InjuriesPhase 1NCT00463658
Interdisciplinary Falls Prevention for Seniors
A Phase 1 study testing Falls Prevention in people with Injuries, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
With an aging population, an associated increase in the number of falls and fall injuries, there is a need to examine how health care services, such as home care, can best prevent falls among older people. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Injuries
- What is being tested?
- Falls Prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Aug 2007
- Phase
- Phase 1
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Must be English speaking
- 75 years of age and over
- Newly referred to and eligible for personal support services
- Living at home in the community
- Identified as being at risk for falls
Who cannot join
- Refusal to give informed consent
- Unable to read/write English and a translator is not available
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster University - Faculty of Health Sciences at Frid
Hamilton, Ontario, L8P 4M3
About this study
Official title: The Comparative Effects and Expenses of a Proactive Nurse-Led, Multifactorial and Interdisciplinary Team Approach to Falls Prevention for Older At-Risk Home Care Clients
With an aging population, an associated increase in the number of falls and fall injuries, there is a need to examine how health care services, such as home care, can best prevent falls among older people. This project will directly address this area by evaluating the effects and expense of an innovative approach to home care service delivery for older people at-risk for falls.
Read the detailed description
Falls and fall injuries are common-potentially preventable-causes of mortality, morbidity, functional decline, and increased health-care use and cost among community-living seniors over 75 years of age.
The knowledge gained from this project will directly address the Canadian Patient Safety Institute's priority areas for research in the Applied Health Services Research Stream by evaluating an innovative approach to reducing adverse events in a community-based (home care) setting.
The project will also identify the prevalence, determinants and costs of falls and fall injuries among older people requiring home care services. The design will be a two-armed; single blind randomized controlled trial of 110 older people 75 years and over, at risk for falls receiving hom care in Ontario. Subjects will be randomly allocated to either usual home care (control) or the interdisciplinary team. In the interdisciplinary group, a team of professional home care service providers, with specialized training in falls prevention, will proactively provide a comprehensive, coordinated and evidence based approach to falls prevention. The results will inform policies and practice related to the allocation and delivery of home care services for falls prevention across Canada.
- Conditions
- Injuries
- Being tested
- Falls Prevention
- Keywords
- Falls, Home Care, Aging Population, Clinical Effectiveness, Health Economics
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Falls PreventionOther
Also called Interdisciplinary Falls Prevention Team
Subjects in the interdisciplinary group will receive home care services from a team of professional service providers (CCAC Case Manager, Public Health Nurse (Registered Nurse), Occupational Therapist, Physiotherapist, Nutritionist) with experience and training in falls prevention. The team will provide a comprehensive, coordinated and evidence based approach to falls prevention through weekly case conferencing, a written interdisciplinary care plan, and joint client visits.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects in the interdisciplinary group received home care services from a team of professional service providers (CCAC Case Manager, Registered Nurse, Occupational Therapist, Physiotherapist, Registered Dietician) with experience and training in falls prevention. The team provided a comprehensive, coordinated and evidence based approach to falls prevention through regular home visits, weekly case conferencing, a single accessible fall prevention plan,and joint client visits. Receives: Other: Falls Prevention |
| 2 | No intervention | Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessing client's eligibility for in-home health services, arrangement and coordination of professional (i.e. nursing, occupational therapy, physiotherapy, social work, speech-language pathology, nutrition) and non-professional HSS, information and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessments with clients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of self-reported falls: Falls surveillance report
Measured: 10 minutes
Secondary outcomes (8)
Health-Related Quality of Life and Function: SF-36 Health Survey
Measured: 15-20 minutes
Gait and Balance: Performance-Oriented Mobility Assessment
Measured: 10 minutes
Depression: Centre for Epidemiological Studies in Depression Scale
Measured: 5-10 minutes
Standardized Mini Mental State Examination
Measured: 20-25 minutes
Confidence in Performing Activities of Daily Living: Modified Falls Efficacy Scale
Measured: 5-10 minutes
Nutritional risk: Screen II Questionnaire
Measured: 10-15 minutes
Cost of Use of Health Services: Health and Social Services Utilization Questionnaire
Measured: 20 minutes
Caregiver burden: Caregiver Strain Index
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startMay 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InjuriesStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Patient Safety Institute, Mississauga Halton Community Care Access Centre, Hamilton Niagara Haldimand Brant Community Care Access Centre, Ontario Ministry of Health and Long Term Care, Halton Region Health Department, Community Rehab
- Investigators
- Maureen Markle-Reid, RN MScN PhD, Principal investigator, School of Nursing, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463658
- Sponsor's protocol ID
- RFAAA0506164
- Status last verified
- May 2008
- First submitted
- 18 Apr 2007
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Isaranuwatchai W, Perdrizet J, Markle-Reid M, Hoch JS. Cost-effectiveness analysis of a multifactorial fall prevention intervention in older home care clients at risk for falling. BMC Geriatr. 2017 Sep 1;17(1):199. doi: 10.1186/s12877-017-0599-9.
PubMed 28863774Markle-Reid M, Browne G, Gafni A, Roberts J, Weir R, Thabane L, Miles M, Vaitonis V, Hecimovich C, Baxter P, Henderson S. The effects and costs of a multifactorial and interdisciplinary team approach to falls prevention for older home care clients 'at risk' for falling: a randomized controlled trial. Can J Aging. 2010 Mar;29(1):139-61. doi: 10.1017/S0714980809990377.
PubMed 20202271Markle-Reid M, Browne G, Gafni A, Roberts J, Weir R, Thabane L, Miles M, Vaitonis V, Hecimovich C, Baxter P, Henderson S. A cross-sectional study of the prevalence, correlates, and costs of falls in older home care clients 'at risk' for falling. Can J Aging. 2010 Mar;29(1):119-37. doi: 10.1017/S0714980809990365.
