- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03673852
Peer Wellness Enhancement For Patients With Serious Mental Illness and High Medical Costs
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06511
- CT Mental Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants must be CMHC enrolled patients in the Behavioral Health Homes Program over the age of 18 years old
Exclusion Criteria:
- Participants who are not CMHC enrolled patients in the Behavioral Health Homes Program and under the age of 18 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Peer Wellness Enhancement (WE Harambee)
This project employs a pragmatic, stepped wedge experimental design in which 60 BHH participants are randomly assigned to one of 3 waves of WE Harambee implementation (20 in each wave) during the 2 year study.
Participants in this arm receive the WE Harambee Wellness Enhancement and are enrolled in a Behavioral Health Home.
WE Harambee is a 6-month peer-delivered whole health intervention intended to address the 8 dimensions of wellness and the social determinants of health.
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WE Harambee is a 6-month intervention, comprised of twice a week group meetings for 12 weeks, followed by a second 12 weeks of individual peer coaching/navigation.
WE Harambee aims to enhance access to and engagement in primary care and behavioral health services, as well as improve overall health and well-being, including the 8 dimensions of wellness and social determinants of health.
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Other: Behavioral Health Home enrollment
In the stepped wedge experimental design, 40 participants at any time during the 2 year study are receiving only the Behavioral Health Home (BHH) intervention.
The 2010 Patient Protection and Affordable Care Act (ACA) established a "health home" option under Medicaid that serves enrollees with chronic conditions including serious mental illness and chronic physical illness.
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A BHH is a Center for Medicaid Services program supporting Medicaid beneficiaries with complex needs, typically multiple chronic conditions impacting both physical and behavioral health.
Utilizing a team-based clinical approach that includes the patient, his/her providers, and possibly family members, BHH programs target service fragmentation by linking community supports and resources as well as by enhancing the integration of primary and behavioral health care.
Care Coordinators oversee and facilitate access to all services an individual needs to stay as healthy as possible, aiming to promote continuous health management not mere resolution of repeated acute episodes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported coping and problem solving
Time Frame: 21 months
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Coping and problem solving will be measured by the Health Problem-Solving Scale (HPSS).
The HPSS assesses effective and ineffective approaches to managing health-related problems.
It has been used with diverse samples, including with samples from HIV and DM.
Internal reliability coefficients were comparable in the two samples (HIV and Diabetes) and were within an acceptable psychometric range 0.63-0.88.
Scale items range from 0 (not at all true for me) to 4 (extremely true of me).
Higher scores indicate greater health problem solving.
The total score will be represented by a mean value so the range of the total score is also 0-4.
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21 months
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Self-reported self-efficacy
Time Frame: 21 months
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Self-efficacy will be measured by the Self-Efficacy for Chronic Illness Management scale, a 6-item measure that assesses confidence in one's ability to manage \ symptoms, function emotionally and instrumentally, and communicate effectively with physicians.
Internal consistency is reported to be .91.
Scale items range from 1 (not at all confident) to 10 (totally confident).
Higher scores indicate greater reported self-efficacy in managing one's chronic illness.
The total score will be represented by a mean value so the range of the total score is also 0-10.
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21 months
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Self-reported hope
Time Frame: 21 months
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Hope will be measured by the Hope Scale, a 12-item measure that assesses a) agency (goal-directed determination) and b) pathways (planning ways to meet goals).
Item ratings range from 1 (definitely false) to 8 (definitely true) with higher scores indicating more hope.
Subscales and total scores will be represented by means so the range is also 1 to 8.
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21 months
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Self-reported social support
Time Frame: 21 months
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Social support will be assessed using the Interpersonal Support Evaluation List (ISEL).
This 40-item instrument measures perceived availability of four types of support-tangible support, appraisal support, self-esteem support, and belonging support.
Item ratings are 0 (false) or 1 (true), with higher scores indicating more social support.
Subscales and total scores will be represented by means, accounting for missing data, so the range is also 0 to 1.
