Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dawn Velligan, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00406718
First received: November 30, 2006
Last updated: September 1, 2015
Last verified: July 2015
Results First Received: May 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Behavioral: Med-eMonitor
Behavioral: PharmCAT
Behavioral: Treatment as Usual

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
197 signed consents, but only 142 were randomized. 24 no longer wanted to participate, 15 were lost to follow up and could not be contacted, 11 did not meet inclusion criteria once documentation was reviewed, 2 moved out of the area and 3 individuals had family who did not want the individual to participate, leading them to withdraw consent.

Reporting Groups
  Description
Pharm CAT Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
Med-eMonitor

Participants will receive the Med-eMonitor™

Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed.

Treatment as Usual

standard treatment

Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.


Participant Flow:   Overall Study
    Pharm CAT     Med-eMonitor     Treatment as Usual  
STARTED     47     48     47  
COMPLETED     43     34     39  
NOT COMPLETED     4     14     8  
Withdrawal by Subject                 2                 9                 4  
Lost to Follow-up                 2                 5                 4  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
X2 for categorical, and one way anova for continuous to examine differences in demographics for participants not making it to randomization versus those randomized to treatment.

Reporting Groups
  Description
PharmCAT

Participants will receive PharmCAT

PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.

Med-eMonitor

Participants will receive the Med-eMonitor™

Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed.

Standard Treatment

Participants will receive standard treatment

Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.

Total Total of all reporting groups

Baseline Measures
    PharmCAT     Med-eMonitor     Standard Treatment     Total  
Number of Participants  
[units: participants]
  47     48     47     142  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     47     48     47     142  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  43.0  (11.04)     43.0  (10.15)     42.0  (9.27)     42.52  (10.27)  
Gender  
[units: participants]
       
Female     23     22     23     68  
Male     24     26     24     74  
Region of Enrollment  
[units: participants]
       
United States     47     48     47     142  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adherence   [ Time Frame: Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment) ]

2.  Primary:   Social and Occupational Functioning Assessment Scale (SOFAS) Scores   [ Time Frame: Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment) ]

3.  Secondary:   Schizophrenia Symptoms   [ Time Frame: Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Patients had long-standing illness and results may not apply to patients with a more recent onset of schizophrenia/schizoaffective disorder


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Dawn Velligan
Organization: UT_SanAntonio UTHSCSA
phone: 210-567-5508
e-mail: velligand@uthscsa.edu



Responsible Party: Dawn Velligan, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00406718     History of Changes
Other Study ID Numbers: R01MH074047 ( US NIH Grant/Contract Award Number )
Study First Received: November 30, 2006
Results First Received: May 1, 2015
Last Updated: September 1, 2015
Health Authority: United States: Federal Government