NCT00224380

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2003

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
Last Updated

September 23, 2009

Status Verified

September 1, 2009

First QC Date

September 15, 2005

Last Update Submit

September 22, 2009

Conditions

Keywords

Serious mental illnessmedication adherence

Outcome Measures

Primary Outcomes (1)

  • Medication adherence based on pill counts

Secondary Outcomes (1)

  • Medication management ability

Interventions

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Council of Nashua

Nashua, New Hampshire, 03063, United States

Location

MeSH Terms

Conditions

SchizophreniaBipolar DisorderDepressionMedication Adherence

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersBehavioral SymptomsBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Sarah I Pratt, PhD

    Assistant Professor in Psychiatry, Dartmouth Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 23, 2005

Study Start

July 1, 2003

Study Completion

February 1, 2005

Last Updated

September 23, 2009

Record last verified: 2009-09

Locations