Mental DisorderDRRRP-PHNNCT05018351
Peer Navigators for the Health and Wellness of People With Psychiatric Disabilities
A study testing Integrated Care and Peer Navigation in people with Mental Disorder and Physical Illness, run by Illinois Institute of Technology at 2 sites in United States.
Trial summary
Adults with psychiatric disabilities get sick and die 20 to 30 years younger than same-age peers, with even greater disparities occurring when the person is from a low SES or of color. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorder, Physical Illness
- What is being tested?
- Integrated Care and Peer Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 May 2021to 1 Sep 2025
- 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
- Age 18 or older
- Serious mental illness (as indicated by disability)
- A desire to improve their physical health/wellness and prevent disease through peer health navigation
- Willing to attend
- Active Thresholds member residing in the catchment area (Chicago South Side)
Who cannot join
- Currently receiving services from a peer support specialist to work on health-related goals
- Currently receiving Assertive Community Treatment services
- Not an active Thresholds member
- Does not reside in the catchment area (Chicago South Side)
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Thresholds
Chicago, Illinois, 60613
Lisa Razzano, PhD, 773-432-6228, Lisa.Razzano@thresholds.org
- Recruiting
Illinois Institute of Technology
Chicago, Illinois, 60616
Patrick W Corrigan, PsyD, 312-567-6751, corrigan@iit.edu
Carla D Kundert, MS, 312-567-6982
About this study
Adults with psychiatric disabilities get sick and die 20 to 30 years younger than same-age peers, with even greater disparities occurring when the person is from a low SES or of color. Factors explaining this difference are complex and include genetic comorbidity, iatrogenic effects of medication, life choices, and life consequences. These factors are worsened by service disparities which are often fragmented in the public health system.
Peer navigators are part of a program in which providers escort people with psychiatric disabilities around the fragmented system to meet their health and wellness goals, often a demanding task for the person who has needs addressed at clinics, labs, and pharmacies spread across an urban area. Navigators are peers because they have lived experience of recovery and are often from similar ethnic groups. A community-based participatory research program supported by NIMHD and PCORI developed a peer navigator program specific to the needs of people with psychiatric disabilities. Results of two small pilots funded by NIMHD and PCORI showed the Peer Navigator Program (PNP) led to significant improved service engagement which corresponded with better health, recovery, and quality of life. The studies included fidelity measurement which showed peer navigators conducting the intervention at high levels of fidelity.
The current research is an efficacy study with a more fully powered test of PNP versus treatment as usual, which is integrated care (TAU-IC). The investigators aim to recruit 300 adults with psychiatric disability who wish to improve physical health/wellness through peer health navigation randomized to TAU-IC or TAU-IC plus PNP. Individuals will participate in assigned interventions as part of 8-month cohorts with data being obtained at baseline, 4, 8, and 12 months. Data will include personal descriptors (demographics, diagnosis, life consequences report), outcomes (service engagement, physical symptoms, blood pressure, recovery, and quality of life), mediators (personal empowerment, self-determination, and perceived relationship for recovery), and process measures (fidelity, feasibility, and acceptability). Investigators hypothesize that those in PNP intervention will have improved outcomes over the integrated care as usual. A cost-benefit analysis will seek to model impact based on quality-adjusted life years. Larger effect sizes will permit post hoc identification of how PNP effects vary by participant characteristics such as ethnicity and gender.
Read the detailed description
Morbidity and mortality rates among people with psychiatric disabilities due to physical illness are very high such that people in this group die ten to thirty years younger than same age peers. This disparity is even worse among people with psychiatric disabilities from low SES groups. Factors explaining this difference are complex and include genetic comorbidity, iatrogenic effects of medication, life choices (e.g., modifiable health risks); and life consequences (e.g., harm related to poverty, homelessness, and poor diet).
