Accidental FallsNCT00413933
Comprehensive Intervention for Falls Prevention in the Elderly
A study testing Comprehensive Multidisciplinary Intervention in people with Accidental Falls, run by Soroka University Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Comprehensive Multidisciplinary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Living in Beer Sheva or Ofakim , Israel
- Members of Clalit HMO
- 1 or more falls in past 12 month (self-reported)
- Age 65 or more
- Mobile outdoors without wheelchair
Who cannot join
- Seriously ill patients - as dyspnea with light exercise, unstable heart disease
- MMSE less than 18
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Family Medicine, Faculty of Health Sciences, Ben Gurion University of the Negev
Beersheba
About this study
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.
Read the detailed description
Falls and related injuries among elderly people are a major public health problem worldwide.All older people with recurrent falls or assessed as being at increased risk of falling should be considered for an individualized multifactorial intervention.
In successful multifactorial intervention programmes the following specific components are common - against a background of the general diagnosis and management of causes and recognized risk factors:
- exercise
- home hazard assessment and intervention
- vision assessment and referral
- medications list review with modification/withdrawal We will address to 4000 randomly chosen patients from study population (elderly (65+) men and women, living in Beer-Sheva and Ofakim , Israel and belonging to Clalit HMO). This telephone interview will be conducted to reveal falls in last 12 months. The people who do fall (1 + falls) will be invited to research assistant.
In that meeting the research assistant will explain about the study aims and ask them to sign informed consent. Those who do not agree to participate - will be referred to their family doctor for further assessment.
Those 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. All participants will be instructed to call to the research assistant closely to each fall.
All information about assessment of patients in both groups will be transferred to the family physician. Their family physician according to his opinion will treat patients from usual care group.
A geriatrician, physiotherapist and occupational therapist will observe patients in the intervention group. OT will conduct a home visit to assess hazard and level of risk factor for falling. Results of assessment will be discussed on multi- disciplinary team meeting.
According to this plan each patient in this group will receive one or more following interventions:
- Written recommendation to the family physician for medication adjustment. As well, the geriatrician will discuss with family physician these recommendations.
- Recommendation to the family physician to refer the patient to optometrist/ ophthalmologist.
- Physical therapy: each 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.
- Occupational therapy: OT will make recommendation for changing any unsafe environments in the home.
First follow-up (four months after baseline assessment):
- OT will make a second home visit to each subject of the intervention group to check recommendation fulfillment.
- Study assistant will repeat baseline assessment (MMSE, GDS, BI, TU\&G and visual assessment by Snellen chart).
- Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
- Information about medication adjustment and changes will be collected from Clalit computerized system.
Second follow-up (12 months after baseline assessment ) :
- Study assistant will repeat baseline assessment (MMSE, GDS, BI, TUG test and visual assessment by Snellen chart).
- Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
- Information about medication adjustment and changes will be collected from Clalit computerized system.
- Conditions
- Accidental Falls
- Being tested
- Comprehensive Multidisciplinary Intervention
- Keywords
- falls, prevention, elderly, multidisciplinary intervention, health care utilization
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Multidisciplinary InterventionProcedure or surgery
Comprehensive Multidisciplinary Intervention
| Study group | Role | What they receive |
|---|---|---|
| Intrevention group | Experimental | each 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 Receives: Procedure: Comprehensive Multidisciplinary Intervention |
| Control group | No intervention | Those 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of falls
Measured: 4 and 12 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2006 (estimated)
- Study startApr 2008
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: The study was stopped due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Press, Soroka University Medical Center
- Investigators
- Yan Press, MD, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413933
- Sponsor's protocol ID
- sor444506ctil
- Status last verified
- Dec 2006
- First submitted
- 19 Dec 2006
- Last updated
- 21 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Intervention for Falls Prevention in the Elderly
- ClinicalTrials.gov ID
- NCT00413933
- Acronym / sponsor ID
- sor444506ctil
- Conditions
- Accidental Falls
- Keywords
- falls, prevention, elderly, multidisciplinary intervention, health care utilization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to lack of funding
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Falls and related injuries among elderly people are a major public health problem worldwide.All older people with recurrent falls or assessed as being at increased risk of falling should be considered for an individualized multifactorial intervention.
In successful multifactorial intervention programmes the following specific components are common - against a background of the general diagnosis and management of causes and recognized risk factors:
- exercise
- home hazard assessment and intervention
- vision assessment and referral
- medications list review with modification/withdrawal We will address to 4000 randomly chosen patients from study population (elderly (65+) men and women, living in Beer-Sheva and Ofakim , Israel and belonging to Clalit HMO). This telephone interview will be conducted to reveal falls in last 12 months. The people who do fall (1 + falls) will be invited to research assistant.
In that meeting the research assistant will explain about the study aims and ask them to sign informed consent. Those who do not agree to participate - will be referred to their family doctor for further assessment.
Those 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. All participants will be instructed to call to the research assistant closely to each fall.
All information about assessment of patients in both groups will be transferred to the family physician. Their family physician according to his opinion will treat patients from usual care group.
A geriatrician, physiotherapist and occupational therapist will observe patients in the intervention group. OT will conduct a home visit to assess hazard and level of risk factor for falling. Results of assessment will be discussed on multi- disciplinary team meeting.
According to this plan each patient in this group will receive one or more following interventions:
- Written recommendation to the family physician for medication adjustment. As well, the geriatrician will discuss with family physician these recommendations.
- Recommendation to the family physician to refer the patient to optometrist/ ophthalmologist.
- Physical therapy: each 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.
- Occupational therapy: OT will make recommendation for changing any unsafe environments in the home.
First follow-up (four months after baseline assessment):
- OT will make a second home visit to each subject of the intervention group to check recommendation fulfillment.
- Study assistant will repeat baseline assessment (MMSE, GDS, BI, TU\&G and visual assessment by Snellen chart).
- Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
- Information about medication adjustment and changes will be collected from Clalit computerized system.
Second follow-up (12 months after baseline assessment ) :
- Study assistant will repeat baseline assessment (MMSE, GDS, BI, TUG test and visual assessment by Snellen chart).
- Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
- Information about medication adjustment and changes will be collected from Clalit computerized system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrevention group | Experimental | Procedure: Comprehensive Multidisciplinary Interventioneach 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 intervention | –Those 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Living in Beer Sheva or Ofakim , Israel
- Members of Clalit HMO
- 1 or more falls in past 12 month (self-reported)
- Age 65 or more
- Mobile outdoors without wheelchair
Key exclusion criteria (2 listed)
- Seriously ill patients - as dyspnea with light exercise, unstable heart disease
- MMSE less than 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Multidisciplinary InterventionComprehensive Multidisciplinary Intervention | Procedure or surgery | Intrevention group |
Primary outcome
number of falls
Time frame: 4 and 12 monthes
Results and safety
The study was stopped early (reason given: The study was stopped due to lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Press, MD principal investigator
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Multidisciplinary Intervention in people with Accidental Falls, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped due to lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of falls (time frame: 4 and 12 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.