Mental DisordersNCT02469714
Integrated Care & Patient Navigators for Latinos With Serious Mental Illness
A study testing Peer Navigator Intervention in people with Mental Disorders, run by Illinois Institute of Technology at 1 site in United States.
Trial summary
The health care needs of people with serious mental illness are exacerbated by ethnic health disparities. Latinos with serious mental illness show significant health problems compared to other ethnic groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Peer Navigator Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Identify ethnicity as Hispanic/Latino
- Identify with experience with a mental illness
Who cannot join
- Must be 18 years or older
- Have case manager they met on a regular basis (every week for the past 4 months) for physical health
Trial locations and contacts
1 site in 1 country.
United States1 site
Illinois Institute of Technology
Chicago, Illinois, 60616
About this study
The health care needs of people with serious mental illness are exacerbated by ethnic health disparities. Latinos with serious mental illness show significant health problems compared to other ethnic groups. Therefore, this project is to develop a meaningful peer-navigator program for Latinos with serious mental illness using community-based participatory research (CBPR). Investigators are currently working with seven Hispanic/Latinos with a mental illness that have formed a Consumer Research Team (CRT) that will guide this project. This project will identify and define the problem by conducting a mixed methods research thru qualitative interviews with various stakeholders defined by the investigator's CRT group. The qualitative findings will then be cross-validated in a quantitative survey by 100 Hispanic/Latinos with mental illness. This information will then be used to design an intervention using an integrated care model for Peer-Navigators. Feasibility, accessibility , acceptability and impact of the peer-navigator program will be then evaluated in a randomized control trial (RCT) with 100 Latinos with serious mental illness who will complete measures of physical health, mental health, service use and engagement at baseline, 4, 8, and 12 months. Investigators expect to show physical health improvement with the greater engagement observed in the peer navigator group. Investigators expect a similar improvement in mental health and quality of life as physical health concerns are diminished.
Read the detailed description
Latinos with serious mental illnesses have an inordinately high rate of physical illness leading to a significantly shortened life. One reason is the difficulty in engaging this disenfranchised group in primary care. Integrated services through community-based outreach and care coordination are an innovative and evidence-based practice that improves physical health. Unfortunately, social determinants of health for Latinos are often a barrier to participation in integrated care. Peer navigators offer a strategy that might help members of this group. Peer navigators, in this study, are Latinos with past history of serious mental illness specially trained to help patients meet their health needs. The program will be developed through community-based participatory research (CBPR) representing a hands-on partnership between investigators and a community advisory board made up of patient partners. Given this, investigators aim to do the following. (1) Develop a peer navigator program meant to enhance the impact of already existing integrated services for Latinos with serious mental illness. (2) Using an experimental design, test the impact of peer navigators, compared to existing integrated services alone, on engagement of Latinos with serious mental illness in primary care services. This includes indices of care seeking, appointments, and satisfaction with engagement. Investigators expect these indices to be higher in the group with peer navigators. (3) Determine the comparative impact of peer navigators versus integrated-care-as-usual on subsequent health. Investigators expect to show physical health improvement with the greater engagement observed in the peer navigator group. Investigators expect a similar improvement in mental health and quality of life as physical health concerns are diminished. This proposal represents the partnership between researchers from the Center on Adherence and Self-Determination (a National Institute of Mental Health-funded Center dedicated to understanding service engagement among people with serious mental illness and their health care system) and Trilogy. Consistent with other projects, investigators will develop a Community Advisory Board to conduct CBPR and complete a mixed-methods research project to inform the peer navigator program. Based on a power-analysis, investigators will recruit 100 Latinos with serious mental illness who will complete baseline measures of physical health, mental health, service use and engagement in the previous year, quality of life, and current housing/employment status. Patients will then be randomized to an existing integrated care program for Hispanic/Latinos with mental illness with or without peer navigators for one year. Measures will be repeated at 4, 8, and 12 months.
- Conditions
- Mental Disorders
- Being tested
- Peer Navigator Intervention
- Keywords
- Patient Navigator, Integrated Care, Latino, Mental health and wellness, Physical health and wellness
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Navigator InterventionBehavioural
Also called Peer Navigator
Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group
| Study group | Role | What they receive |
|---|---|---|
| Peer Navigator Intervention | Experimental | Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months. Receives: Behavioral: Peer Navigator Intervention |
| Controlled | No intervention | Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Health Appointment Measure
This scale represents the total achieved appointments and total scheduled appointments. Data was collected weekly and added up per month.The minimum is 0 ( no appointments ) with no maximum (participants were not limited to the number of appointments per week).
Measured: Every week for up to 52 weeks
Secondary outcomes (7)
Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPH)
ATSPPH is a 29 item scale that has been used in more than 150 studies. The scale ranges from 1 (disagreement) to 4 (agreement). Higher overall scores reflect more positive attitudes towards help seeking. Subscales were summed to get the total of each scale. Total scores range from 29-116.
