Chronic Medical ConditionNCT03673852
Peer Wellness Enhancement For Patients With Serious Mental Illness and High Medical Costs
A study testing WE Harambee and Behavioral Health Home Enrollment in people with Chronic Medical Condition, run by Yale University at 1 site in United States.
Trial summary
This research addresses the important public health crisis that people with serious mental illness (SMI) are dying10-20 years younger than the average population, primarily due to chronic, untreated medical conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Medical Condition
- What is being tested?
- WE Harambee and Behavioral Health Home Enrollment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2018to 30 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be CMHC enrolled patients in the Behavioral Health Homes Program over the age of 18 years old
Who cannot join
- Participants who are not CMHC enrolled patients in the Behavioral Health Homes Program and under the age of 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
CT Mental Health Center
New Haven, Connecticut, 06511
About this study
This research addresses the important public health crisis that people with serious mental illness (SMI) are dying10-20 years younger than the average population, primarily due to chronic, untreated medical conditions. This proposal tests the feasibility, acceptability, engagement of target mechanisms, and preliminary effectiveness of a peer-led and peer-developed intervention to improve the health and wellness of people with SMI by addressing underlying social determinants of health. This research will provide key information about target mechanisms underlying peer interventions and establish the evidence needed to advance to a full scale clinical trial.
Read the detailed description
60 Connecticut Mental Health Center patients enrolled in BHH will be recruited for the study. The research team will begin working closely with BHH data administrators and staff to start the recruitment process. A BHH data manager will create a randomly sorted list of the current BHH roster. This list will be stratified with respect to gender, race, and ethnicity so that the research team can collect a stratified sample for this research that is representative of the population. This stratified list will be given to BHH care coordinators, who will contact patients in each strata of the population and provide a brief, scripted introduction to the study, and attempt to obtain permission to contact. A flyer will be posted at the BHH program, providing information about the study for persons interested to self-refer to the research team. The research team will not have access to names of individuals on this roster, and will only be given names and contact information of individuals who provide permission to contact or who self-refer. The research team will then contact patients, provide preliminary information about the study and assessment procedures, answer any questions, and invite patients to participate. A consent and baseline interview time and date will be scheduled, at which time more detailed explanations about the study will be provided, ability to provide informed consent will be assessed, consent forms reviewed, signatures obtained, and release of information forms for retrieval of administrative data and to allow contact with BHH coordinator, if needed. BHH coordinators will continue working down the randomly sorted list to obtain permissions to contact until 60 BHH patients have enrolled and provided consent into the study. After completion of the consent process, patients will be randomly assigned into one of three waves of WE Harambee implementation and baseline interviews will be conducted. The first wave of implementation will be standard WE Harambee intervention, as implemented in our recent pilot trial (i.e., with no modifications or adaptations to design). While Wave 1 participants are receiving the group intervention (consisting of twice a week group meetings), the research team will be analyzing the administrative data and baseline interviews obtained on all 60 participants. Following completion of the 3 months, group intervention, Wave 1 participants will complete a follow-up quantitative interview and a follow-up qualitative interview to gather additional information about specific aspects of the intervention that have worked well, areas for improvement, and questions related to feasibility and acceptability of the intervention thus far. Wave 1 participants will then be offered 1:1 peer mentorship/coaching with a peer leader of his/her choice. Individual peer mentoring will be offered for the next three months. During this time, the research team and stakeholder advisory group will be analyzing the 3-month follow-up data, graphing mean changes from baseline in the targets of the intervention, and analyzing the qualitative interviews. The stakeholder advisory group members are people that have lived experience with both mental and primary healthcare problems. The stakeholder advisory group member's experience navigating the healthcare system will guide the research, providing special attention to the challenges, barriers and facilitators that stakeholders experienced in their journey of healthcare. The data will be shared with the stakeholder advisory group and, in tandem with the research team, identify initial modifications that can be made to the WE Harambee intervention, that can be instituted in Wave 2 administration. As Wave 1 participants are nearing completion of the 12-week individual peer mentoring phase, research team will contact all 60 participants to schedule Time 2 (T2) interviews. The interviews will occur after Wave 1 participants fully complete the intervention and will mirror the baseline (T1) and post-group interview. Adaptations will be formalized for the Wave 2 implementation, which will begin in month 10 of the study. The research process will proceed in a similar manner, with all Wave 2 participants completing a post-group interview and a qualitative interview. Analyses