Medication Adherence in Older Adults With Serious Mental Illness

Depression Clinical Trial

Official title:

Medication Adherence in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224380
• Other study ID #: MA200316456
• Status: Completed
• Phase: N/A
• First received: September 15, 2005
• Last updated: September 22, 2009
• Start date: July 2003
• Est. completion date: February 2005

Study information

• Verified date: September 2009
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Schizophrenia

Intervention

Behavioral:
• Using Medications Effectively

Locations

Country	Name	City	State
United States	Community Council of Nashua	Nashua	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Janssen, LP, National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence based on pill counts
Secondary	Medication management ability