- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00901706
Multidimensional Assessment and Intervention for Elder Self-Neglect
June 17, 2013 updated by: Carmel Dyer, The University of Texas Health Science Center, Houston
This study is designed to assess the best method for caring for elders reported to Adult Protective Services (APS) for self-neglect.
Specifically, this study will compare APS usual care coupled with interdisciplinary comprehensive geriatric care to APS usual care alone in improving the health and quality of live among elders with substantiated self-neglect.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 65 years of age or older
- English Speaking
- Resident of Harris County, Houston Texas
- Community-dwelling
- Substantiated Self-Neglect
Exclusion Criteria:
- No other substantiated allegations
- Non-community dweller
- No available for projected follow-up period
- Impaired decision-making with no available proxy
- Already receiving care from TEAM or within the past year
- Terminal Illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CGA plus APS Usual Care
Comprehensive geriatric assessment coupled with Adult Protective Services (APS) usual care for elders with self-neglect.
|
Comprehensive Geriatric Assessment coupled with APS usual care which collectively will consist standardized cognitive, functional, affective, social, and legal interventions.
Other Names:
APS usual care consists of social, medical, and legal assistance.
Other Names:
|
|
Active Comparator: APS Usual Care
APS usual care consisting of social, medical, and legal interventions.
|
Comprehensive Geriatric Assessment coupled with APS usual care which collectively will consist standardized cognitive, functional, affective, social, and legal interventions.
Other Names:
APS usual care consists of social, medical, and legal assistance.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self-Neglect Severity Scale (SSS)
Time Frame: Baseline and 6-months
|
Baseline and 6-months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Functional Status
Time Frame: Baseline and 6-months
|
Baseline and 6-months
|
|
Kohlman Evaluation of Living Skills (KELS)
Time Frame: Baseline and 6-months
|
Baseline and 6-months
|
|
Mini-mental State Exam (MMSE)
Time Frame: Baseline and 6-months
|
Baseline and 6-months
|
|
15-item Geriatric Depression Scale
Time Frame: Baseline and 6-months
|
Baseline and 6-months
|
|
Physical Performance Test (PPT)
Time Frame: Baseline and 6-months
|
Baseline and 6-months
|
|
SF-36 Health Survey
Time Frame: Baseline and 6-months
|
Baseline and 6-months
|
|
The Duke Social Support Index (DSSI)
Time Frame: Baseline and 6-months
|
Baseline and 6-months
|
|
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Baseline and 6-months
|
Baseline and 6-months
|
|
Costs of Social Services and Health Care Utilization and Costs
Time Frame: Months 1,2,3,4,5,6
|
Months 1,2,3,4,5,6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carmel B. Dyer, MD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
May 12, 2009
First Submitted That Met QC Criteria
May 13, 2009
First Posted (Estimate)
May 14, 2009
Study Record Updates
Last Update Posted (Estimate)
June 18, 2013
Last Update Submitted That Met QC Criteria
June 17, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC-MS-08-0052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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