Self-NeglectEarly Phase 1NCT00901706
Multidimensional Assessment and Intervention for Elder Self-Neglect
A Early Phase 1 study of Self-Neglect and Cognitive Ability, General, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self-Neglect, Cognitive Ability, General, Geriatric Disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2012
- Phase
- Early Phase 1
- 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
- 65 years of age or older
- English Speaking
- Resident of Harris County, Houston Texas
- Community-dwelling
- Substantiated Self-Neglect
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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.
- Conditions
- Self-Neglect, Cognitive Ability, General, Geriatric Disorder
- Being tested
- Comprehensive Geriatric Assessment and APS Usual Care, APS usual care
- Keywords
- Self-Neglect, Comprehensive Geriatric Assessment (CGA), Geriatric Syndromes, Quality of Life, Basic Activities of Daily Living, Instrumental Activities of Daily Living
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric Assessment and APS Usual CareOther
Also called Randomized Controlled Trial
Comprehensive Geriatric Assessment coupled with APS usual care which collectively will consist standardized cognitive, functional, affective, social, and legal interventions.
APS usual careOther
Also called Randomized Controlled Trial
APS usual care consists of social, medical, and legal assistance.
| Study group | Role | What they receive |
|---|---|---|
| CGA plus APS Usual Care | Experimental | Comprehensive geriatric assessment coupled with Adult Protective Services (APS) usual care for elders with self-neglect. Receives: Other: Comprehensive Geriatric Assessment and APS Usual Care; Other: APS usual care |
| APS Usual Care | Active comparator | APS usual care consisting of social, medical, and legal interventions. Receives: Other: Comprehensive Geriatric Assessment and APS Usual Care; Other: APS usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Neglect Severity Scale (SSS)
Measured: Baseline and 6-months
Secondary outcomes (9)
Functional Status
Measured: Baseline and 6-months
Kohlman Evaluation of Living Skills (KELS)
Measured: Baseline and 6-months
Mini-mental State Exam (MMSE)
Measured: Baseline and 6-months
15-item Geriatric Depression Scale
Measured: Baseline and 6-months
Physical Performance Test (PPT)
Measured: Baseline and 6-months
SF-36 Health Survey
Measured: Baseline and 6-months
The Duke Social Support Index (DSSI)
Measured: Baseline and 6-months
Client Satisfaction Questionnaire (CSQ-8)
Measured: Baseline and 6-months
Costs of Social Services and Health Care Utilization and Costs
Measured: Months 1,2,3,4,5,6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-NeglectStudies 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
- Responsible party
- Principal investigator, Carmel Dyer, The University of Texas Health Science Center, Houston
- Investigators
- Carmel B. Dyer, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901706
- Sponsor's protocol ID
- HSC-MS-08-0052
- Status last verified
- Jun 2013
- First submitted
- 12 May 2009
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Assessment and Intervention for Elder Self-Neglect
- ClinicalTrials.gov ID
- NCT00901706
- Acronym / sponsor ID
- HSC-MS-08-0052
- Conditions
- Self-Neglect, Cognitive Ability, General, Geriatric Disorder
- Keywords
- Self-Neglect, Comprehensive Geriatric Assessment (CGA), Geriatric Syndromes, Quality of Life, Basic Activities of Daily Living, Instrumental Activities of Daily Living
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
- Study start
- Aug 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 May 2009 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGA plus APS Usual Care | Experimental | Other: Comprehensive Geriatric Assessment and APS Usual Care, Other: APS usual careComprehensive geriatric assessment coupled with Adult Protective Services (APS) usual care for elders with self-neglect. |
| APS Usual Care | Active comparator | Other: Comprehensive Geriatric Assessment and APS Usual Care, Other: APS usual careAPS usual care consisting of social, medical, and legal interventions. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65 years of age or older
- English Speaking
- Resident of Harris County, Houston Texas
- Community-dwelling
- Substantiated Self-Neglect
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Comprehensive Geriatric Assessment and APS Usual CareAlso: Randomized Controlled TrialComprehensive Geriatric Assessment coupled with APS usual care which collectively will consist standardized cognitive, functional, affective, social, and legal interventions. | Other | APS Usual Care, CGA plus APS Usual Care |
| APS usual careAlso: Randomized Controlled TrialAPS usual care consists of social, medical, and legal assistance. | Other | APS Usual Care, CGA plus APS Usual Care |
Primary outcome
Self-Neglect Severity Scale (SSS)
Time frame: Baseline and 6-months
9 secondary outcomes
Functional Status
Time frame: Baseline and 6-months
Kohlman Evaluation of Living Skills (KELS)
Time frame: Baseline and 6-months
Mini-mental State Exam (MMSE)
Time frame: Baseline and 6-months
15-item Geriatric Depression Scale
Time frame: Baseline and 6-months
Physical Performance Test (PPT)
Time frame: Baseline and 6-months
SF-36 Health Survey
Time frame: Baseline and 6-months
The Duke Social Support Index (DSSI)
Time frame: Baseline and 6-months
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Baseline and 6-months
Costs of Social Services and Health Care Utilization and Costs
Time frame: Months 1,2,3,4,5,6
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 18 Jun 2013.
Related trials for Self-Neglect
Recruiting
Leveraging Adult Protective Service Interaction to Offer Evidence-Based Treatment for Depression in Elder Neglect/Self Neglect
Depression in Old Age
Recruiting
Improving Adult Protective Services Client Outcomes: A Stepped-Care Social and Mental Health Engagement Program
Depression in Old Age
Not yet recruiting
Replication and Evaluation of the RISE-APS Model In New Contexts
Elder Abuse, Self-Neglect
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.
Carmel B. Dyer, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Self-Neglect and Cognitive Ability, General, run by The University of Texas Health Science Center, Houston 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 5 inclusion and 6 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 18 Jun 2013. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Self-Neglect Severity Scale (SSS) (time frame: Baseline and 6-months). 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 18 Jun 2013.