NCT00901706

Brief 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 elders with substantiated self-neglect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2009

Typical duration for early_phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

2.5 years

First QC Date

May 12, 2009

Last Update Submit

June 17, 2013

Conditions

Keywords

Self-NeglectComprehensive Geriatric Assessment (CGA)Geriatric SyndromesQuality of LifeBasic Activities of Daily LivingInstrumental Activities of Daily Living

Outcome Measures

Primary Outcomes (1)

  • Self-Neglect Severity Scale (SSS)

    Baseline and 6-months

Secondary Outcomes (9)

  • Functional Status

    Baseline and 6-months

  • Kohlman Evaluation of Living Skills (KELS)

    Baseline and 6-months

  • Mini-mental State Exam (MMSE)

    Baseline and 6-months

  • 15-item Geriatric Depression Scale

    Baseline and 6-months

  • Physical Performance Test (PPT)

    Baseline and 6-months

  • +4 more secondary outcomes

Study Arms (2)

CGA plus APS Usual Care

EXPERIMENTAL

Comprehensive geriatric assessment coupled with Adult Protective Services (APS) usual care for elders with self-neglect.

Other: Comprehensive Geriatric Assessment and APS Usual CareOther: APS usual care

APS Usual Care

ACTIVE COMPARATOR

APS usual care consisting of social, medical, and legal interventions.

Other: Comprehensive Geriatric Assessment and APS Usual CareOther: APS usual care

Interventions

Comprehensive Geriatric Assessment coupled with APS usual care which collectively will consist standardized cognitive, functional, affective, social, and legal interventions.

Also known as: Randomized Controlled Trial
APS Usual CareCGA plus APS Usual Care

APS usual care consists of social, medical, and legal assistance.

Also known as: Randomized Controlled Trial
APS Usual CareCGA plus APS Usual Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age or older
  • English Speaking
  • Resident of Harris County, Houston Texas
  • Community-dwelling
  • Substantiated Self-Neglect

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Geriatric AssessmentRandomized Controlled Trials as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthControlled Clinical Trials as TopicClinical Trials as TopicClinical Studies as TopicEpidemiologic Study Characteristics

Study Officials

  • Carmel B. Dyer, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Internal Medicine, Geriatrics

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 14, 2009

Study Start

August 1, 2009

Primary Completion

February 1, 2012

Study Completion

July 1, 2012

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations