Trial · NCT01152697
Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic
NCT01152697, Not applicable, Completed, University Hospitals Cleveland Medical Center; results first posted 2014-06-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic. Trials, record NCT01152697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01152697
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic
- NCT number
- NCT01152697
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 30 participants, actual
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Conditions
- Patient Noncompliance
- Interventions
- haloperidol decanoate, haloperidol, Customized Adherence Enhancement
- First posted
- 2010-06-29
- Last updated
- 2014-12-30
- Results first posted
- 2014-06-04
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks | Baseline-25 weeks | 26 participants were asked how many days they were homeless at week 25. Only data for these participants was analyzed for change from baseline to week 25. | days | MEAN |
| PRIMARY | Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks | Baseline-25 weeks | 17 participants were administered and completed measurement of their Treatment Adherence scores at week 25. Only data for these participants was analyzed for change from baseline to week 25. | Percentage of doses | MEAN |
| PRIMARY | Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks | Baseline-25 weeks | 15 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change from baseline to week 25. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks | Baseline-25 weeks | 16 participants were administered and completed measurement with the Morisky Medication Rating Scale at week 25. Only data for these participants was analyzed for change from baseline to week 25. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks | Baseline-25 weeks | 19 participants were administered and completed measurement with the AMQ at week 25. Only data for these participants was analyzed for change from baseline to week 25. Lower scores indicate improved outcomes. | units on a scale | MEAN |
| SECONDARY | Frequency of Health Resource Use Throughout Months 10, 11, and 12 | Month 1-3, Month 10-12 | Three participants were administered and completed this measurement at 12 months. Only data for these participants was analyzed for changes. | days | MEAN |
| SECONDARY | Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks | Baseline-25 weeks | 19 participants were administered and completed measurement with the BPRS at week 25. Only data for these participants was analyzed for change from baseline to week 25. | units on a scale | MEAN |
| SECONDARY | Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks | Baseline-25 weeks | 17 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change at week 25. | units on a scale | MEAN |
| SECONDARY | Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks | Baseline-25 weeks | 17 participants were administered and completed measurement with the SOFAS at week 25. Only data for these participants was analyzed for change from baseline to week 25. | units on a scale | MEAN |
| SECONDARY | Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks | 25 weeks | 17 participants were administered and completed this measure at week 25. | units on a scale | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks | Patient Noncompliance | Baseline | 6.50 | Standard Deviation 7.73 | days |
| Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks | Patient Noncompliance | 25 Weeks | 9.85 | Standard Deviation 13.96 | days |
| Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks | Patient Noncompliance | Past week | 30.91 | Standard Deviation 34.50 | Percentage of doses |
| Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks | Patient Noncompliance | Past month | 10.10 | Standard Deviation 16.70 | Percentage of doses |
| Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks | Patient Noncompliance | Baseline | 7.47 | Standard Deviation 1.84 | units on a scale |
| Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks | Patient Noncompliance | Week 25 | 8.07 | Standard Deviation 1.03 | units on a scale |
| Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks | Patient Noncompliance | Baseline | 2.31 | Standard Deviation 1.20 | units on a scale |
| Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks | Patient Noncompliance | Week 25 | 1.19 | Standard Deviation 1.47 | units on a scale |
| Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks | Patient Noncompliance | Baseline | 6.63 | Standard Deviation 3.44 | units on a scale |
| Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks | Patient Noncompliance | Week 25 | 4.47 | Standard Deviation 3.29 | units on a scale |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patient Noncompliance | 30 | |
| Overall Study | COMPLETED | Patient Noncompliance | 11 | |
| Overall Study | NOT COMPLETED | Patient Noncompliance | 19 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Abnormal EKG | Cardiac disorders | Patient Noncompliance | 1 | 30 | 1 |
| serious | Stomach Cramps | Gastrointestinal disorders | Patient Noncompliance | 1 | 30 | 1 |
| serious | High Blood Pressure | Cardiac disorders | Patient Noncompliance | 1 | 30 | 1 |
| serious | Toothache and Infection | Infections and infestations | Patient Noncompliance | 1 | 30 | 1 |
| serious | Infection in Leg | Infections and infestations | Patient Noncompliance | 1 | 30 | 1 |
| serious | Complications from Colostomy Surgery | Infections and infestations | Patient Noncompliance | 1 | 30 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patient Noncompliance | ||
| Total, other adverse events | Patient Noncompliance | 0 | 30 |
| Total, serious adverse events | Patient Noncompliance | 6 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24434094 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01152697
GET https://conductscience.org/api/trials/v1/NCT01152697/results?page=2