- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01609322
Exposure Therapy for Fear of Falling in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Approximately 7-14% of older adults living independently in the community, including more than 5% of those who have never experienced a fall, experience moderate to severe fear of falling. Fear of falling leads to decreased physical activity, disability, loss of independence, depression, anxiety, reduced social engagement, and poor quality of life. It is also a major independent risk factor for falls.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92103
- University of California San Diego
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 65 years old or older.
- Severe fear as measured by a brief FES-I score > or = 13.
- Low to moderate actual risk of falls as set out in Lamb et al. (2008).
- Distress or functional impairment due to fear of falling.
- Approval from the patient's primary health care provider.
Exclusion Criteria:
- Medical condition that would interfere with the safe conduct of the intervention or compromise study participation.
- 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.
- Dementia or cognitive impairment as measured by a score above 10 on the Blessed Orientation Memory Test.
- Corrected visual acuity < 20/60.
- 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.
- Active suicidal ideation
- Lifetime diagnosis of bipolar I or II disorder or any psychotic disorder.
- Alcohol or other substance abuse or dependence within six months.
- Psychosocial factors that would compromise study participation (e.g. homelessness, no telephone).
- History of osteoporotic fracture.
- Experiencing 3 or more falls in the past year.
- Body Mass Index of 17.0 or under.
- Significant orthostasis, defined as a 20 point or greater difference between seated and standing blood pressure, either systolic or diastolic.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Education about falls
In-person education about falls with a health educator.
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In-home, individual sessions with a health educator regarding fall prevention
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EXPERIMENTAL: Activity, Balance, Learning, and Exposure
Intervention combining medication review, exercise, home safety evaluation, and exposure therapy.
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An in-home intervention that integrates exposure therapy with cognitive restructuring, exercise, and a home safety evaluation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fear of falling
Time Frame: 2 months (primary)
|
Fear of Falling will be measured using the Falls Efficacy Scale - International (FES-I), a version of the most widely used measure of falls self-efficacy.
Assessments are performed at baseline, 1 month, 2 months (end of intervention - primary outcome point).
We will also collect data at 5 months (3 month follow-up) and 8 months (6 month follow-up).
|
2 months (primary)
|
Activity avoidance
Time Frame: 2 months (primary)
|
Activity avoidance will be assessed using a modified version of the Activity Card Sort, a set of photographs of older adults engaged in various activities that is used in rehabilitation settings.
Assessments are performed at baseline, 1 month, 2 months (end of intervention - primary outcome point), 5 months (3 month follow-up), and 8 months (6 month follow-up).
|
2 months (primary)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity - self-report
Time Frame: 2 months (primary)
|
Self-reported physical activity will be assessed with the Physical Activities Scale for the Elderly (PASE).
|
2 months (primary)
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Physical activity
Time Frame: 2 months
|
Accelerometers will also be used to measure physical activity.
Patients in the study will wear an Actigraph battery-operated activity monitor worn around the waist to measure physical activity continuously during waking hours.
Assessment will occur before and after the intervention.
|
2 months
|
Physical Performance
Time Frame: 2 months (primary)
|
Physical performance will be measured using the Short Physical Performance Battery (SPPB), which includes measured of balance, walking, and lower body strength.
|
2 months (primary)
|
Quality of Life
Time Frame: 2 months (primary)
|
Quality of life will be measured with the Quality of Life Inventory (QOLI).
|
2 months (primary)
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Depressive and Anxiety symptoms
Time Frame: 2 months (primary)
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Depressive and anxiety symptoms will be assessed with the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report measure with subscales assessing depressive and anxiety symptoms that does not include somatic items such as fatigue that can be associated with aging or medical conditions rather than psychiatric disorders.
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2 months (primary)
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Agoraphobic Avoidance
Time Frame: 2 months (primary)
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Agoraphobic avoidance will be measured using the 5-item agoraphobia subscale of the Fear Questionaire (FQ).
|
2 months (primary)
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Post Traumatic Stress Disorder Symptoms
Time Frame: 2 months (primary)
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Post Traumatic Stress Disorder (PTSD) symptoms will be measured with the 6-item abbreviated form of the PTSD Checklist (PCL).
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2 months (primary)
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Fear of Falling
Time Frame: 2 months (primary)
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Fear of falling will be measured using the Falling Questionaire, a 15-item survey assessing attitudes towards falling.
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2 months (primary)
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Avoidance
Time Frame: 2 months (primary)
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Avoidance of activities will be measured using the Fear of Falling Avoidance-Behavior Questionaire (FFABQ), a 14-item measure to assess avoidance behaviors.
|
2 months (primary)
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Falls
Time Frame: 2 months (primary)
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Recorded on fall diaries provided to investigators throughout the 2-month intervention and 6-month follow-up period.
|
2 months (primary)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Julie Wetherell, PhD, UCSD
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R34MH086668 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fear of Falling
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National Healthcare Group PolyclinicsActive, not recruitingFear of FallingSingapore
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Universidad de CaldasUniversidad de ManizalesUnknown
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Geriatric Education and Research InstituteMonash University; Khoo Teck Puat Hospital; Tan Tock Seng Hospital; Duke-NUS Graduate... and other collaboratorsCompletedFear of Falling | Physical PerformanceSingapore
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Gerencia de Atención Primaria, MadridActive, not recruitingFear of Falling | Falls | NursingSpain
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University Hospital, GenevaCompletedRehabilitation | Fear of Falling | Older AdultsSwitzerland
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UKK InstitutePirkanmaa Hospital District; Ministry of Education and Culture, FinlandTerminatedFear of Falling | Falls | Physical PerformanceFinland
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Istanbul University - Cerrahpasa (IUC)Not yet recruiting
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Atılım UniversityCompletedFear of Falling | Fear of MovementTurkey
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University of Central FloridaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingFall | Fear of Falling | Sedentary Behavior | Physical InactivityUnited States
-
Talita Cumi Ltd.Aetrex Worldwide IncCompleted
Clinical Trials on Fall prevention education
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The Cleveland ClinicRecruiting
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New York UniversityCompleted
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New York UniversityCompletedHealthy Aging | Accidental Fall | Injury PreventionUnited States
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University of Colorado, DenverNational Institute on Aging (NIA); Apple Inc.Active, not recruiting
-
Fooyin UniversityUnknown
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Ministry of Health, KuwaitRecruitingOsteo Arthritis Knee | Fall | Total Knee ReplacementKuwait
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Helse Møre og Romsdal HFNorwegian University of Science and Technology; Sykehuset Innlandet HFCompletedAccidental Falls | Hospitalized PatientsNorway
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Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Stichting...Terminated
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Massachusetts General HospitalCrico; Inspiren Inc; RGI Informatics LLCNot yet recruitingFalls and Falls With Injury
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Gérond'ifCompleted