Trial · NCT01152697
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks | Baseline-25 weeks | Subjects will be asked how many days they have been homeless |
| Primary | Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks | 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. |
| Primary | Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks | Baseline-25 weeks | Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes. |
| Primary | Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks | Baseline-25 weeks | Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes. |
| Primary | Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks | Baseline-25 weeks | Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes. |
| Secondary | Frequency of Health Resource Use Throughout Months 10, 11, and 12 | Month 1-3, Month 10-12 | The frequency of health resource use will be measured through interview of the participant. |
| Secondary | Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks | Baseline-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. |
| Secondary | Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks | Baseline-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) |
| Secondary | Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks | Baseline-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. |
| Secondary | Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks | 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. |
| Secondary | Change in Schizophrenia and Schizoaffective Disorder Symptom Severity Scale as Measured by the Positive and Negative Syndrome Scale (PANSS) at 25 Weeks | Baseline-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. |
| Secondary | Frequency of Health Resource Use in the Past 3 Months as Measured at 25 Weeks | 25 weeks | The frequency of health resource use will be measured through interview of the participant. |
| Secondary | Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 12 Months | 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) |
| Secondary | Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 12 Months | Baseline-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. |
| Secondary | Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 12 Months | 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. |
| Secondary | Days Homeless Out of the Previous 6 Months as Measured at 12 Months | 12 months | Subjects will be asked how many days they have been homeless |
| Secondary | Treatment Adherence Score as Measured at 12 Months | 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. |
| Secondary | Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 12 Months | 12 months | Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes. |
| Secondary | Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 12 Months | 12 months | Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate better outcomes. |
| Secondary | Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 12 Months | 12 months | Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01152697/registered