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Trial to Reduce Falls Incidence Rate in Frail Elderly (CP)

This study has been terminated.
(Extremely difficult recruitment. Preliminary analysis showed no effect of the intervention.)
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Stichting Nuts Ohra
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00512655
First received: August 7, 2007
Last updated: July 6, 2010
Last verified: June 2010
  Purpose

Background: Approximately 750,000 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 (N=160).

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 caregiver's 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.


Condition Intervention
Accidental Falls
Behavioral: Fall prevention course

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial to Reduce Falls Incidence Rate in Frail Elderly

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Falls incidence rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Burden for the caregiver [ Time Frame: 4 measurements within 6 months ] [ Designated as safety issue: No ]
  • Quality of life (MOS-20) [ Time Frame: 4 measurements within 6 months ] [ Designated as safety issue: No ]
  • Balance confidence [ Time Frame: 4 measurements within 6 months ] [ Designated as safety issue: No ]
  • Depression and general anxiety [ Time Frame: 4 measurements within 6 months ] [ Designated as safety issue: No ]
  • Functional performance and activities of daily living [ Time Frame: 4 measurements within 6 months ] [ Designated as safety issue: No ]
  • Mood [ Time Frame: 4 measurements within 6 months ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: 4 measurements within 6 months ] [ Designated as safety issue: No ]
  • Mobility [ Time Frame: 4 measurements within 6 months ] [ Designated as safety issue: No ]
  • Balance [ Time Frame: 4 measurements within 6 months ] [ Designated as safety issue: No ]
  • Cognition [ Time Frame: 4 measurements within 6 months ] [ Designated as safety issue: No ]
  • Fear of falling (FES) [ Time Frame: 4 measurements within 6 months ] [ Designated as safety issue: No ]
  • Mental well being [ Time Frame: 4 measurements within 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: January 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intervention: 5 week training program, 2 sessions per week (total of 10 sessions). Training includes both the patient and the caregiver. The training consists of two components: a cognitive and a physical component.
Behavioral: Fall prevention course
Duration: 5 weeks, 2 sessions of 2 hours per week: 10 sessions in total.
No Intervention: 2
Usual care.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least one fall in the last 6 months
  • Living in their own home or in a home for the aged
  • Availability of a primary caregiver caring for the patient at least once a week
  • Ability to walk 15 meters independently (use of a walking aid is permitted)
  • Life expectancy of more than 6 months, as judged by their geriatrician

Exclusion Criteria:

  • Dyads of patients and caregivers in whom outcome assessment is highly unlikely to succeed, for example because they proved not to be able to register falls in the three months before randomization, will be excluded
  • MMSE score of less than 15
  • On the waiting list for a nursing home
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512655

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Rijnstate Ziekenhuis
Arnhem, Netherlands
CWZ
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Stichting Nuts Ohra
Investigators
Principal Investigator: Prof. Dr. M. Olde Rikkert, MD PhD Radboud University
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. MGM Olde Rikkert, Radboud University Nijmegen Medical Center
ClinicalTrials.gov Identifier: NCT00512655     History of Changes
Other Study ID Numbers: CP MM 19-08-12-05-30-08, SNO-T-0601-60, ZonMw 920-03-457
Study First Received: August 7, 2007
Last Updated: July 6, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
Fear of falling
Intraindividual variability
Cognition
Fall prevention
Fear
Frail elderly
Intervention

ClinicalTrials.gov processed this record on November 20, 2014