Cyclic Vomiting SyndromeNCT04329637
Effects of an Integrative Health Care Model With Meditation and Care Cordination in CVS
A study testing Integrative healt care in people with Cyclic Vomiting Syndrome, run by Medical College of Wisconsin.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cyclic Vomiting Syndrome
- What is being tested?
- Integrative healt care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2016to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects with CVS
Who cannot join
- 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.
About this study
Official title: An Integrative, Patient-Centered Model of Care: Meditation and Care Coordination to Improve Healthcare Outcomes in Cyclic Vomiting Syndrome
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.
Read the 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.
- Conditions
- Cyclic Vomiting Syndrome
- Being tested
- Integrative healt care
- Keywords
- cyclic vomiting; meditation; care coordination
- Medical subject headings
- Familial cyclic vomiting syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative healt careOther
Also called IHC
Meditation and use of a care cordinator
| Study group | Role | What they receive |
|---|---|---|
| IHC (intergrative health care) arm | Active comparator | Meditation and care coordination in addition to usual care Receives: Other: Integrative healt care |
| usual care | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start5 Oct 2016
- Primary completion5 Feb 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyclic Vomiting SyndromeStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thangam Venkatesan, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329637
- Sponsor's protocol ID
- PRO00027409
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrative, Patient-Centered Model of Care: Meditation and Care Coordination to Improve Healthcare Outcomes in Cyclic Vomiting Syndrome
- ClinicalTrials.gov ID
- NCT04329637
- Acronym / sponsor ID
- PRO00027409
- Conditions
- Cyclic Vomiting Syndrome
- Keywords
- cyclic vomiting; meditation; care coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| IHC (intergrative health care) arm | Active comparator | Other: Integrative healt careMeditation and care coordination in addition to usual care |
| usual care | No intervention | –usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects with CVS
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative healt careAlso: IHCMeditation and use of a care cordinator | Other | IHC (intergrative health care) arm |
Primary outcome
Levels of psychological distress is measured using a validated questionnaire called the Basic Symptom Inventory
Time frame: 6 months
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.
1 secondary outcome
Mutiple domains of coping will be measured by the COPE questionanire which is a validated tool
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: No
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A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative healt care in people with Cyclic Vomiting Syndrome, run by Medical College of Wisconsin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of psychological distress is measured using a validated questionnaire called the Basic Symptom Inventory (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.