Project ABLE:Advancing Better Living for Elders

Frail Elderly Clinical Trial

Official title:

Enhancing Function of Frail Elders At Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249925
• Other study ID #: Ro1AG13687
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2005
• Last updated: April 25, 2016
• Start date: January 2000
• Est. completion date: January 2005

Study information

• Verified date: April 2016
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: January 2005
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Frail Elderly

Intervention

Behavioral:
• Home-Based Intervention

• Multi-component home-based intervention

Locations

Country	Name	City	State
United States	Philadelphia Corporation for Aging (PCA)	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional difficulty
Primary	Fear of falling
Primary	Self-efficacy
Secondary	Home hazards
Secondary	Control oriented strategy use
Secondary	Mortality