Measured: Baseline (0), 4, 8, and 12 months
Empowerment Scale (EMP)
This widely used scale examines multiple dimensions of perceived personal empowerment in people with serious mental illness. The scale ranges from 1 (strongly agree) to 4 (strongly disagree). The lower the score, the higher level of empowerment. The total scores range from a minimum value of 4 to a maximum value of 16.
Measured: Baseline (0), 4, 8, and 12 months
Recovery Assessment Scale (RAS)
The RAS assesses five factors related to recovery from mental illness including hope and goals. The scale ranges from 1 (strongly disagree) to 5 (strongly agree). A higher score reflects greater attitudes towards recovery. The total score range is 22-110.
Measured: Baseline (0), 4, 8, and 12 months
Medical Outcome Study (SF-36)
This a 36 item short form that is widely adopted measure of medical health outcomes in mental health services research. Each item is scored on a 0 to 100 range. Items in same scale are averaged together to create the 8 scale scores. Higher scores indicate better health. In the current study, the total score it the sum of all scales scores. The total score can range from 0 to 800.
Measured: Baseline (0), 4, 8, and 12 months
Quality of Life Scale (QLS)
The QLS is highly used in services research and comprises 6 items of various domains of independent living. The scale ranges from 1 (terrible) to 7 (delighted). The lower the score the less quality of life. The total scores range 6-42.
Measured: Baseline (0), 4, 8, and 12 months
Availability Health Service Scale (AHSS)
The scale measures the availability of health services. The scale ranges from 1 (Not at all) to 9 (Very much). The lower the score the less availability of a service. Items were summed to get the total of each scale. Score totals range from 26-234.
Measured: Baseline (0), 4, 8, and 12 months
Texas Christian University Health Form- Physical Health Subscale
Assesses physical health in the last 4 months and Emotional/Mental Health in the last 30 days.The scale ranges from 1 (None of the time) to 5 (All of the time). The higher the score, the more health problems. Score totals on the physical health scale range 14-70.
Measured: Baseline (0), 4, 8, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illinois Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Trilogy Inc. Behavioral Healthcare
- Responsible party
- Principal investigator, Patrick Corrigan, Illinois Institute of Technology
- Investigators
- Patrick Corrigan, Psy.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469714
- Sponsor's protocol ID
- PCORI-AD1306-01419
- Status last verified
- Mar 2024
- First submitted
- 5 Jun 2015
- Last updated
- 15 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Corrigan PW. Consumer satisfaction with institutional and community care. Community Ment Health J. 1990 Apr;26(2):151-65. doi: 10.1007/BF00752392.
PubMed 2191833Corrigan PW, Jakus MR. The Patient Satisfaction Interview for partial hospitalization programs. Psychol Rep. 1993 Apr;72(2):387-90. doi: 10.2466/pr0.1993.72.2.387.
PubMed 8488222Fischer EH, Turner JL. Orientations to seeking professional help: development and research utility of an attitude scale. J Consult Clin Psychol. 1970 Aug;35(1):79-90. doi: 10.1037/h0029636. No abstract available.
PubMed 5487612Johansen R, Hestad K, Iversen VC, Agartz I, Sundet K, Andreassen OA, Melle I. Cognitive and clinical factors are associated with service engagement in early-phase schizophrenia spectrum disorders. J Nerv Ment Dis. 2011 Mar;199(3):176-82. doi: 10.1097/NMD.0b013e31820bc2f9.
PubMed 21346488Rogers ES, Chamberlin J, Ellison ML, Crean T. A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatr Serv. 1997 Aug;48(8):1042-7. doi: 10.1176/ps.48.8.1042.
PubMed 9255837Rogers ES, Ralph RO, Salzer MS. Validating the empowerment scale with a multisite sample of consumers of mental health services. Psychiatr Serv. 2010 Sep;61(9):933-6. doi: 10.1176/ps.2010.61.9.933.
PubMed 20810594Corrigan PW, Faber D, Rashid F, Leary M. The construct validity of empowerment among consumers of mental health services. Schizophr Res. 1999 Jul 27;38(1):77-84. doi: 10.1016/s0920-9964(98)00180-7.
PubMed 10427613Corrigan PW, Giffort D, Rashid F, Leary M, Okeke I. Recovery as a psychological construct. Community Ment Health J. 1999 Jun;35(3):231-9. doi: 10.1023/a:1018741302682.
PubMed 10401893Corrigan PW, Salzer M, Ralph RO, Sangster Y, Keck L. Examining the factor structure of the recovery assessment scale. Schizophr Bull. 2004;30(4):1035-41. doi: 10.1093/oxfordjournals.schbul.a007118.
