Patient NoncomplianceCAE-LNCT01152697
Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic
A study testing haloperidol decanoate, haloperidol and Customized Adherence Enhancement in people with Patient Noncompliance, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%. Inadequate adherence is associated with poor outcomes such as relapse, homelessness, hospitalization, and increased health care costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Noncompliance
- What is being tested?
- haloperidol decanoate, haloperidol and Customized Adherence Enhancement
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2012
- 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
- Individuals age 18 years old and older with schizophrenia or schizoaffective disorder as confirmed by the Mini International Psychiatric Inventory (MINI).
- Individuals who are currently or have been recently homeless (within the past 12 months) as per the official federal definition of homelessness.
- Known to have medication treatment adherence (20% or more missed medications in past week or past month) problems as identified by the Treatment Routines Questionnaire patient or clinician versions (TRQ-P/TRQ-C).
- Ability to be rated on psychiatric rating scales.
- Willingness to take long-acting injectable medication.
- Currently receiving treatment at a Community Mental Health Clinic (CMHC) or another mental health treatment provider who is able to provide continuity of care during and after study participation.
- Able to provide written, informed consent to study participation.
- Women of child-bearing potential must be utilizing reliable, medically-accepted methods of birth control.
Who cannot join
- Known resistance or intolerance to haloperidol or haloperidol decanoate.
- Medical contraindication to haloperidol or haloperidol decanoate.
- Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment.
- Prior or current treatment with clozapine.
- Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial.
- Current substance dependence.
Show all 9Show fewer
- High risk of harm to self or others.
- Female who is currently pregnant or breastfeeding.
- Individual who is already in permanent and supported housing that includes comprehensive mental health services (e.g. Housing First).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Trial of Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (CAE-L) in Individuals With Schizophrenia or Schizoaffective Disorder at Risk for Treatment Non-adherence and for Homelessness
Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%. Inadequate adherence is associated with poor outcomes such as relapse, homelessness, hospitalization, and increased health care costs. Studies have shown a direct correlation between non-adherence and rates of relapse in schizophrenia; on average, non-adherent patients have a risk of relapse that is 3.7 times greater than their adherent counterparts. A major obstacle to good outcomes in the maintenance treatment of patients with severe mental illness is difficulty with medication routines on an on-going basis. For this reason, long-acting injectable antipsychotic medication is a particularly attractive treatment option for populations with schizophrenia and schizoaffective disorder, although it is unlikely that medication treatment alone is likely to modify long-term attitudes and behaviors.
This prospective study is a pilot analysis of a combined approach which merges a psychosocial intervention to optimize treatment attitudes towards psychotropic medication (CAE) and long-acting injectable antipsychotic medication (L) in recently homeless individuals with schizophrenia or schizoaffective disorder who are known to have on-going difficulties with treatment non-adherence. It is expected that this combined approach (CAE-L) will improve illness outcomes among the most vulnerable of populations with schizophrenia or schizoaffective disorder.
- Conditions
- Patient Noncompliance
- Being tested
- haloperidol decanoate, haloperidol, Customized Adherence Enhancement
- Keywords
- nonadherence, noncompliance, homeless, schizophrenia, schizoaffective
- Medical subject headings
- Patient Compliance, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
haloperidol decanoateDrug
Drug is in in injectable form and will be administered approximately every four weeks through Week 25 of the study. A participant may continue on the drug after Week 25 at the discretion of his or her treating psychiatrist. Dosage is per package insert or at the discretion of the psychiatrist.
haloperidolDrug
Drug will be administered in oral form to participants not already taking oral haloperidol and then transitioned to the injectable version. Dosage and frequency is at the discretion of the psychiatrist.
Customized Adherence EnhancementBehavioural
CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers).
| Study group | Role | What they receive |
|---|---|---|
| Patient Noncompliance | Experimental | There was only one arm for this study. Receives: Drug: haloperidol decanoate; Drug: haloperidol; Behavioral: Customized Adherence Enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks
Subjects will be asked how many days they have been homeless
Measured: Baseline-25 weeks
Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks
A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.
Measured: Baseline-25 weeks
Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks
Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.
Measured: Baseline-25 weeks
Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks
Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.
Measured: Baseline-25 weeks
Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks
Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.
Measured: Baseline-25 weeks
Secondary outcomes (15)
Frequency of Health Resource Use Throughout Months 10, 11, and 12
The frequency of health resource use will be measured through interview of the participant.
