The Consta Club: A Demonstration Project for Setting up a Consta Club in a Community Mental Health Center
Primary Purpose
Schizophrenia, Schizoaffective
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Consta Club
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective, Risperdal Consta, Medication Adherence, Antipsychotic
Eligibility Criteria
Inclusion Criteria:
- Males and females who are able to understand the consent form and who have given informed consent.
- Between the ages of 18 and 65.
- Diagnosis of schizophrenia or schizoaffective disorder
- Receiving treatment with an oral atypical antipsychotic medication for at least two months prior to study
- Only partial adherence (80% or less) to antipsychotic medication
- If they have tried Consta but did not receive an adequate trial and did not experience any adverse symptoms.
- Some responsibility for attending Consta Club meetings and injections.
- Able to understand and complete rating scales.
Exclusion Criteria:
- History of significant head trauma, seizure disorder, or mental retardation.
- Has a legal guardian.
- Alcohol or drug abuse or dependence within the past 3 months.
- Previous negative reactions to oral Risperdal.
Sites / Locations
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Consta Club
Arm Description
Outcomes
Primary Outcome Measures
Service Utilization - Patients in consta club will have fewer missed visits, fewer unscheduled visits, and fewer emergency visits and hospitalizations than matched patients on oral antipsychotics
Secondary Outcome Measures
Patients in consta club will demonstrate lower levels of symptomatology and higher levels of quality of life and community adjustment than matched patients on oral antipsychotics
Full Information
NCT ID
NCT00845572
First Posted
February 17, 2009
Last Updated
September 17, 2012
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00845572
Brief Title
The Consta Club: A Demonstration Project for Setting up a Consta Club in a Community Mental Health Center
Official Title
The Consta Club: A Demonstration Project for Setting up a Consta Club in a Community Mental Health Center
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will establish a bi-weekly Consta Club. Participants will begin taking Risperdal Consta after being recommended by their treating physician. As a part of the Consta Club attendees will receive their injection of Risperdal Consta and be educated about important mental health issues. Interviews with study participants will be completed every three months to determine the effectiveness of the change to Risperdal Consta and the bi-weekly group. The overall hypothesis is that the individuals in Consta Club will have a decrease in walk-in visits, emergency procedures and hospitalizations. It is also believed that individuals in Consta Club will have fewer symptoms and better levels of functioning.
Detailed Description
Poor adherence to oral antipsychotic medication leads to rehospitalization, derails the process of recovery, and contributes to the high cost of treating schizophrenia. Unfortunately, poor adherence is common for individuals with this diagnosis. An organizing hypothesis of our research program is that forgetfulness and failure to establish a routine that facilitates medication adherence are prominent reasons for non-adherence.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective
Keywords
Schizophrenia, Schizoaffective, Risperdal Consta, Medication Adherence, Antipsychotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Consta Club
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Consta Club
Other Intervention Name(s)
Risperdal Consta
Intervention Description
Biweekly group for patients receiving Risperdal Consta injections. Each 45 minute group includes socialization time, goal-setting, illness and medication education, and refreshments.
Primary Outcome Measure Information:
Title
Service Utilization - Patients in consta club will have fewer missed visits, fewer unscheduled visits, and fewer emergency visits and hospitalizations than matched patients on oral antipsychotics
Time Frame
end of study
Secondary Outcome Measure Information:
Title
Patients in consta club will demonstrate lower levels of symptomatology and higher levels of quality of life and community adjustment than matched patients on oral antipsychotics
Time Frame
end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females who are able to understand the consent form and who have given informed consent.
Between the ages of 18 and 65.
Diagnosis of schizophrenia or schizoaffective disorder
Receiving treatment with an oral atypical antipsychotic medication for at least two months prior to study
Only partial adherence (80% or less) to antipsychotic medication
If they have tried Consta but did not receive an adequate trial and did not experience any adverse symptoms.
Some responsibility for attending Consta Club meetings and injections.
Able to understand and complete rating scales.
Exclusion Criteria:
History of significant head trauma, seizure disorder, or mental retardation.
Has a legal guardian.
Alcohol or drug abuse or dependence within the past 3 months.
Previous negative reactions to oral Risperdal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn' I Velligan, Ph.D.
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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The Consta Club: A Demonstration Project for Setting up a Consta Club in a Community Mental Health Center
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