Except for genetic comorbidities, these factors are worsened by service disparities which are often fragmented in the public health system. Community health work and personal navigation are methods that have shown benefits in fragmented systems. Peer navigators (PN) are an especially promising approach to helping people avail existing services. Peers are people with lived experience of recovery, often from similar ethnic groups. Peer navigators target service engagement that improves illness management and health. They do this with practical in-the-field services where they, among other things, accompany the person with health needs to their various appointments. This, in turn, seems to enhance personal report of recovery and quality of life as well as objective indicators such as hospitalization use, medication self-administration, and blood pressure. Peer navigator effects on targeted service engagement are mediated by personal empowerment and self-determination which is influenced by perceptions of the provider relationship promoting recovery. Two pilot studies have supported the feasibility and preliminary effect sizes of peer navigation. The current efficacy study will more completely examine feasibility and impact. In addition, data from this project will inform scaling up the intervention to other sites as well as assess training needs for wide-scale utilization.
People with psychiatric disabilities who wish to improve their physical health/wellness and prevent disease through peer health navigation will be recruited from Thresholds members and subsequently randomized to one of two conditions provided for eight months:
- Treatment as usually in integrated care (TAU-IC) or
- Peer navigator program (PNP) provided by providers who are peers (e.g., in recovery from psychiatric disabilities) plus TAU-IC
Investigators seek 150 participants per condition (N=300) to reach statistical power goals. Investigators will recruit 354 participants to account for expected loss-to-follow-up. The PNP intervention will last 8 months, with a 4-month maintenance phase. The PNP intervention includes in-vivo support with healthcare provider appointments, health-related goal-setting, and wellness activities.
This project is led by a community-based participatory research (CBPR) team comprised of people with lived experience partnering with the science team. The CBPR team will also be involved in dissemination and utilization activities. The PNP will be conducted by Thresholds, the largest provider of psychiatric rehabilitation in the Midwest. Scientists from the Chicago Health Disparities Center at Illinois Institute of Technology will implement research design and analyses.
Investigators will analyze fidelity, process, outcome and impact data, including the effect of PNP on blood pressure (when COVID-19 precautions allow for in-person data collection), made/accomplished healthcare contacts, perceived physical and mental health, medication adherence, depression, anxiety, satisfaction with health services, recovery, insurance status, hospital/ER use, medication compliance, and quality of life. Measures will be repeated at 4, 8, and 12 months. To understand the impact of peerness, self-determination, and personal empowerment as possible mediators, investigators will assess perceptions of peer disclosure, recovery promoting relationships, empowerment and perceived competence in managing health. Investigators' main hypothesis is that the PNP condition will lead to enhanced healthcare contacts, improved health, and increased engagement in health behaviors compared with the TAU-IC condition. Findings will advance knowledge and services to reduce disparities in comorbid health conditions for people with psychiatric disabilities.
- Conditions
- Mental Disorder, Physical Illness
- Being tested
- Integrated Care, Peer Navigation
- Keywords
- Mental Disorder, Physical Illness, Psychiatric Disability, Peer Navigator, Serious Mental Illness, Physical Health
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated CareBehavioural
Participants receive integrated physical and mental health care from their usual provider.
Peer NavigationBehavioural
Peer navigators will meet individually and face-to-face with participants to address their health and weight goals (i.e. working on health-related goals, attending health care appointments. and facilitating follow-up activities related to healthcare appointments).
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual-Integrated Care (TAU-IC) | Active comparator | Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-half of research participants will be randomized to integrated care alone. Receives: Behavioral: Integrated Care |
| Peer Navigator Program (PNP) | Experimental | Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* scheduling and attending healthcare appointments;
* partnering with participant on tasks that arise from appointments;
* health-related goal setting; and
* taking action-steps toward health-related goals. Receives: Behavioral: Peer Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Scores at Months 4, 8, and 12
Assesses change in participants' health status and health-related quality of life over the 12 months of the study along 9 domains (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health). Each of the aforementioned scales have a range of scores from 0 (minimum) - 100 (maximum), with higher scores indicating better outcomes (e.g., a score of 100 on the physical functioning scale indicates no problems with physical functioning). The investigators will evaluate change along all 9 domains. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Measured: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Texas Christian University Health Form (TCU-HLTHFORM) Scores at Months 4, 8, and 12
This 24-item measure will assess respondents' experience with physical health problems (e.g., stomach problems or ulcers, bladder infections) and mental health problems (e.g., tired for no good reason, nervous) over the 12 months of the study. The TCU-HLTHFORM assesses health along two domains: psychological distress and physical health. The psychological distress scale scores range from 10 (minimum) to 5 (maximum), with scores of 25-29 indicating high levels of distress, and scores of 30-50 indicating very high levels of distress, thus worse outcomes. The physical health items range from 11 (minimum) to 55 (maximum). Higher scores on these items indicate higher levels of physical health problems, thus worse outcomes. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Measured: Baseline, 4 months, 8 months, 12 months
Secondary outcomes (10)
Change from Baseline in Quality of Life Scale (QLS) Scores at Months 4, 8, and 12
Assesses life domains including general life, daily activities, and social contact. Participants respond on a 7-point scale from "delighted" to "terrible". Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Measured: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Recovery Assessment Scale-Revised (RAS-R) Scores at Months 4, 8, and 12
Measure of recovery with 24 items across five factors, with higher scores on each indicating better outcomes. Personal confidence and hope scale scores range from 9 (min) to 45 (max), with higher scores indicating more personal confidence and hope, i.e., better outcomes. Willingness to ask for help scale scores range from 3 (min) to 15 (max), with higher scores indicating greater willingness to ask for help, i.e., better outcomes. Goal and success orientation scale scores range from 5 (min) to 25 (max), with higher scores indicating higher levels of goal and success orientation, i.e., better outcomes. Reliance on others scale scores range from 4 (min) to 20 (max), with higher scores indicating greater reliance on others, i.e., better outcomes. Not dominated by symptoms scale scores range from 3 (min) to 15 (max), with higher scores indicating less domination by symptoms, i.e., better outcomes. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Measured: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Systolic and Diastolic Blood Pressure at Months 4, 8, and 12
Change in systolic and diastolic blood pressure--to be collected when COVID-19 guidelines allow in-person interviews to be conducted. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Measured: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Center for Epidemiologic Studies Depression Scale-Depression 10-item version (CES-D 10) Scores at Months 4, 8, and 12
Assess change in participants' experienced symptoms associated with depression. Scores range from 0-30, with higher scores indicating presence of depression, i.e., worse outcomes. A total score greater than 10 is considered depressed. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Measured: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Scores at Months 4, 8, and 12
Measures severity of anxiety. Scores range from 0-7, with higher scores indicating more severe anxiety, i.e., worse outcomes. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Measured: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Health Literacy Questionnaire (HLQ) Scores at Months 4, 8, and 12
Three scales of the HLQ to measure (1) active health management, (2) actively engaging with health providers, (3) navigating the healthcare system. Active health management scale scores range from 5 (min) to 25 (max), with higher scores indicating more recognition of the importance of and responsibility for one's own health, i.e., better outcomes. Actively engaging with health providers scale scores range from 5 (min) to 25 (max), with higher scores indicating more proactivity about one's health, more control in relationships with health providers, greater empowerment, i.e., better outcomes. Navigating the healthcare system scale scores range from 6 (min) to 30 (max), with higher scores indicating greater ability to find out about \& advocate for oneself in service and support settings, i.e., better outcomes.
Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Measured: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Medication Questionnaire (MQ) Scores at Months 4, 8, and 12
Self-report measure of adherence to prescribed medication regimens for both physical and mental health. Participants report on a scale of 1-100 their level of adherence to prescription medication regimens, with higher scores indicating greater adherence, i.e., better outcomes. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Measured: Baseline, 4 months, 8 months, 12 months
Change from Baseline in COVID-19 Social Distancing and Hygiene Scale Scores at Months 4, 8, and 12
12 items to assess adherence to public health recommendations to reduce transmission likelihood of COVID-19. Adapted from the Multi-Ethnic Study of Atherosclerosis (MESA) COVID-19 Questionnaire. Scores range from 12 (min) - 60 (max), with higher scores indicating greater adherence to COVID-19 health and safety guidelines, i.e., better outcomes. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Measured: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Smoking Questionnaire Scores at Months 4, 8, and 12
Items assessing smoking status and desire to quit. Pariticpants are asked if they are a current smoker and, if so, how many cigarettes do they smoke per day. If participant indicates they are a current smoker, a single item assesses motivation to quit, with 1 being not motivated at all and 7 being very motivated. Higher scores indicate better outcomes. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Measured: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Personal Satisfaction Interview Scores at Months 4, 8, and 12
An 18-item measure of satisfaction with healthcare, with higher scores indicating better outcomes, comprises these scales: General satisfaction (2-10), with higher scores indicating greater general satisfaction; Technical quality (4-20), with higher scores indicating greater satisfaction with the quality of care; Interpersonal manner (2-10), with higher scores indicating greater satisfaction with the interpersonal demeanor of healthcare providers; Communication (2-10), with higher scores indicating more satisfaction with providers' communication; Financial aspects (2-10), with higher scores indicating more satisfaction with cost of care; Time spent with doctor (2-10), with higher scores indicating more satisfaction with the amount of time spent with their doctor; Accessibility \& convenience (4-20), with higher scores indicating greater satisfaction with access and convenience. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Measured: Baseline, 4 months, 8 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start17 May 2021
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Persons are randomly assigned to receive either: A) treatment as usual (TAU-IC), which is Integrated Care services with Thresholds, OR B) peer navigator program (PNP), which includes in-vivo support with managing physical health and wellness at least weekly
- Masking
- None (open label)
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Illinois Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, Thresholds Inc.
