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

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00845572
First received: February 17, 2009
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Schizophrenia
Schizoaffective
Behavioral: Consta Club

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

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 [ Time Frame: end of study ] [ Designated as safety issue: No ]

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 [ Time Frame: end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845572

Locations
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
Principal Investigator: Dawn` I Velligan, Ph.D. University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00845572     History of Changes
Other Study ID Numbers: HSC20070020H
Study First Received: February 17, 2009
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Schizophrenia
Schizoaffective
Risperdal Consta
Medication Adherence
Antipsychotic

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014