Measured: Month 1-3, Month 10-12
Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks
The BPRS, developed by Overall and Gorham (1962), is a widely used, relatively brief scale that measures major psychotic and non-psychotic symptoms in individuals with SMI. The 18-item BPRS is well-validated and is perhaps the most researched instrument in psychiatry. Reliability coefficients are reported to be in the range of 0.56-0.87.
Scale Range: 18-126 Lower scores represent improved outcomes.
Measured: Baseline-25 weeks
Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks
Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.
Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)
Measured: Baseline-25 weeks
Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks
Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.
Measured: Baseline-25 weeks
Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks
Satisfaction will be measured by a seven item inventory taken by the participant.
Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35.
Measured: 25 weeks
Change in Schizophrenia and Schizoaffective Disorder Symptom Severity Scale as Measured by the Positive and Negative Syndrome Scale (PANSS) at 25 Weeks
The PANSS (Kay, Fiszbein, \& Opler 1987) was created to assess both the positive and negative symptoms of schizophrenia such as hallucinations and emotional withdrawal, respectively. The scale rates 30 symptoms on a scale from 1 (absent) to 7 (extreme) and has been shown to limit bias between the assessment of positive and negative symptoms, providing a broad but balanced spectrum of the illness.
There are three subscales: positive symptoms, negative symptoms, general psychopathology. Potential responses to Items on all subscales range from 1 (absent) to 7 (extreme). Lower scores indicate lower symptoms and, therefore, better outcomes. Higher scores indicate more presence of symptoms and, therefore, worse outcomes.
Subscales are combined to produce a total score, which is summed from all of the subscales. Lower total scores indicate lower symptoms and, therefore, better outcomes. Higher total scores indicate more presence of symptoms and, therefore, worse outcomes.
Measured: Baseline-25 weeks
Frequency of Health Resource Use in the Past 3 Months as Measured at 25 Weeks
The frequency of health resource use will be measured through interview of the participant.
Measured: 25 weeks
Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 12 Months
Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.
Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)
Measured: 12 months
Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 12 Months
Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF. The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.
Measured: Baseline-12 months
Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 12 Months
Satisfaction will be measured by a seven item inventory taken by the participant.
Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35.
Measured: 12 months
Days Homeless Out of the Previous 6 Months as Measured at 12 Months
Subjects will be asked how many days they have been homeless
Measured: 12 months
Treatment Adherence Score as Measured at 12 Months
A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.
Measured: 12 months
Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 12 Months
Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.
Measured: 12 months
Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 12 Months
Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate better outcomes.
Measured: 12 months
Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 12 Months
Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2012
- Study completionAug 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for Patient NoncomplianceStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University
- Responsible party
- Principal investigator, Martha Sajatovic, University Hospitals Cleveland Medical Center
- Investigators
- Martha Sajatovic, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152697
- Sponsor's protocol ID
- Reuter-L1473
- Acronym
- CAE-L
- Status last verified
- Dec 2014
- First submitted
- 24 Jun 2010
- Last updated
- 30 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sajatovic M, Levin J, Ramirez LF, Hahn DY, Tatsuoka C, Bialko CS, Cassidy KA, Fuentes-Casiano E, Williams TD. Prospective trial of customized adherence enhancement plus long-acting injectable antipsychotic medication in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2013 Dec;74(12):1249-55. doi: 10.4088/JCP.12m08331.
PubMed 24434094
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (CAE-L) in Individuals With Schizophrenia or Schizoaffective Disorder at Risk for Treatment Non-adherence and for Homelessness
- ClinicalTrials.gov ID
- NCT01152697
- Acronym / sponsor ID
- CAE-L / Reuter-L1473
- Conditions
- Patient Noncompliance
- Keywords
- nonadherence, noncompliance, homeless, schizophrenia, schizoaffective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Case Western Reserve University
- Study start
- Jun 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Posted 4 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%. Inadequate adherence is associated with poor outcomes such as relapse, homelessness, hospitalization, and increased health care costs. Studies have shown a direct correlation between non-adherence and rates of relapse in schizophrenia; on average, non-adherent patients have a risk of relapse that is 3.7 times greater than their adherent counterparts. A major obstacle to good outcomes in the maintenance treatment of patients with severe mental illness is difficulty with medication routines on an on-going basis. For this reason, long-acting injectable antipsychotic medication is a particularly attractive treatment option for populations with schizophrenia and schizoaffective disorder, although it is unlikely that medication treatment alone is likely to modify long-term attitudes and behaviors.
