Project ABLE:Advancing Better Living for Elders | NCT00249925

Studies
Project ABLE:Advancing Better Living for Elders

NCT00249925

Sponsor

Thomas Jefferson University

Status

Completed

Last Update Posted

Apr 26, 2016Estimated

Enrollment

319

Phase

Phase 3

Conditions

Frail Elderly

Interventions

Home-Based Intervention
Multi-component home-based intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2000

Primary Completion Date

Jun 2004Actual

Completion Date

Jan 2005Actual

First Submitted Date

Nov 4, 2005

First Submission Date that Met QC Criteria

Nov 4, 2005

First Posted Date

Nov 7, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2016

Last Update Posted Date

Apr 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The specific aims of the study are to: 1) test the effectiveness of a home-bases intervention to improve home safety, fall efficacy and functional performance; 2) determine if the use of environmental strategies results in occurrence of less negative health events (falls and depression); 3) compare types of environmental strategies accepted and used under different treatment conditions; and 4) evaluate the cost-effectiveness of the intervention program.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

319

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional difficulty
Fear of falling
Self-efficacy

Secondary Outcomes

Measure	Description	Time Frame
Home hazards
Control oriented strategy use
Mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

70 years or older
community dwelling
functional vulnerability/HRCA vulnerability index= >1 problem area

Exclusion Criteria:

Mini-Mental Status Examination (MMSE) score of less than or equal to 23
legal blindness
bed bound
nursing home placement or relocation expected within 12 months of study eligibility

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laura N Gitlin, Ph.D	Thomas Jefferson University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Philadelphia Corporation for Aging (PCA)		Philadelphia	Pennsylvania	19130	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20663239	Derived	Rose KC, Gitlin LN, Dennis MP. Readiness to use compensatory strategies among older adults with functional difficulties. Int Psychogeriatr. 2010 Dec;22(8):1225-39. doi: 10.1017/S1041610210001584. Epub 2010 Jul 27.

Name	Type	Description	Arm Group Labels	Other Names
Home-Based Intervention	Behavioral
Multi-component home-based intervention	Behavioral