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21 months
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Self-reported sense of community
Time Frame: 21 months
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Sense of community will be measured by the Community Connections Index, a 15-item measure grounded in social capital and community capacity theories organized into two dimensions of community connections - Community engagement (8 items) and Sense of community (7 items).
Item ratings range from 1 (never) to 4 (often), with higher scores indicating more community connection.
The total score will be represented by a mean value so the range is also 0 to 4.
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21 months
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Self-reported empowerment
Time Frame: 21 months
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Empowerment will be measured the Empowerment Scale, which measures the construct of personal empowerment from the person's perspective.
Internal consistency for the Empowerment scale as a whole has been reported, with Cronbach's alpha coefficients = 0.86 will be used to measure empowerment.
Subscales include self-esteem/self-efficacy, power, community activism and autonomy, optimism and control over the future, and righteous anger.
Item responses range from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating more empowerment.
Subscales and total scores will be represented by a mean value, accounting for missing data, so their range is also 1-4.
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21 months
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Self-reported patient activation
Time Frame: 21 months
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Patient activation will be assessed via the Short Form version of the Patient Activation Measure (13 items).
Cronbach's alpha = -.83.
Item ratings range from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating more activation.
The total score will be represented by a mean value accounting for missing data, so the range is also 1-5.
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21 months
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Self-reported health literacy
Time Frame: 21 months
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Health Literacy will be measured by the reading comprehension section of the Short-Test of Functional Health Literacy (S-TOFHLA), which was designed to measure the ability to read and understand things patients commonly encounter in the healthcare setting.
The reading comprehension section asks respondents to read two passages about medical care and answer 20 questions in which they choose the correct missing word(s) from the sentences.
Total scores range from 0-100, with 5 points given for each question correctly answered.
Scores from 0-50 indicate inadequate health literacy, scores from 51-65 indicate marginal health literacy, and scores from 66-100 indicate adequate health literacy.
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21 months
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Self-reported barriers and facilitators to healthcare
Time Frame: 21 months
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Barriers and Facilitators of Healthcare will be assessed via the Peer Health Navigator Toolbox Barriers and Facilitators Measure.
Internal consistency is estimated at .69.
Scores range from 2 (major barrier) to 0 (not at all a barrier); 2 (helps a lot) to 0 (does not help), with higher scores indicating greater barrier or facilitator.
Individual barriers and facilitators will be analyzed separately.
Also, separate scores will be calculated for total barriers and total facilitators as mean scores, accounting for missing data, and will range from 0 to 2.
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21 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported illness self management
Time Frame: 21 months
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Illness self-management will be assessed using the Coping and Stress Reduction subscales of the Strategies Used by People to Promote Health (SUPPH-29).
The scale was designed specifically for people with chronic conditions, and has been used with cancer patients, patients with end stage renal disease, stroke survivors, and women with AIDS.
The measure asks about how confident a person is in using different techniques to reduce stress and cope with their illness.
Item ratings range from 1 (very little confidence) to 5 (quite a lot of confidence), with higher scores indicating more confidence.
Subscale scores and total scores will be represented by mean scores, accounting for missing data, and will also range from 1 to 5.
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21 months
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Self-reported engagement in healthcare
Time Frame: 21 months
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Engagement in healthcare will be assessed via the Patient Health Engagement Measure.
Items ask about how emotionally overwhelmed patients get when dealing with their illness.
Item ratings range from 1 (very upset/discouraged) or 4 (very positive/optimistic) with higher scores indicating more positive feelings.
Total scores will be represented by a mean score and will also range from 1 to 4.
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21 months
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Number of preventive care/screenings conducted
Time Frame: 21 months
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Number of preventive care/screenings conducted will be collected via electronic health records.
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21 months
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Number of outpatient visits
Time Frame: 21 months
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Number of outpatient visits will be collected via electronic health records.
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21 months
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Diastolic blood pressure level
Time Frame: 21 months
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Diastolic blood pressure will be measured in mmHg (millimeters of mercury) and collected from the participant's electronic medical record.