PubMed 15957202Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914de Vet HC, Ader HJ, Terwee CB, Pouwer F. Are factor analytical techniques used appropriately in the validation of health status questionnaires? A systematic review on the quality of factor analysis of the SF-36. Qual Life Res. 2005 Jun;14(5):1203-18; dicussion 1219-21, 1223-4. doi: 10.1007/s11136-004-5742-3.
PubMed 16047498Lehman AF. The well-being of chronic mental patients. Arch Gen Psychiatry. 1983 Apr;40(4):369-73. doi: 10.1001/archpsyc.1983.01790040023003.
PubMed 6838316Lehman AF. The effects of psychiatric symptoms on quality of life assessments among the chronic mentally ill. Eval Program Plann. 1983;6(2):143-51. doi: 10.1016/0149-7189(83)90028-9.
PubMed 10265063Corrigan PW, Buican B, McCraken S. The needs and resources assessment interview for severely mentally ill adults. Psychiatr Serv. 1995 May;46(5):504-5. doi: 10.1176/ps.46.5.504.
PubMed 7627679Contopoulos-Ioannidis DG, Karvouni A, Kouri I, Ioannidis JP. Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review. BMJ. 2009 Jan 12;338:a3006. doi: 10.1136/bmj.a3006.
PubMed 19139138
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Care & Patient Navigators for Latinos With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT02469714
- Acronym / sponsor ID
- PCORI-AD1306-01419
- Conditions
- Mental Disorders
- Keywords
- Patient Navigator, Integrated Care, Latino, Mental health and wellness, Physical health and wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Illinois Institute of TechnologyUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Trilogy Inc. Behavioral Healthcare
- Study start
- Aug 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Posted 23 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The health care needs of people with serious mental illness are exacerbated by ethnic health disparities. Latinos with serious mental illness show significant health problems compared to other ethnic groups. Therefore, this project is to develop a meaningful peer-navigator program for Latinos with serious mental illness using community-based participatory research (CBPR). Investigators are currently working with seven Hispanic/Latinos with a mental illness that have formed a Consumer Research Team (CRT) that will guide this project. This project will identify and define the problem by conducting a mixed methods research thru qualitative interviews with various stakeholders defined by the investigator's CRT group. The qualitative findings will then be cross-validated in a quantitative survey by 100 Hispanic/Latinos with mental illness. This information will then be used to design an intervention using an integrated care model for Peer-Navigators. Feasibility, accessibility , acceptability and impact of the peer-navigator program will be then evaluated in a randomized control trial (RCT) with 100 Latinos with serious mental illness who will complete measures of physical health, mental health, service use and engagement at baseline, 4, 8, and 12 months. Investigators expect to show physical health improvement with the greater engagement observed in the peer navigator group. Investigators expect a similar improvement in mental health and quality of life as physical health concerns are diminished.
Detailed description
Latinos with serious mental illnesses have an inordinately high rate of physical illness leading to a significantly shortened life. One reason is the difficulty in engaging this disenfranchised group in primary care. Integrated services through community-based outreach and care coordination are an innovative and evidence-based practice that improves physical health. Unfortunately, social determinants of health for Latinos are often a barrier to participation in integrated care. Peer navigators offer a strategy that might help members of this group. Peer navigators, in this study, are Latinos with past history of serious mental illness specially trained to help patients meet their health needs. The program will be developed through community-based participatory research (CBPR) representing a hands-on partnership between investigators and a community advisory board made up of patient partners. Given this, investigators aim to do the following. (1) Develop a peer navigator program meant to enhance the impact of already existing integrated services for Latinos with serious mental illness. (2) Using an experimental design, test the impact of peer navigators, compared to existing integrated services alone, on engagement of Latinos with serious mental illness in primary care services. This includes indices of care seeking, appointments, and satisfaction with engagement. Investigators expect these indices to be higher in the group with peer navigators. (3) Determine the comparative impact of peer navigators versus integrated-care-as-usual on subsequent health. Investigators expect to show physical health improvement with the greater engagement observed in the peer navigator group. Investigators expect a similar improvement in mental health and quality of life as physical health concerns are diminished. This proposal represents the partnership between researchers from the Center on Adherence and Self-Determination (a National Institute of Mental Health-funded Center dedicated to understanding service engagement among people with serious mental illness and their health care system) and Trilogy. Consistent with other projects, investigators will develop a Community Advisory Board to conduct CBPR and complete a mixed-methods research project to inform the peer navigator program. Based on a power-analysis, investigators will recruit 100 Latinos with serious mental illness who will complete baseline measures of physical health, mental health, service use and engagement in the previous year, quality of life, and current housing/employment status. Patients will then be randomized to an existing integrated care program for Hispanic/Latinos with mental illness with or without peer navigators for one year. Measures will be repeated at 4, 8, and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Navigator Intervention | Experimental | Behavioral: Peer Navigator InterventionIntegrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months. |
| Controlled | No intervention | –Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Identify ethnicity as Hispanic/Latino
- Identify with experience with a mental illness
Key exclusion criteria (2 listed)
- Must be 18 years or older
- Have case manager they met on a regular basis (every week for the past 4 months) for physical health
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 |
|---|---|---|
| Peer Navigator InterventionAlso: Peer NavigatorPeer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group | Behavioural | Peer Navigator Intervention |
Primary outcome
Weekly Health Appointment Measure
Time frame: Every week for up to 52 weeks
This scale represents the total achieved appointments and total scheduled appointments. Data was collected weekly and added up per month.The minimum is 0 ( no appointments ) with no maximum (participants were not limited to the number of appointments per week).
