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

NCT04329637 | Completed

• 1 other identifier: PRO00027409
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cyclic Vomiting Syndrome

Keywords

cyclic vomiting; meditation; care coordination

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Mutiple domains of coping will be measured by the COPE questionanire which is a validated tool

  6 months

Study Arms (2)

IHC (intergrative health care) arm

ACTIVE COMPARATOR

Meditation and care coordination in addition to usual care

Other: Integrative healt care

usual care

NO INTERVENTION

usual care

Interventions

Integrative healt care OTHER

Meditation and use of a care cordinator

Also known as: IHC

IHC (intergrative health care) arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects with CVS

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

MeSH Terms

Conditions

Familial cyclic vomiting syndrome

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 1, 2020
• Study Start: October 5, 2016
• Primary Completion: February 5, 2019
• Study Completion: December 15, 2019
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share