and interpretation of data collected to date will occur while Wave 2 participants are receiving the 1:1 peer mentoring component of the WE Harambee intervention. Adaptations will again be made, this time greater attention will be paid to measures of fidelity and changes to be reflected in the intervention manual, although any changes in process, assessment, or implementation that improves the fit of the intervention will also be made. All 60 participants will complete a T3 assessment following completion of Wave 2. Final adaptations will be made to intervention and tools and in month 17, the third and final wave of 20 participants will be offered the refined intervention. As before, Wave 3 participants will complete a post-group interview and qualitative interviews following completion of the group component of the intervention. Data will be analyzed and interpreted and final adjustments will be made, in conjunction with the stakeholder advisory board, to the implementation manuals, fidelity tools, assessment protocols, and recruitment strategies, in preparation for a full-scale clinical trial. A final assessment will be completed with all 60 participants following the end of Wave 3 (T4; month 23). Recruitment and timeline will be analyzed for between and within-Wave comparisons in target engagement and outcomes. If the hypothesized targets are engaged (i.e., participants demonstrate improvement in the direction expected) and if there is some evidence of the association between target engagement and outcomes, the researchers will move forward with plans to launch full-scale clinical trial. In brief, all 60 patients enrolled in the study will participate in individual interviews in 4 different time periods of the study: T1 (before Wave 1), T2 (after Wave 1 and before Wave 2), T3 (after Wave 2 and before Wave 3), and T4 (after Wave 3). Additionally, each participant will have one additional interview following completion of the group component of the WE Harambee intervention. The post-intervention interviews will be administered to all 60 participants who have completed the group intervention. Thirty Participants will also be invited to participate in a qualitative interview (n=20 from Wave 1, n=5 from Wave 2, n=5 from Wave 3) . The wave-specific interviews are designed to provide within-group, preliminary data that can be used to inform any adaptations/modifications to subsequent waves of intervention.
- Conditions
- Chronic Medical Condition
- Being tested
- WE Harambee, Behavioral Health Home Enrollment
- Keywords
- Serious Mental Illness (SMI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WE HarambeeBehavioural
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.
Behavioral Health Home EnrollmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer Wellness Enhancement (WE Harambee) | Other | 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. Receives: Behavioral: WE Harambee |
| Behavioral Health Home enrollment | Other | 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. Receives: Behavioral: Behavioral Health Home Enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported coping and problem solving
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.
Measured: 21 months
Self-reported self-efficacy
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.
Measured: 21 months
Self-reported hope
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.
Measured: 21 months
Self-reported social support
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.
Measured: 21 months
Self-reported sense of community
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.
Measured: 21 months
Self-reported empowerment
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.
Measured: 21 months
Self-reported patient activation
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.
Measured: 21 months
Self-reported health literacy
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.
Measured: 21 months
Self-reported barriers and facilitators to healthcare
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.
Measured: 21 months
Secondary outcomes (17)
Self-reported illness self management
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.
Measured: 21 months
Self-reported engagement in healthcare
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.
Measured: 21 months
Number of preventive care/screenings conducted
Number of preventive care/screenings conducted will be collected via electronic health records.
Measured: 21 months
Number of outpatient visits
Number of outpatient visits will be collected via electronic health records.
Measured: 21 months
Diastolic blood pressure level
Diastolic blood pressure will be measured in mmHg (millimeters of mercury) and collected from the participant's electronic medical record.
Measured: 21 months
Systolic blood pressure level
Systolic blood pressure will be measured in mmHg (millimeters of mercury) and collected from the participant's electronic medical record.
Measured: 21 months
hgA1c level
Glycated haemoglobin (hgA1c) levels will be measured in mmol/mol units and collected from the participant's electronic medical record.
Measured: 21 months
Triglyceride level
Triglyceride levels will be measured in milligrams per deciliter (mg/dL) and collected from the participant's electronic medical record.
Measured: 21 months
High-density lipoprotein (HDL) level
HDL levels will be measured in milligrams per deciliter (mg/dL) and obtained from the participant's electronic medical record.
Measured: 21 months
Low-density lipoprotein (LDL) levels
LDL levels will be measured in milligrams per deciliter (mg/dL) and obtained from the participant's electronic medical record.
Measured: 21 months
Body mass index (BMI) level
BMI levels will be measured in kilograms per square meter (kg/m2) and collected from the participant's electronic medical record.
Measured: 21 months
Self-reported psychiatric symptoms
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).
Measured: 21 months
Self-reported substance use
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).
Measured: 21 months
Self-reported quality of functioning
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.
Measured: 21 months
Self-reported overall wellness
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.
Measured: 21 months
Number of Emergency Department visits
Number of Emergency Department visits will be collected via electronic health records.
Measured: 21 months
Number of Hospitalizations
Number of Hospitalizations will be collected via electronic health records.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start6 Dec 2018
- Primary completion30 May 2021
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Medical ConditionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Chyrell D Bellamy, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673852
- Sponsor's protocol ID
- 2000023089
- Other IDs
- R34MH117188-01
- Status last verified
- Feb 2022
- First submitted
- 9 Aug 2018
- Last updated
- 17 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Wellness Enhancement For Patients With Serious Mental Illness and High Medical Costs
- ClinicalTrials.gov ID
- NCT03673852
- Acronym / sponsor ID
- 2000023089
- Conditions
- Chronic Medical Condition
- Keywords
- Serious Mental Illness (SMI)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 17 Sep 2018 (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.
This research addresses the important public health crisis that people with serious mental illness (SMI) are dying10-20 years younger than the average population, primarily due to chronic, untreated medical conditions. This proposal tests the feasibility, acceptability, engagement of target mechanisms, and preliminary effectiveness of a peer-led and peer-developed intervention to improve the health and wellness of people with SMI by addressing underlying social determinants of health. This research will provide key information about target mechanisms underlying peer interventions and establish the evidence needed to advance to a full scale clinical trial.
Detailed description
60 Connecticut Mental Health Center patients enrolled in BHH will be recruited for the study. The research team will begin working closely with BHH data administrators and staff to start the recruitment process. A BHH data manager will create a randomly sorted list of the current BHH roster. This list will be stratified with respect to gender, race, and ethnicity so that the research team can collect a stratified sample for this research that is representative of the population. This stratified list will be given to BHH care coordinators, who will contact patients in each strata of the population and provide a brief, scripted introduction to the study, and attempt to obtain permission to contact. A flyer will be posted at the BHH program, providing information about the study for persons interested to self-refer to the research team. The research team will not have access to names of individuals on this roster, and will only be given names and contact information of individuals who provide permission to contact or who self-refer. The research team will then contact patients, provide preliminary information about the study and assessment procedures, answer any questions, and invite patients to participate. A consent and baseline interview time and date will be scheduled, at which time more detailed explanations about the study will be provided, ability to provide informed consent will be assessed, consent forms reviewed, signatures obtained, and release of information forms for retrieval of administrative data and to allow contact with BHH coordinator, if needed. BHH coordinators will continue working down the randomly sorted list to obtain permissions to contact until 60 BHH patients have enrolled and provided consent into the study. After completion of the consent process, patients will be randomly assigned into one of three waves of WE Harambee implementation and baseline interviews will be conducted. The first wave of implementation will be standard WE Harambee intervention, as implemented in our recent pilot trial (i.e., with no modifications or adaptations to design). While Wave 1 participants are receiving the group intervention (consisting of twice a week group meetings), the research team will be analyzing the administrative data and baseline interviews obtained on all 60 participants. Following completion of the 3 months, group intervention, Wave 1 participants will complete a follow-up quantitative interview and a follow-up qualitative interview to gather additional information about specific aspects of the intervention that have worked well, areas for improvement, and questions related to feasibility and acceptability of the intervention thus far. Wave 1 participants will then be offered 1:1 peer mentorship/coaching with a peer leader of his/her choice. Individual peer mentoring will be offered for the next three months. During this time, the research team and stakeholder advisory group will be analyzing the 3-month follow-up data, graphing mean changes from baseline in the targets of the intervention, and analyzing the qualitative interviews. The stakeholder advisory group members are people that have lived experience with both mental and primary healthcare problems. The stakeholder advisory group member's experience navigating the healthcare system will guide the research, providing special attention to the challenges, barriers and facilitators that stakeholders experienced in their journey of healthcare. The data will be shared with the stakeholder advisory group and, in tandem with the research team, identify initial modifications that can be made to the WE Harambee intervention, that can be instituted in Wave 2 administration. As Wave 1 participants are nearing completion of the 12-week individual peer mentoring phase, research team will contact all 60 participants to schedule Time 2 (T2) interviews. The interviews will occur after Wave 1 participants fully complete the intervention and will mirror the baseline (T1) and post-group interview. Adaptations will be formalized for the Wave 2 implementation, which