The Consta Club: A Demonstration Project for Setting up a Consta Club in a Community Mental Health Center
NCT ID: NCT00845572
Last Updated: 2012-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2007-01-31
2010-06-30
Brief Summary
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Detailed Description
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We have established a thirty minute bi-weekly Consta Club in which individuals will attend a social group and and also receive their injection of Risperdal Consta. Consta Club will educate individuals about the importance of medication adherence as well as establish a routine that facilitates adherence. The club will provide the opportunity for the club members to discuss their mental illness, develop goals to recovery, establish a means of transportation to the club and participate in drawings to win prizes. The overall hypothesis is that the individuals in Consta Club will experience a decrease in walk-in visits, emergency procedures and hospitalizations. It is also hypothesized that individuals in Consta Club will demonstrate lower levels of symptomatology, higher levels of quality of life and improvements in functioning when compared to their baseline.
A total of twenty-five individuals will be recruited to switch from an oral atypical antipsychotic medication to Risperdal Consta which will be supplied by Janssen Pharmaceutica at no cost to the individual or the clinic. Individuals will be recruited prior to hospital discharge if inpatient at time of recruitment OR from the local mental health clinic. Hospitalized individuals will be started on Risperdal Consta prior to discharge and outpatients will switch from oral atypical antipsychotics within two weeks. Individuals will be receiving a single injection of Risperdal Consta every two weeks. Prior to the switch and every 3 months for a period of 9 months the individual will be assessed.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Consta Club
Consta Club
Biweekly group for patients receiving Risperdal Consta injections. Each 45 minute group includes socialization time, goal-setting, illness and medication education, and refreshments.
Interventions
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Consta Club
Biweekly group for patients receiving Risperdal Consta injections. Each 45 minute group includes socialization time, goal-setting, illness and medication education, and refreshments.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Between the ages of 18 and 65.
3. Diagnosis of schizophrenia or schizoaffective disorder
4. Receiving treatment with an oral atypical antipsychotic medication for at least two months prior to study
5. Only partial adherence (80% or less) to antipsychotic medication
6. If they have tried Consta but did not receive an adequate trial and did not experience any adverse symptoms.
7. Some responsibility for attending Consta Club meetings and injections.
8. Able to understand and complete rating scales.
Exclusion Criteria
2. Has a legal guardian.
3. Alcohol or drug abuse or dependence within the past 3 months.
4. Previous negative reactions to oral Risperdal.
18 Years
65 Years
ALL
No
Sponsors
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Ortho-McNeil Janssen Scientific Affairs, LLC
INDUSTRY
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Dawn' I Velligan, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Locations
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University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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HSC20070020H
Identifier Type: -
Identifier Source: org_study_id