SchizophreniaNCT01092598
Factors Association With Poor Physical Function in Older Adults With Schizophrenia
An observational study of Schizophrenia and Schizoaffective Disorder, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Non-English speaking,
- Adults younger than 55,
- No diagnosis of schizophrenia of schizoaffective disorder, and/or
- Not passing a capacity to consent test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Neurocognition and Symptomatology on Physical Function Among Older Adults With Schizophrenia
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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function
Measured: enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2012
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092598
- Sponsor's protocol ID
- H54355-35547-O1
- Status last verified
- May 2015
- First submitted
- 23 Mar 2010
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Neurocognition and Symptomatology on Physical Function Among Older Adults With Schizophrenia
- ClinicalTrials.gov ID
- NCT01092598
- Acronym / sponsor ID
- H54355-35547-O1
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Mar 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Non-English speaking,
- Adults younger than 55,
- No diagnosis of schizophrenia of schizoaffective disorder, and/or
- Not passing a capacity to consent test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical Function
Time frame: enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Function (time frame: enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.