to sit for at least 20 minutes. Subjects with severe cardiopulmonary diseases, malignancy, liver cirrhosis, renal failure on dialysis or those who were pregnant at the time of enrollment were excluded.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of an Integrative Health Care Model With Meditation and Care Cordination in CVS

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