This prospective study is a pilot analysis of a combined approach which merges a psychosocial intervention to optimize treatment attitudes towards psychotropic medication (CAE) and long-acting injectable antipsychotic medication (L) in recently homeless individuals with schizophrenia or schizoaffective disorder who are known to have on-going difficulties with treatment non-adherence. It is expected that this combined approach (CAE-L) will improve illness outcomes among the most vulnerable of populations with schizophrenia or schizoaffective disorder.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Noncompliance | Experimental | Drug: haloperidol decanoate, Drug: haloperidol, Behavioral: Customized Adherence EnhancementThere was only one arm for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals age 18 years old and older with schizophrenia or schizoaffective disorder as confirmed by the Mini International Psychiatric Inventory (MINI).
- Individuals who are currently or have been recently homeless (within the past 12 months) as per the official federal definition of homelessness.
- Known to have medication treatment adherence (20% or more missed medications in past week or past month) problems as identified by the Treatment Routines Questionnaire patient or clinician versions (TRQ-P/TRQ-C).
- Ability to be rated on psychiatric rating scales.
- Willingness to take long-acting injectable medication.
Key exclusion criteria (9 listed)
- Known resistance or intolerance to haloperidol or haloperidol decanoate.
- Medical contraindication to haloperidol or haloperidol decanoate.
- Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment.
- Prior or current treatment with clozapine.
- Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial.
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 |
|---|---|---|
| haloperidol decanoateDrug is in in injectable form and will be administered approximately every four weeks through Week 25 of the study. A participant may continue on the drug after Week 25 at the discretion of his or her treating psychiatrist. Dosage is per package insert or at the discretion of the psychiatrist. | Drug | Patient Noncompliance |
| haloperidolDrug will be administered in oral form to participants not already taking oral haloperidol and then transitioned to the injectable version. Dosage and frequency is at the discretion of the psychiatrist. | Drug | Patient Noncompliance |
| Customized Adherence EnhancementCAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers). | Behavioural | Patient Noncompliance |
Primary outcome
Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks
Time frame: Baseline-25 weeks
Subjects will be asked how many days they have been homeless
Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks
Time frame: Baseline-25 weeks
A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.
Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks
Time frame: Baseline-25 weeks
Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.
Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks
Time frame: Baseline-25 weeks
Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.
Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks
Time frame: Baseline-25 weeks
Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.
15 secondary outcomes
Frequency of Health Resource Use Throughout Months 10, 11, and 12
Time frame: Month 1-3, Month 10-12
Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks
Time frame: Baseline-25 weeks
Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks
Time frame: Baseline-25 weeks
Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks
Time frame: Baseline-25 weeks
Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks
Time frame: 25 weeks
Change in Schizophrenia and Schizoaffective Disorder Symptom Severity Scale as Measured by the Positive and Negative Syndrome Scale (PANSS) at 25 Weeks
Time frame: Baseline-25 weeks
Frequency of Health Resource Use in the Past 3 Months as Measured at 25 Weeks
Time frame: 25 weeks
Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 12 Months
Time frame: 12 months
Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 12 Months
Time frame: Baseline-12 months
Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 12 Months
Time frame: 12 months
Days Homeless Out of the Previous 6 Months as Measured at 12 Months
Time frame: 12 months
Treatment Adherence Score as Measured at 12 Months
Time frame: 12 months
Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 12 Months
Time frame: 12 months
Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 12 Months
Time frame: 12 months
Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24434094Sajatovic M, Levin J, Ramirez LF, Hahn DY, Tatsuoka C, Bialko CS, Cassidy KA, Fuentes-Casiano E, Williams TD. Prospective trial of customized adherence enhancement plus long-acting injectable antipsychotic medication in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2013 Dec;74(12):1249-55. doi: 10.4088/JCP.12m08331.
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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.
Martha Sajatovic, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing haloperidol decanoate, haloperidol and Customized Adherence Enhancement in people with Patient Noncompliance, run by University Hospitals Cleveland Medical Center 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 8 inclusion and 9 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 30 Dec 2014. 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 4 Jun 2014). 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?
Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks (time frame: Baseline-25 weeks). The study lists 5 primary outcomes in all. 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 NCT01152697, which also lists 1 linked publication.
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 30 Dec 2014.