The Consta Club: A Demonstration Project for Setting up a Consta Club in a Community Mental Health Center

Schizophrenia Clinical Trial

Official title:

The Consta Club: A Demonstration Project for Setting up a Consta Club in a Community Mental Health Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845572
• Other study ID #: HSC20070020H
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: September 17, 2012
• Start date: January 2007
• Est. completion date: June 2010

Study information

• Verified date: September 2012
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Males and females who are able to understand the consent form and who have given informed consent.

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:

1. History of significant head trauma, seizure disorder, or mental retardation.

2. Has a legal guardian.

3. Alcohol or drug abuse or dependence within the past 3 months.

4. Previous negative reactions to oral Risperdal.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizoaffective
• Schizophrenia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Ortho-McNeil Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		end of study	No
Secondary	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		end of study	No