- Responsible party
- Sponsor
- Investigators
- Patrick W Corrigan, PsyD, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018351
- Sponsor's protocol ID
- 90DPHF0008
- Acronym
- DRRRP-PHN
- Status last verified
- Mar 2022
- First submitted
- 1 Jun 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be available to researchers and service agencies, with quantitative data available from an expected 300 participants with psychiatric disabilities who report a desire to improve physical health/wellness and prevent disease through peer navigation. No identifying information will be connected to the data and investigators do not believe that there is a possibility of deductive disclosure of subjects with unusual characteristics. Regardless, to ensure the protection of the human subjects involved in this research, investigators will make the data and associated documentation available to users only under a data-sharing agreement. Notice of available data will be posted in appropriate arenas including websites for the project: www.chicagohealthdisparities.org and www.ncse1.org.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Navigators for the Health and Wellness of People With Psychiatric Disabilities
- ClinicalTrials.gov ID
- NCT05018351
- Acronym / sponsor ID
- DRRRP-PHN / 90DPHF0008
- Conditions
- Mental Disorder, Physical Illness
- Keywords
- Mental Disorder, Physical Illness, Psychiatric Disability, Peer Navigator, Serious Mental Illness, Physical Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Illinois Institute of TechnologyUniversity, hospital or other
- Collaborators
- Arizona State University, Thresholds Inc.
- Study start
- 17 May 2021 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 24 Aug 2021 (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.
Adults with psychiatric disabilities get sick and die 20 to 30 years younger than same-age peers, with even greater disparities occurring when the person is from a low SES or of color. Factors explaining this difference are complex and include genetic comorbidity, iatrogenic effects of medication, life choices, and life consequences. These factors are worsened by service disparities which are often fragmented in the public health system.
Peer navigators are part of a program in which providers escort people with psychiatric disabilities around the fragmented system to meet their health and wellness goals, often a demanding task for the person who has needs addressed at clinics, labs, and pharmacies spread across an urban area. Navigators are peers because they have lived experience of recovery and are often from similar ethnic groups. A community-based participatory research program supported by NIMHD and PCORI developed a peer navigator program specific to the needs of people with psychiatric disabilities. Results of two small pilots funded by NIMHD and PCORI showed the Peer Navigator Program (PNP) led to significant improved service engagement which corresponded with better health, recovery, and quality of life. The studies included fidelity measurement which showed peer navigators conducting the intervention at high levels of fidelity.
The current research is an efficacy study with a more fully powered test of PNP versus treatment as usual, which is integrated care (TAU-IC). The investigators aim to recruit 300 adults with psychiatric disability who wish to improve physical health/wellness through peer health navigation randomized to TAU-IC or TAU-IC plus PNP. Individuals will participate in assigned interventions as part of 8-month cohorts with data being obtained at baseline, 4, 8, and 12 months. Data will include personal descriptors (demographics, diagnosis, life consequences report), outcomes (service engagement, physical symptoms, blood pressure, recovery, and quality of life), mediators (personal empowerment, self-determination, and perceived relationship for recovery), and process measures (fidelity, feasibility, and acceptability). Investigators hypothesize that those in PNP intervention will have improved outcomes over the integrated care as usual. A cost-benefit analysis will seek to model impact based on quality-adjusted life years. Larger effect sizes will permit post hoc identification of how PNP effects vary by participant characteristics such as ethnicity and gender.
