Ignite Creation Date:
2024-05-06 @ 2:28 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04329637
Status:
COMPLETED
Last Update Posted:
2020-04-01
First Post:
2020-03-26
Brief Title:
Effects of an Integrative Health Care Model With Meditation and Care Cordination in CVS
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
An Integrative Patient-Centered Model of Care Meditation and Care Coordination to Improve Healthcare Outcomes in Cyclic Vomiting Syndrome
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None