Trial to Reduce Falls Incidence Rate in Frail Elderly

NCT00512655 | Terminated

• 3 other identifiers: CP MM 19-08-12-05-30-08SNO-T-0601-60ZonMw 920-03-457
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Accidental Falls

Keywords

Fear of falling; Intraindividual variability; Cognition; Fall prevention; Fear; Frail elderly; Intervention

Outcome Measures

Primary Outcomes (1)

• Falls incidence rate

  6 months

Secondary Outcomes (12)

• Burden for the caregiver

  4 measurements within 6 months

• Quality of life (MOS-20)

  4 measurements within 6 months

• Balance confidence

  4 measurements within 6 months

• Depression and general anxiety

  4 measurements within 6 months

• Functional performance and activities of daily living

  4 measurements within 6 months

Study Arms (2)

1

EXPERIMENTAL

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

2

NO INTERVENTION

Usual care.

Interventions

Fall prevention course BEHAVIORAL

Duration: 5 weeks, 2 sessions of 2 hours per week: 10 sessions in total.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Stichting Nuts Ohra: collaborator

Study Sites (3)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Rijnstate Ziekenhuis

Arnhem, Netherlands

Location

CWZ

Nijmegen, Netherlands

Location

Related Publications (1)

• Faes MC, Reelick MF, Melis RJ, Borm GF, Esselink RA, Rikkert MG. Multifactorial fall prevention for pairs of frail community-dwelling older fallers and their informal caregivers: a dead end for complex interventions in the frailest fallers. J Am Med Dir Assoc. 2011 Jul;12(6):451-8. doi: 10.1016/j.jamda.2010.11.006. Epub 2010 Dec 24.

  PMID: 21450224 DERIVED

Study Officials

• Prof. Dr. M. Olde Rikkert, MD PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 8, 2007
• Study Start: January 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 7, 2010

Record last verified: 2010-06

Locations

NL (3)