NCT01092598

Brief Summary

Older adults with schizophrenia are a growing segment of the population yet their physical health status is poor. In order to design effective interventions, the contributing factors must be understood. Current data suggest the side effects of psychiatric medications, sociodemographic factors, and health care disparities are a few of the reasons for the poor physical health. There are only limited data on the impact of psychiatric symptomatology and neurocognition on the physical health of this population. These limited data indicate that worse symptomatology and poorer neurocognition may negatively impact physical functioning, a critical component to optimal physical health. The purpose of this pilot study is to begin to fill this knowledge gap by: 1. examining the relationship between neurocognitive function and physical function and 2. Examining the relationship between schizophrenia symptoms and physical function. 3. Examining the relationship between serum Brain Derived Neurotrophic Factor (BDNF) and physical function. Using a descriptive correlational design, 50 older adults (55+) with schizophrenia or schizoaffective disorder will be assessed. Bivariate associations will be used to examine the relationship between key variables including schizophrenia symptoms as measured by the Positive and Negative Syndrome Scale (PANSS), neurocognitive function as measured with the MATRICS Consensus Cognitive Battery (MCCB), Physical Function as measured objectively by the Timed Get Up and Go (TGUG) test and subjectively with the physical component summary subscale of the 12-item short form health survey (SF-12), and serum BDNF. These pilot data will lay the foundation for a future health promoting intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.3 years

First QC Date

March 23, 2010

Last Update Submit

May 26, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physical Function

    enrollment

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

English speaking adults older than or equal to 55 with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder that pass a capacity to consent test based on comprehension of the consent form.

You may qualify if:

  • English speaking adults older than or equal to 55 with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder that pass a capacity to consent test based on comprehension of the consent form.

You may not qualify if:

  • Non-English speaking,
  • Adults younger than 55,
  • No diagnosis of schizophrenia of schizoaffective disorder, and/or
  • Not passing a capacity to consent test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF

San Francisco, California, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 25, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2012

Study Completion

May 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations