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

NCT00845572 | Completed DMC

• 1 other identifier: HSC20070020H
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective

Keywords

Schizophrenia; Schizoaffective; Risperdal Consta; Medication Adherence; Antipsychotic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

Consta Club

EXPERIMENTAL

Behavioral: Consta Club

Interventions

Consta Club BEHAVIORAL

Biweekly group for patients receiving Risperdal Consta injections. Each 45 minute group includes socialization time, goal-setting, illness and medication education, and refreshments.

Also known as: Risperdal Consta

Consta Club

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Schizophrenia; Medication Adherence

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dawn' I Velligan, Ph.D.

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 18, 2009
• Study Start: January 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 18, 2012

Record last verified: 2012-09

Locations

US (1)