DepressionNCT00012740
A Casefinding and Referral System for Older Veterans Within Primary Care
A study testing Casefinding and Referral System in people with Depression and Incontinence, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Underdiagnosis and undertreatment of elderly persons remains a widespread problem. While many innovative geriatric care programs exist within VHA, we still lack a systematic process for identifying at-risk elders from the larger VA population who are likely to benefit from specialized geriatric services. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Incontinence, Cognitive Impairment
- What is being tested?
- Casefinding and Referral System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 792 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Sep 2001
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subjects have to have a score of 4 or higher in a screening questionnaire and have been seen at clinic in the past 18 months.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
About this study
Underdiagnosis and undertreatment of elderly persons remains a widespread problem. While many innovative geriatric care programs exist within VHA, we still lack a systematic process for identifying at-risk elders from the larger VA population who are likely to benefit from specialized geriatric services.
Read the detailed description
Background:
Underdiagnosis and undertreatment of elderly persons remains a widespread problem. While many innovative geriatric care programs exist within VHA, we still lack a systematic process for identifying at-risk elders from the larger VA population who are likely to benefit from specialized geriatric services.
Objectives:
Our goal is to improve care for at-risk older veterans through a comprehensive system of casefinding, assessment, referral and follow-up within the primary care setting. We hypothesize that subjects receiving this intervention will have more complete evaluation and treatment for selected geriatric conditions (i.e., falls, urinary incontinence, functional status impairments, depression, and cognitive deficits), better continuity of care, less decline in functional status, and better general health than subjects receiving usual care.
Methods:
This randomized controlled trial is being performed at the Sepulveda VA Outpatient Clinic. The study sample is composed of community-dwelling veterans aged 65 and older who are not receiving VA geriatric services. Veterans are mailed a health screening survey to identify those at risk for decline based on criteria established in pilot work. At-risk respondents who are in the intervention group receive a structured telephone assessment (casefinding) and referral to appropriate geriatric services, including a geriatric assessment and teaching clinic integrated with primary care, and telephone case management. Subjects in the control group receive usual care. Major outcome measures collected by telephone interview at baseline, 12, 24, and 36 months include functional status, self-rated health, satisfaction, and health care utilization. Medical records are reviewed for evidence of evaluation and treatment of the target conditions.
Status:
Data collection for this project was completed on September 30, 2001. The subject recruitment phase was completed in August, 1998. Collection of 36 month follow-up data has been completed for all subjects enrolled. Data analysis and preparation of publication is in press.
- Conditions
- Depression, Incontinence, Cognitive Impairment
- Being tested
- Casefinding and Referral System
- Medical subject headings
- Depression, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casefinding and Referral SystemBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Casefinding and Referral System |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionSep 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 792 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Laurence Z. Rubenstein, MD MPH, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CACathy A. Alessi, MD, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012740
- Sponsor's protocol ID
- IIR 95-050
- Status last verified
- Dec 2005
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Alessi CA, Josephson KR, Harker JO, Pietruszka FM, Hoyl MT, Rubenstein LZ. The yield, reliability, and validity of a postal survey for screening community-dwelling older people. J Am Geriatr Soc. 2003 Feb;51(2):194-202. doi: 10.1046/j.1532-5415.2003.51058.x.
PubMed 12558716Hoyl MT, Alessi CA, Harker JO, Josephson KR, Pietruszka FM, Koelfgen M, Mervis JR, Fitten LJ, Rubenstein LZ. Development and testing of a five-item version of the Geriatric Depression Scale. J Am Geriatr Soc. 1999 Jul;47(7):873-8. doi: 10.1111/j.1532-5415.1999.tb03848.x.
PubMed 10404935
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Casefinding and Referral System for Older Veterans Within Primary Care
- ClinicalTrials.gov ID
- NCT00012740
- Acronym / sponsor ID
- IIR 95-050
- Conditions
- Depression, Incontinence, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 792 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Sep 2001 (actual)
- First posted
- 16 Mar 2001 (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.
Underdiagnosis and undertreatment of elderly persons remains a widespread problem. While many innovative geriatric care programs exist within VHA, we still lack a systematic process for identifying at-risk elders from the larger VA population who are likely to benefit from specialized geriatric services.
Detailed description
Background:
Underdiagnosis and undertreatment of elderly persons remains a widespread problem. While many innovative geriatric care programs exist within VHA, we still lack a systematic process for identifying at-risk elders from the larger VA population who are likely to benefit from specialized geriatric services.
Objectives:
Our goal is to improve care for at-risk older veterans through a comprehensive system of casefinding, assessment, referral and follow-up within the primary care setting. We hypothesize that subjects receiving this intervention will have more complete evaluation and treatment for selected geriatric conditions (i.e., falls, urinary incontinence, functional status impairments, depression, and cognitive deficits), better continuity of care, less decline in functional status, and better general health than subjects receiving usual care.
Methods:
This randomized controlled trial is being performed at the Sepulveda VA Outpatient Clinic. The study sample is composed of community-dwelling veterans aged 65 and older who are not receiving VA geriatric services. Veterans are mailed a health screening survey to identify those at risk for decline based on criteria established in pilot work. At-risk respondents who are in the intervention group receive a structured telephone assessment (casefinding) and referral to appropriate geriatric services, including a geriatric assessment and teaching clinic integrated with primary care, and telephone case management. Subjects in the control group receive usual care. Major outcome measures collected by telephone interview at baseline, 12, 24, and 36 months include functional status, self-rated health, satisfaction, and health care utilization. Medical records are reviewed for evidence of evaluation and treatment of the target conditions.
Status:
Data collection for this project was completed on September 30, 2001. The subject recruitment phase was completed in August, 1998. Collection of 36 month follow-up data has been completed for all subjects enrolled. Data analysis and preparation of publication is in press.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Casefinding and Referral System |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Subjects have to have a score of 4 or higher in a screening questionnaire and have been seen at clinic in the past 18 months.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Casefinding and Referral System | Behavioural | Arm 1 |
Primary outcome
Not reported in the source record.
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 7 Apr 2015.
- Results publication: PubMed 12558716Alessi CA, Josephson KR, Harker JO, Pietruszka FM, Hoyl MT, Rubenstein LZ. The yield, reliability, and validity of a postal survey for screening community-dwelling older people. J Am Geriatr Soc. 2003 Feb;51(2):194-202. doi: 10.1046/j.1532-5415.2003.51058.x.
- Results publication: PubMed 10404935Hoyl MT, Alessi CA, Harker JO, Josephson KR, Pietruszka FM, Koelfgen M, Mervis JR, Fitten LJ, Rubenstein LZ. Development and testing of a five-item version of the Geriatric Depression Scale. J Am Geriatr Soc. 1999 Jul;47(7):873-8. doi: 10.1111/j.1532-5415.1999.tb03848.x.
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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.
Laurence Z. Rubenstein, MD MPH principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Cathy A. Alessi, MD principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casefinding and Referral System in people with Depression and Incontinence, run by US Department of Veterans Affairs 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 0 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 7 Apr 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00012740, which also lists 2 linked publications.
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 7 Apr 2015.