will begin in month 10 of the study. The research process will proceed in a similar manner, with all Wave 2 participants completing a post-group interview and a qualitative interview. Analyses and interpretation of data collected to date will occur while Wave 2 participants are receiving the 1:1 peer mentoring component of the WE Harambee intervention. Adaptations will again be made, this time greater attention will be paid to measures of fidelity and changes to be reflected in the intervention manual, although any changes in process, assessment, or implementation that improves the fit of the intervention will also be made. All 60 participants will complete a T3 assessment following completion of Wave 2. Final adaptations will be made to intervention and tools and in month 17, the third and final wave of 20 participants will be offered the refined intervention. As before, Wave 3 participants will complete a post-group interview and qualitative interviews following completion of the group component of the intervention. Data will be analyzed and interpreted and final adjustments will be made, in conjunction with the stakeholder advisory board, to the implementation manuals, fidelity tools, assessment protocols, and recruitment strategies, in preparation for a full-scale clinical trial. A final assessment will be completed with all 60 participants following the end of Wave 3 (T4; month 23). Recruitment and timeline will be analyzed for between and within-Wave comparisons in target engagement and outcomes. If the hypothesized targets are engaged (i.e., participants demonstrate improvement in the direction expected) and if there is some evidence of the association between target engagement and outcomes, the researchers will move forward with plans to launch full-scale clinical trial. In brief, all 60 patients enrolled in the study will participate in individual interviews in 4 different time periods of the study: T1 (before Wave 1), T2 (after Wave 1 and before Wave 2), T3 (after Wave 2 and before Wave 3), and T4 (after Wave 3). Additionally, each participant will have one additional interview following completion of the group component of the WE Harambee intervention. The post-intervention interviews will be administered to all 60 participants who have completed the group intervention. Thirty Participants will also be invited to participate in a qualitative interview (n=20 from Wave 1, n=5 from Wave 2, n=5 from Wave 3) . The wave-specific interviews are designed to provide within-group, preliminary data that can be used to inform any adaptations/modifications to subsequent waves of intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Wellness Enhancement (WE Harambee) | Other | Behavioral: WE HarambeeThis 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. |
| Behavioral Health Home enrollment | Other | Behavioral: Behavioral Health Home EnrollmentIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be CMHC enrolled patients in the Behavioral Health Homes Program over the age of 18 years old
Key exclusion criteria (1 listed)
- Participants who are not CMHC enrolled patients in the Behavioral Health Homes Program and under the age of 18 years old
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 |
|---|---|---|
| WE HarambeeWE 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. | Behavioural | Peer Wellness Enhancement (WE Harambee) |
| Behavioral Health Home EnrollmentA 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. | Behavioural | Behavioral Health Home enrollment |
Primary outcome
Self-reported coping and problem solving
Time frame: 21 months
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.
Self-reported self-efficacy
Time frame: 21 months
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.
Self-reported hope
Time frame: 21 months
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.
Self-reported social support
Time frame: 21 months
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.
Self-reported sense of community
Time frame: 21 months
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.
Self-reported empowerment
Time frame: 21 months
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.
Self-reported patient activation
Time frame: 21 months
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.
Self-reported health literacy
Time frame: 21 months
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.
Self-reported barriers and facilitators to healthcare
Time frame: 21 months
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.
17 secondary outcomes
Self-reported illness self management
Time frame: 21 months
Self-reported engagement in healthcare
Time frame: 21 months
Number of preventive care/screenings conducted
Time frame: 21 months
Number of outpatient visits
Time frame: 21 months
Diastolic blood pressure level
Time frame: 21 months
Systolic blood pressure level
Time frame: 21 months
hgA1c level
Time frame: 21 months
Triglyceride level
Time frame: 21 months
High-density lipoprotein (HDL) level
Time frame: 21 months
Low-density lipoprotein (LDL) levels
Time frame: 21 months
Body mass index (BMI) level
Time frame: 21 months
Self-reported psychiatric symptoms
Time frame: 21 months
Self-reported substance use
Time frame: 21 months
Self-reported quality of functioning
Time frame: 21 months
Self-reported overall wellness
Time frame: 21 months
Number of Emergency Department visits
Time frame: 21 months
Number of Hospitalizations
Time frame: 21 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: Yes. 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.
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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.
Chyrell D Bellamy, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WE Harambee and Behavioral Health Home Enrollment in people with Chronic Medical Condition, run by Yale University at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Self-reported coping and problem solving (time frame: 21 months). The study lists 9 primary outcomes in all. 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 17 Feb 2022.