The Consta Club: A Demonstration Project for Setting up a Consta Club in a Community Mental Health Center
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Consta Club: A Demonstration Project for Setting up a Consta Club in a Community Mental Health Center|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
|Experimental: Consta Club||
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.
Other Name: Risperdal Consta
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845572
|United States, Texas|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Dawn` I Velligan, Ph.D.||University of Texas|