7 secondary outcomes
Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPH)
Time frame: Baseline (0), 4, 8, and 12 months
Empowerment Scale (EMP)
Time frame: Baseline (0), 4, 8, and 12 months
Recovery Assessment Scale (RAS)
Time frame: Baseline (0), 4, 8, and 12 months
Medical Outcome Study (SF-36)
Time frame: Baseline (0), 4, 8, and 12 months
Quality of Life Scale (QLS)
Time frame: Baseline (0), 4, 8, and 12 months
Availability Health Service Scale (AHSS)
Time frame: Baseline (0), 4, 8, and 12 months
Texas Christian University Health Form- Physical Health Subscale
Time frame: Baseline (0), 4, 8, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2191833Corrigan PW. Consumer satisfaction with institutional and community care. Community Ment Health J. 1990 Apr;26(2):151-65. doi: 10.1007/BF00752392.
- Background: PubMed 8488222Corrigan PW, Jakus MR. The Patient Satisfaction Interview for partial hospitalization programs. Psychol Rep. 1993 Apr;72(2):387-90. doi: 10.2466/pr0.1993.72.2.387.
- Background: PubMed 5487612Fischer EH, Turner JL. Orientations to seeking professional help: development and research utility of an attitude scale. J Consult Clin Psychol. 1970 Aug;35(1):79-90. doi: 10.1037/h0029636. No abstract available.
- Background: PubMed 21346488Johansen R, Hestad K, Iversen VC, Agartz I, Sundet K, Andreassen OA, Melle I. Cognitive and clinical factors are associated with service engagement in early-phase schizophrenia spectrum disorders. J Nerv Ment Dis. 2011 Mar;199(3):176-82. doi: 10.1097/NMD.0b013e31820bc2f9.
- Background: PubMed 9255837Rogers ES, Chamberlin J, Ellison ML, Crean T. A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatr Serv. 1997 Aug;48(8):1042-7. doi: 10.1176/ps.48.8.1042.
- Background: PubMed 20810594Rogers ES, Ralph RO, Salzer MS. Validating the empowerment scale with a multisite sample of consumers of mental health services. Psychiatr Serv. 2010 Sep;61(9):933-6. doi: 10.1176/ps.2010.61.9.933.
- Background: PubMed 10427613Corrigan PW, Faber D, Rashid F, Leary M. The construct validity of empowerment among consumers of mental health services. Schizophr Res. 1999 Jul 27;38(1):77-84. doi: 10.1016/s0920-9964(98)00180-7.
- Background: PubMed 10401893Corrigan PW, Giffort D, Rashid F, Leary M, Okeke I. Recovery as a psychological construct. Community Ment Health J. 1999 Jun;35(3):231-9. doi: 10.1023/a:1018741302682.
- Background: PubMed 15957202Corrigan PW, Salzer M, Ralph RO, Sangster Y, Keck L. Examining the factor structure of the recovery assessment scale. Schizophr Bull. 2004;30(4):1035-41. doi: 10.1093/oxfordjournals.schbul.a007118.
- Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Background: PubMed 16047498de Vet HC, Ader HJ, Terwee CB, Pouwer F. Are factor analytical techniques used appropriately in the validation of health status questionnaires? A systematic review on the quality of factor analysis of the SF-36. Qual Life Res. 2005 Jun;14(5):1203-18; dicussion 1219-21, 1223-4. doi: 10.1007/s11136-004-5742-3.
- Background: PubMed 6838316Lehman AF. The well-being of chronic mental patients. Arch Gen Psychiatry. 1983 Apr;40(4):369-73. doi: 10.1001/archpsyc.1983.01790040023003.
- Projects led by Dr. Patrick Corrigan that address health disparitiesLink provided by the sponsor.
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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 Corrigan, Psy.D principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Navigator Intervention in people with Mental Disorders, run by Illinois Institute of Technology 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 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 23 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weekly Health Appointment Measure (time frame: Every week for up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02469714, which also lists 18 linked publications.
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 15 Mar 2024.