Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512655
Status:
TERMINATED
Last Update Posted:
2010-07-07
First Post:
2007-08-07
Brief Title:
Trial to Reduce Falls Incidence Rate in Frail Elderly
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Randomized Controlled Trial to Reduce Falls Incidence Rate in Frail Elderly
Status:
TERMINATED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Extremely difficult recruitment Preliminary analysis showed no effect of the intervention
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CP
Brief Summary:
Background Approximately 750000 elderly Dutch people fall at least once a year which often results in physical injuries and a fear of falling with high costs and far-reaching consequences on functionality physical activity quality of life and mental well-being Falling is not only a burden for patients it is also a burden for their caregivers Recurrent falling is a complex problem However the pathophysiological background of falls gait problems and dementia is largely unknown The general pathophysiological hallmark of aging is a liability in homeostatic mechanisms of organs This liability results in an impaired ability to adapt to stress and in increased biological variation in outcome measures within individuals In this study the investigators aim at developing an intervention to reduce recurrent falling in frail elderly fallers
Hypotheses The investigators hypothesize that the intervention program will decrease the number of falls and fear of falling and increase mental well-being physical activity and functional performance in frail elderly people with a history of recurrent falling In addition the burden on the caregivers will be reduced due to the intervention and will be cost-effective Furthermore the investigators hypothesize that patients with a high short-term intra-individual biological variability in gait and cognition variables have a higher risk of falling worse gait performance and cognitive decline after long term follow-up
Study Design Randomized controlled single-blind trial
Study Population 160 patients referred to a geriatric outpatient clinic who fell at least once in the last 6 months and their primary caregivers N160
Intervention A multifaceted fall prevention program for frail elders to reduce falls incidence rate consisting of physical and cognitive components Moreover it includes a training program for caregivers in which they learn to support and give advice to the patients aiming to decrease the burden on the caregivers
Primary Outcome Measures The fall incidence rate is the primary outcome measure Total observation time of falls will be 6 months after the start of the intervention
Secondary Outcome Measures In the patients the secondary outcome measures are fear of falling FES quality of life MOS-20 depression and general anxiety functional performance in activities of daily living physical activity mobility gait parameters body sway and biomarkers of endothelial function and frailty For the caregiver the secondary outcome measures are caregivers burden mood and quality of life In addition intraindividual variability of cognition balance and gait in both patients and caregivers will be assessed and cost-effectiveness of the intervention will also be determined
Hypotheses The investigators hypothesize that the intervention program will decrease the number of falls and fear of falling and increase mental well-being physical activity and functional performance in frail elderly people with a history of recurrent falling In addition the burden on the caregivers will be reduced due to the intervention and will be cost-effective Furthermore the investigators hypothesize that patients with a high short-term intra-individual biological variability in gait and cognition variables have a higher risk of falling worse gait performance and cognitive decline after long term follow-up
Study Design Randomized controlled single-blind trial
Study Population 160 patients referred to a geriatric outpatient clinic who fell at least once in the last 6 months and their primary caregivers N160
Intervention A multifaceted fall prevention program for frail elders to reduce falls incidence rate consisting of physical and cognitive components Moreover it includes a training program for caregivers in which they learn to support and give advice to the patients aiming to decrease the burden on the caregivers
Primary Outcome Measures The fall incidence rate is the primary outcome measure Total observation time of falls will be 6 months after the start of the intervention
Secondary Outcome Measures In the patients the secondary outcome measures are fear of falling FES quality of life MOS-20 depression and general anxiety functional performance in activities of daily living physical activity mobility gait parameters body sway and biomarkers of endothelial function and frailty For the caregiver the secondary outcome measures are caregivers burden mood and quality of life In addition intraindividual variability of cognition balance and gait in both patients and caregivers will be assessed and cost-effectiveness of the intervention will also be determined
Detailed Description:
Nature and Extent of the Burden and Risks Associated with Participation Benefit and Group Relatedness The outcome of this study may have important reflections on protocols to prevent falling among elders and on health care decision makers to stimulate starting new fall clinics and implement these protocols Through this study the well-being and functionality of frail elders and their caregivers could be improved As falling has an enormous economic burden a new effective fall prevention intervention could reduce health care costs substantially The tests consisting of questionnaires and gait and balance measurement are non-invasive and safe Taking blood samples is an invasive procedure although no serious adverse effects are expected There are no foreseeable risks associated with participation in this study However a burden will be placed on participating individuals because the training sessions and measurements are time-consuming
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ZonMw 920-03-457 | None | None | None |
| SNO-T-0601-60 | None | None | None |