Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2010-08-31
2013-08-31
Brief Summary
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Detailed Description
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Interventions targeting fear of falling, typically delivered in groups and incorporating cognitive restructuring, education, and exercise, have been shown to increase fall-related self-efficacy. Avoidance is resistant to treatment, however, and more than one-third of patients enrolled in these interventions drop out. Factors associated with attrition include high levels of fear and avoidance, indicating that the individuals most in need of such programs are those most likely to withdraw prematurely. These data suggest that avoidance should be targeted in treatment, and that interventions should be designed to reach very fearful individuals who are most likely to drop out of traditional fear of falling programs.
Participation in this study will last up to 8 months. Participants will be randomly assigned to receive either the ABLE intervention or an education control condition. The control condition will consist of in-person education about falls to control for the time and attention provided in the ABLE arm.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Education about falls
In-person education about falls with a health educator.
Fall prevention education
In-home, individual sessions with a health educator regarding fall prevention
Activity, Balance, Learning, and Exposure
Intervention combining medication review, exercise, home safety evaluation, and exposure therapy.
Activity, Balance, Learning, and Exposure
An in-home intervention that integrates exposure therapy with cognitive restructuring, exercise, and a home safety evaluation.
Interventions
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Activity, Balance, Learning, and Exposure
An in-home intervention that integrates exposure therapy with cognitive restructuring, exercise, and a home safety evaluation.
Fall prevention education
In-home, individual sessions with a health educator regarding fall prevention
Eligibility Criteria
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Inclusion Criteria
2. Severe fear as measured by a brief FES-I score \> or = 13.
3. Low to moderate actual risk of falls as set out in Lamb et al. (2008).
4. Distress or functional impairment due to fear of falling.
5. Approval from the patient's primary health care provider.
Exclusion Criteria
2. Bedbound, wheelchair-dependent, paralyzed in the lower extremities, or requiring the assistance of another person to transfer, walk, or perform intervention exercises within the home.
3. Dementia or cognitive impairment as measured by a score above 10 on the Blessed Orientation Memory Test.
4. Corrected visual acuity \< 20/60.
5. Current participation in psychotherapy or professional rehabilitation services (PT, OT) or in the process of being referred or evaluated for such services. Patients who develop a need for such services during their participation will complete an assessment prior to commencing the outside therapy but will be allowed to continue in the study.
6. Active suicidal ideation
7. Lifetime diagnosis of bipolar I or II disorder or any psychotic disorder.
8. Alcohol or other substance abuse or dependence within six months.
9. Psychosocial factors that would compromise study participation (e.g. homelessness, no telephone).
10. History of osteoporotic fracture.
11. Experiencing 3 or more falls in the past year.
12. Body Mass Index of 17.0 or under.
13. Significant orthostasis, defined as a 20 point or greater difference between seated and standing blood pressure, either systolic or diastolic.
65 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of California, San Diego
OTHER
Responsible Party
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Julie Wetherell
Professor
Principal Investigators
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Julie Wetherell, PhD
Role: PRINCIPAL_INVESTIGATOR
UCSD
Locations
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University of California San Diego
San Diego, California, United States
Countries
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References
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