PubMed 20202270
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Effects and Expenses of a Proactive Nurse-Led, Multifactorial and Interdisciplinary Team Approach to Falls Prevention for Older At-Risk Home Care Clients
- ClinicalTrials.gov ID
- NCT00463658
- Acronym / sponsor ID
- RFAAA0506164
- Conditions
- Injuries
- Keywords
- Falls, Home Care, Aging Population, Clinical Effectiveness, Health Economics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Canadian Patient Safety Institute, Mississauga Halton Community Care Access Centre, Hamilton Niagara Haldimand Brant Community Care Access Centre, Ontario Ministry of Health and Long Term Care, Halton Region Health Department, Community Rehab
- Study start
- May 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 20 Apr 2007 (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.
With an aging population, an associated increase in the number of falls and fall injuries, there is a need to examine how health care services, such as home care, can best prevent falls among older people. This project will directly address this area by evaluating the effects and expense of an innovative approach to home care service delivery for older people at-risk for falls.
Detailed description
Falls and fall injuries are common-potentially preventable-causes of mortality, morbidity, functional decline, and increased health-care use and cost among community-living seniors over 75 years of age.
The knowledge gained from this project will directly address the Canadian Patient Safety Institute's priority areas for research in the Applied Health Services Research Stream by evaluating an innovative approach to reducing adverse events in a community-based (home care) setting.
The project will also identify the prevalence, determinants and costs of falls and fall injuries among older people requiring home care services. The design will be a two-armed; single blind randomized controlled trial of 110 older people 75 years and over, at risk for falls receiving hom care in Ontario. Subjects will be randomly allocated to either usual home care (control) or the interdisciplinary team. In the interdisciplinary group, a team of professional home care service providers, with specialized training in falls prevention, will proactively provide a comprehensive, coordinated and evidence based approach to falls prevention. The results will inform policies and practice related to the allocation and delivery of home care services for falls prevention across Canada.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Falls PreventionSubjects in the interdisciplinary group received home care services from a team of professional service providers (CCAC Case Manager, Registered Nurse, Occupational Therapist, Physiotherapist, Registered Dietician) with experience and training in falls prevention. The team provided a comprehensive, coordinated and evidence based approach to falls prevention through regular home visits, weekly case conferencing, a single accessible fall prevention plan,and joint client visits. |
| 2 | No intervention | –Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessing client's eligibility for in-home health services, arrangement and coordination of professional (i.e. nursing, occupational therapy, physiotherapy, social work, speech-language pathology, nutrition) and non-professional HSS, information and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessments with clients. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Must be English speaking
- 75 years of age and over
- Newly referred to and eligible for personal support services
- Living at home in the community
- Identified as being at risk for falls
Key exclusion criteria (2 listed)
- Refusal to give informed consent
- Unable to read/write English and a translator is not available
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 |
|---|---|---|
| Falls PreventionAlso: Interdisciplinary Falls Prevention TeamSubjects in the interdisciplinary group will receive home care services from a team of professional service providers (CCAC Case Manager, Public Health Nurse (Registered Nurse), Occupational Therapist, Physiotherapist, Nutritionist) with experience and training in falls prevention. The team will provide a comprehensive, coordinated and evidence based approach to falls prevention through weekly case conferencing, a written interdisciplinary care plan, and joint client visits. | Other | 1 |
Primary outcome
Number of self-reported falls: Falls surveillance report
Time frame: 10 minutes
8 secondary outcomes
Health-Related Quality of Life and Function: SF-36 Health Survey
Time frame: 15-20 minutes
Gait and Balance: Performance-Oriented Mobility Assessment
Time frame: 10 minutes
Depression: Centre for Epidemiological Studies in Depression Scale
Time frame: 5-10 minutes
Standardized Mini Mental State Examination
Time frame: 20-25 minutes
Confidence in Performing Activities of Daily Living: Modified Falls Efficacy Scale
Time frame: 5-10 minutes
Nutritional risk: Screen II Questionnaire
Time frame: 10-15 minutes
Cost of Use of Health Services: Health and Social Services Utilization Questionnaire
Time frame: 20 minutes
Caregiver burden: Caregiver Strain Index
Time frame: 5-10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
- Derived from this study: PubMed 28863774Isaranuwatchai W, Perdrizet J, Markle-Reid M, Hoch JS. Cost-effectiveness analysis of a multifactorial fall prevention intervention in older home care clients at risk for falling. BMC Geriatr. 2017 Sep 1;17(1):199. doi: 10.1186/s12877-017-0599-9.
- Derived from this study: PubMed 20202271Markle-Reid M, Browne G, Gafni A, Roberts J, Weir R, Thabane L, Miles M, Vaitonis V, Hecimovich C, Baxter P, Henderson S. The effects and costs of a multifactorial and interdisciplinary team approach to falls prevention for older home care clients 'at risk' for falling: a randomized controlled trial. Can J Aging. 2010 Mar;29(1):139-61. doi: 10.1017/S0714980809990377.
- Derived from this study: PubMed 20202270Markle-Reid M, Browne G, Gafni A, Roberts J, Weir R, Thabane L, Miles M, Vaitonis V, Hecimovich C, Baxter P, Henderson S. A cross-sectional study of the prevalence, correlates, and costs of falls in older home care clients 'at risk' for falling. Can J Aging. 2010 Mar;29(1):119-37. doi: 10.1017/S0714980809990365.
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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.
Maureen Markle-Reid, RN MScN PhD principal investigator
School of Nursing, McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Falls Prevention in people with Injuries, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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: finished, as of the sponsor's last update on 7 May 2008. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 self-reported falls: Falls surveillance report (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00463658, which also lists 3 linked publications.
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 7 May 2008.