Study Stopped
The study was stopped due to lack of funding
Comprehensive Intervention for Falls Prevention in the Elderly
1 other identifier
interventional
8
1 country
1
Brief Summary
The purpose of this study is to determine whether the comprehensive multidisciplinary intervention (geriatrician, physical therapist and occupational therapist falls risk assessment and intervention)is effective in the falls prevention in the community dwelling elderly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2008
Longer than P75 for not_applicable
1 active site
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
December 19, 2006
CompletedFirst Posted
Study publicly available on registry
December 20, 2006
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedApril 21, 2016
December 1, 2006
3.2 years
December 19, 2006
April 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of falls
4 and 12 monthes
Study Arms (2)
Intrevention group
EXPERIMENTALeach subject in intervention group will get 15 weekly sessions (each session - 45 minutes) of specified exercise from a physical therapist that specializes in fall prevention and walking device recommendations. All subjects will get brochure for home exercise. It will be expected for intervention group to exercise twice daily, each time for 20 minutes in addition to the PT sessions
Control group
NO INTERVENTIONThose who agree to participate in the study will fill in questionnaire about falls (causes, circumstance, results). All will pass through: cognitive assessment by the Mini-Mental State Examination (MMSE), affective assessment by the 15-item Geriatric Depression Scale (GDS), functional assessment by Barthel Index (BI), visual assessment by Snellen charts and basic gait assessment by a "Timed get Up and Go" test (TU\&G). Participants that fulfill inclusion criteria will be randomly assigned to the intervention group or the control group
Interventions
Comprehensive Multidisciplinary Intervention
Eligibility Criteria
You may qualify if:
- Living in Beer Sheva or Ofakim , Israel
- Members of Clalit HMO
- or more falls in past 12 month (self-reported)
- Age 65 or more
- Mobile outdoors without wheelchair
You may not qualify if:
- Seriously ill patients - as dyspnea with light exercise, unstable heart disease
- MMSE less than 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Family Medicine, Faculty of Health Sciences, Ben Gurion University of the Negev
Beersheba, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Press, MD
Ben-Gurion University of the Negev
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head of Unit for Community Geriatrics
Study Record Dates
First Submitted
December 19, 2006
First Posted
December 20, 2006
Study Start
April 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
April 21, 2016
Record last verified: 2006-12