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21 months
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Systolic blood pressure level
Time Frame: 21 months
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Systolic blood pressure will be measured in mmHg (millimeters of mercury) and collected from the participant's electronic medical record.
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21 months
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hgA1c level
Time Frame: 21 months
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Glycated haemoglobin (hgA1c) levels will be measured in mmol/mol units and collected from the participant's electronic medical record.
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21 months
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Triglyceride level
Time Frame: 21 months
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Triglyceride levels will be measured in milligrams per deciliter (mg/dL) and collected from the participant's electronic medical record.
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21 months
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High-density lipoprotein (HDL) level
Time Frame: 21 months
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HDL levels will be measured in milligrams per deciliter (mg/dL) and obtained from the participant's electronic medical record.
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21 months
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Low-density lipoprotein (LDL) levels
Time Frame: 21 months
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LDL levels will be measured in milligrams per deciliter (mg/dL) and obtained from the participant's electronic medical record.
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21 months
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Body mass index (BMI) level
Time Frame: 21 months
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BMI levels will be measured in kilograms per square meter (kg/m2) and collected from the participant's electronic medical record.
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21 months
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Self-reported psychiatric symptoms
Time Frame: 21 months
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Psychiatric symptoms will be assessed through multiple subscales of the Symptom Checklist-90-Revised. We will collect subscales related to the symptoms we expect will be affected by Harambee: Anxiety, Depression, Psychoticism, Paranoia, Somatization, Hostility, Interpersonal sensitivity, and Obsessive-compulsiveness.
Internal consistency of the subscales is high (range .77-.90).
Item scores range from 1 (not at all) to 5 (extremely).
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21 months
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Self-reported substance use
Time Frame: 21 months
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Substance use will be assessed using the Addiction Severity Index.
The ASI is a structured interview for evaluating the degree of potential treatment barriers across domains typically affected by alcohol and drug use disorders, including psychiatric and social considerations.
For the purposes of this investigation, we will limit administration to the alcohol and drug use subscales.
The alcohol and drug subscales concern the frequency and severity of use in the past 30 days.
The ASI has been rigorously assessed within similar client populations and shown to demonstrate high reliability for assessing alcohol and drug use and its consequences, Cronbach alpha = 0.65-0.89.
Item ratings range from 0 (not at all) to 4 (extremely).
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21 months
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Self-reported quality of functioning
Time Frame: 21 months
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Functional status will be assessed by the Quality of Well-being scale (QWB-SA), a common health related quality of life measuring health utilities.
Most scores are coded 0 (no) or 1 (yes).
Overall, the QWB-SA includes five parts assessing physical and mental health symptoms (chronic and acute), self-care, mobility, physical functioning, and social activities.
In all, the domain scores are combined into a single index score ranging from 0.09 (lowest possible health state) to 1 for perfect health.
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21 months
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Self-reported overall wellness
Time Frame: 21 months
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Overall Wellness will be measured by the 8 Dimensions of Wellness Measure.
This measure assesses the extent to which respondents engage in behaviors that promote physical, intellectual, environmental, spiritual, emotional, financial, social, and occupational wellness.
Item ratings range from 4 (always true) to 1 (never true), with higher scores indicating greater wellness.
Subscale and total scores are represented by mean scores, accounting for missing data, and have the same range of 1 to 4.
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21 months
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Number of Emergency Department visits
Time Frame: 21 months
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Number of Emergency Department visits will be collected via electronic health records.
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21 months
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Number of Hospitalizations
Time Frame: 21 months
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Number of Hospitalizations will be collected via electronic health records.
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21 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chyrell D Bellamy, Ph.D., Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000023089
- R34MH117188-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Research Resources generated will be freely distributed to qualified academic investigators for non-commercial research. Materials generated will be disseminated in accordance with University/Participating institutional and NIH policies. Depending on such policies, materials may be transferred to others under the terms of a material transfer agreement. Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate, to avoid or minimize associated costs.
Research data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. All data obtained from participants will also be shared via the NDCT related to Mental Illness. In enrolling participants, necessary information will be obtained to generate a GUID.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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