Detailed description
Morbidity and mortality rates among people with psychiatric disabilities due to physical illness are very high such that people in this group die ten to thirty years younger than same age peers. This disparity is even worse among people with psychiatric disabilities from low SES groups. Factors explaining this difference are complex and include genetic comorbidity, iatrogenic effects of medication, life choices (e.g., modifiable health risks); and life consequences (e.g., harm related to poverty, homelessness, and poor diet).
Except for genetic comorbidities, these factors are worsened by service disparities which are often fragmented in the public health system. Community health work and personal navigation are methods that have shown benefits in fragmented systems. Peer navigators (PN) are an especially promising approach to helping people avail existing services. Peers are people with lived experience of recovery, often from similar ethnic groups. Peer navigators target service engagement that improves illness management and health. They do this with practical in-the-field services where they, among other things, accompany the person with health needs to their various appointments. This, in turn, seems to enhance personal report of recovery and quality of life as well as objective indicators such as hospitalization use, medication self-administration, and blood pressure. Peer navigator effects on targeted service engagement are mediated by personal empowerment and self-determination which is influenced by perceptions of the provider relationship promoting recovery. Two pilot studies have supported the feasibility and preliminary effect sizes of peer navigation. The current efficacy study will more completely examine feasibility and impact. In addition, data from this project will inform scaling up the intervention to other sites as well as assess training needs for wide-scale utilization.
People with psychiatric disabilities who wish to improve their physical health/wellness and prevent disease through peer health navigation will be recruited from Thresholds members and subsequently randomized to one of two conditions provided for eight months:
- Treatment as usually in integrated care (TAU-IC) or
- Peer navigator program (PNP) provided by providers who are peers (e.g., in recovery from psychiatric disabilities) plus TAU-IC
Investigators seek 150 participants per condition (N=300) to reach statistical power goals. Investigators will recruit 354 participants to account for expected loss-to-follow-up. The PNP intervention will last 8 months, with a 4-month maintenance phase. The PNP intervention includes in-vivo support with healthcare provider appointments, health-related goal-setting, and wellness activities.
This project is led by a community-based participatory research (CBPR) team comprised of people with lived experience partnering with the science team. The CBPR team will also be involved in dissemination and utilization activities. The PNP will be conducted by Thresholds, the largest provider of psychiatric rehabilitation in the Midwest. Scientists from the Chicago Health Disparities Center at Illinois Institute of Technology will implement research design and analyses.
Investigators will analyze fidelity, process, outcome and impact data, including the effect of PNP on blood pressure (when COVID-19 precautions allow for in-person data collection), made/accomplished healthcare contacts, perceived physical and mental health, medication adherence, depression, anxiety, satisfaction with health services, recovery, insurance status, hospital/ER use, medication compliance, and quality of life. Measures will be repeated at 4, 8, and 12 months. To understand the impact of peerness, self-determination, and personal empowerment as possible mediators, investigators will assess perceptions of peer disclosure, recovery promoting relationships, empowerment and perceived competence in managing health. Investigators' main hypothesis is that the PNP condition will lead to enhanced healthcare contacts, improved health, and increased engagement in health behaviors compared with the TAU-IC condition. Findings will advance knowledge and services to reduce disparities in comorbid health conditions for people with psychiatric disabilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Persons are randomly assigned to receive either: A) treatment as usual (TAU-IC), which is Integrated Care services with Thresholds, OR B) peer navigator program (PNP), which includes in-vivo support with managing physical health and wellness at least weekly
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual-Integrated Care (TAU-IC) | Active comparator | Behavioral: Integrated CareParticipants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-half of research participants will be randomized to integrated care alone. |
| Peer Navigator Program (PNP) | Experimental | Behavioral: Peer NavigationPeer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include: * scheduling and attending healthcare appointments; * partnering with participant on tasks that arise from appointments; * health-related goal setting; and * taking action-steps toward health-related goals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Serious mental illness (as indicated by disability)
- A desire to improve their physical health/wellness and prevent disease through peer health navigation
- Willing to attend
- Active Thresholds member residing in the catchment area (Chicago South Side)
