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Medication Adherence in Older Adults With Serious Mental Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00224380
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : September 23, 2009
Sponsor:
Collaborators:
Janssen, LP
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Dartmouth-Hitchcock Medical Center

Brief Summary:

The goal of this pilot study is to learn about how well older people with serious mental illness (including schizophrenia, schizoaffective disorder, bipolar disorder, major depression) follow prescribed medication regimens, and to evaluate a manualized intervention designed to enhance medication management skills and adherence, the Using Medications Effectively program. The following four hypotheses will be tested:

  1. Medication adherence will be associated with several variables including insight, memory, medication management skill, knowledge about medications, attitudes about medications.
  2. People who receive the program will have better medication adherence compared to those who do not receive the program as measured by pill counts.
  3. People who receive the program will develop better medication management skills compared to those who do not receive the program.

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Depression Behavioral: Using Medications Effectively Not Applicable

Detailed Description:
Individuals who are already participating in a study of a combined skills training and health care management intervention for older people with serious mental illness are invited to join this study. Half of the individuals have already been randomly assigned to receive the intervention and half have already been randomly assigned to continue receiving their usual care. The people receiving the intervention receive the skills training module, Using Medications Effectively, in 8 group sessions over 8 weeks. The module includes information about common medications used for psychiatric and medical illnesses; training on using devices to help take medications properly; and instruction on strategies to help incorporate medication taking into a daily routine. A trained research assistant conducts pill counts and interview sessions with all participants after they sign an informed consent form, 8 weeks later, and 3 months after the second interview.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: Medication Adherence in Older Adults
Study Start Date : July 2003
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders




Primary Outcome Measures :
  1. Medication adherence based on pill counts

Secondary Outcome Measures :
  1. Medication management ability


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participation in Rehabilitation and Health Care for Older People with SMI Serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, major depression) and functional impairment Receiving mental health services for 3 months or more Age 50 or older Ability to provide informed consent or guardian consent -

Exclusion Criteria:

Currently residing in an institution Psychiatric illness caused by co-morbid medical condition Dementia or score<20 on Mini Mental State Exam

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224380


Locations
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United States, New Hampshire
Community Council of Nashua
Nashua, New Hampshire, United States, 03063
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Janssen, LP
National Alliance for Research on Schizophrenia and Depression
Investigators
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Principal Investigator: Sarah I Pratt, PhD Assistant Professor in Psychiatry, Dartmouth Medical School

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ClinicalTrials.gov Identifier: NCT00224380    
Other Study ID Numbers: MA200316456
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: September 23, 2009
Last Verified: September 2009
Keywords provided by Dartmouth-Hitchcock Medical Center:
Serious mental illness
medication adherence
Additional relevant MeSH terms:
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Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders