NCT00249925

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
319

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

4.4 years

First QC Date

November 4, 2005

Last Update Submit

April 25, 2016

Conditions

Frail Elderly

Keywords

Home modificationOccupational TherapyPhysical TherapyHome care

Outcome Measures

Primary Outcomes (3)

  • Functional difficulty

  • Fear of falling

  • Self-efficacy

Secondary Outcomes (3)

  • Home hazards

  • Control oriented strategy use

  • Mortality

Interventions

Home-Based InterventionBEHAVIORAL
Multi-component home-based interventionBEHAVIORAL

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philadelphia Corporation for Aging (PCA)

Philadelphia, Pennsylvania, 19130, United States

Location

Related Publications (1)

  • 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.

    PMID: 20663239DERIVED

Study Officials

  • Laura N Gitlin, Ph.D

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2005

First Posted

November 7, 2005

Study Start

January 1, 2000

Primary Completion

June 1, 2004

Study Completion

January 1, 2005

Last Updated

April 26, 2016

Record last verified: 2016-04

Locations

US(1)