Key exclusion criteria (4 listed)
- Currently receiving services from a peer support specialist to work on health-related goals
- Currently receiving Assertive Community Treatment services
- Not an active Thresholds member
- Does not reside in the catchment area (Chicago South Side)
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 |
|---|---|---|
| Integrated CareParticipants receive integrated physical and mental health care from their usual provider. | Behavioural | Treatment as Usual-Integrated Care (TAU-IC) |
| Peer NavigationPeer navigators will meet individually and face-to-face with participants to address their health and weight goals (i.e. working on health-related goals, attending health care appointments. and facilitating follow-up activities related to healthcare appointments). | Behavioural | Peer Navigator Program (PNP) |
Primary outcome
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Scores at Months 4, 8, and 12
Time frame: Baseline, 4 months, 8 months, 12 months
Assesses change in participants' health status and health-related quality of life over the 12 months of the study along 9 domains (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health). Each of the aforementioned scales have a range of scores from 0 (minimum) - 100 (maximum), with higher scores indicating better outcomes (e.g., a score of 100 on the physical functioning scale indicates no problems with physical functioning). The investigators will evaluate change along all 9 domains. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Change from Baseline in Texas Christian University Health Form (TCU-HLTHFORM) Scores at Months 4, 8, and 12
Time frame: Baseline, 4 months, 8 months, 12 months
This 24-item measure will assess respondents' experience with physical health problems (e.g., stomach problems or ulcers, bladder infections) and mental health problems (e.g., tired for no good reason, nervous) over the 12 months of the study. The TCU-HLTHFORM assesses health along two domains: psychological distress and physical health. The psychological distress scale scores range from 10 (minimum) to 5 (maximum), with scores of 25-29 indicating high levels of distress, and scores of 30-50 indicating very high levels of distress, thus worse outcomes. The physical health items range from 11 (minimum) to 55 (maximum). Higher scores on these items indicate higher levels of physical health problems, thus worse outcomes. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
10 secondary outcomes
Change from Baseline in Quality of Life Scale (QLS) Scores at Months 4, 8, and 12
Time frame: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Recovery Assessment Scale-Revised (RAS-R) Scores at Months 4, 8, and 12
Time frame: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Systolic and Diastolic Blood Pressure at Months 4, 8, and 12
Time frame: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Center for Epidemiologic Studies Depression Scale-Depression 10-item version (CES-D 10) Scores at Months 4, 8, and 12
Time frame: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Scores at Months 4, 8, and 12
Time frame: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Health Literacy Questionnaire (HLQ) Scores at Months 4, 8, and 12
Time frame: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Medication Questionnaire (MQ) Scores at Months 4, 8, and 12
Time frame: Baseline, 4 months, 8 months, 12 months
Change from Baseline in COVID-19 Social Distancing and Hygiene Scale Scores at Months 4, 8, and 12
Time frame: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Smoking Questionnaire Scores at Months 4, 8, and 12
Time frame: Baseline, 4 months, 8 months, 12 months
Change from Baseline in Personal Satisfaction Interview Scores at Months 4, 8, and 12
Time frame: Baseline, 4 months, 8 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: Yes. Results will be available to researchers and service agencies, with quantitative data available from an expected 300 participants with psychiatric disabilities who report a desire to improve physical health/wellness and prevent disease through peer navigation. No identifying information will be connected to the data and investigators do not believe that there is a possibility of deductive disclosure of subjects with unusual characteristics. Regardless, to ensure the protection of the human subjects involved in this research, investigators will make the data and associated documentation available to users only under a data-sharing agreement. Notice of available data will be posted in appropriate arenas including websites for the project: www.chicagohealthdisparities.org and www.ncse1.org.
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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.
Patrick W Corrigan, PsyD principal investigator
Illinois Institute of Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Care and Peer Navigation in people with Mental Disorder and Physical Illness, run by Illinois Institute of Technology at 2 sites 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 5 inclusion and 4 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 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Patrick W Corrigan, PsyD (312-567-7983, corrigan@iit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Scores at Months 4, 8, and 12 (time frame: Baseline, 4 months, 8 months, 12 months). The study lists 2 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 8 Apr 2022.