NCT04139109

Brief Summary

The Survey of Activities and Fear of Falling in the Elderly (SAFE) was originally developed in English to determine the level of fear of falling and its interactions with activities of daily living. The purpose of this study was to translate and cross-culturally adapt the SAFE instrument into Turkish and investigate its psychometric properties.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

October 22, 2019

Last Update Submit

October 5, 2024

Conditions

Keywords

accidental fallsactivity restrictionfear of fallingparticipation restrictionpsychometrics

Outcome Measures

Primary Outcomes (1)

  • The Survey of Activities and Fear of Falling in the Elderly

    The Survey of Activities and Fear of Falling in the Elderly (SAFE), is a reliable (α = 0.95) and valid (r = 0.91) questionnaire for evaluating activity level, fear of falling, and activity restriction. SAFE assesses 11 community-based and home-based activities. SAFE is scored as the following: Activity level is scored as the number of activities being done. Maximum score is 11 and higher scores indicate a higher activity level. The fear of falling score is computed as the average worry scores across the 11 activities (or across as many of the activities that are done, i.e., if yes to A). Each activity is scored in the range 0 to 3 by recoding the answer. The recoding is described as 0=4 (Not at all worried), 1=3 (A little worried), 2=1 (Somewhat worried) and 3=1 (Very worried). In totally, higher scores indicate a greater fear of falling. Activity restriction is scored by counting the number of activities which is responded "less than you used to".

    Baseline (First assessment)

Secondary Outcomes (4)

  • The Survey of Activities and Fear of Falling in the Elderly

    Within a 5-to-7-day period after the first assessment (Second assessment)

  • Falls Efficiency Scale-International

    Baseline (First assessment)

  • History of Fall

    Baseline (First assessment)

  • Leg Pain

    Baseline (First assessment)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

One-hundred eleven older adults who were admitted to the Department of Geriatrics at Istanbul Medeniyet University Goztepe Training and Research Hospital or who volunteered to participate in this study via an online form, were evaluated between January 2018 and July 2018.

You may qualify if:

  • age over 60 years old
  • ability to read and write in Turkish
  • score ≥24 on the Mini-Mental State Exam
  • \>3 according to the Functional Ambulation Category (FAC)
  • no pathology in visual ability and hearing

You may not qualify if:

  • neurologist-diagnosed dementia or Alzheimer's disease
  • ambulatory only with a wheelchair
  • amputated lower extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

Location

Related Publications (5)

  • Lachman ME, Howland J, Tennstedt S, Jette A, Assmann S, Peterson EW. Fear of falling and activity restriction: the survey of activities and fear of falling in the elderly (SAFE). J Gerontol B Psychol Sci Soc Sci. 1998 Jan;53(1):P43-50. doi: 10.1093/geronb/53b.1.p43.

    PMID: 9469171BACKGROUND
  • Allison LK, Painter JA, Emory A, Whitehurst P, Raby A. Participation restriction, not fear of falling, predicts actual balance and mobility abilities in rural community-dwelling older adults. J Geriatr Phys Ther. 2013 Jan-Mar;36(1):13-23. doi: 10.1519/JPT.0b013e3182493d20.

    PMID: 22790588BACKGROUND
  • Yardley L, Smith H. A prospective study of the relationship between feared consequences of falling and avoidance of activity in community-living older people. Gerontologist. 2002 Feb;42(1):17-23. doi: 10.1093/geront/42.1.17.

    PMID: 11815695BACKGROUND
  • Gazibara T, Kurtagic I, Kisic-Tepavcevic D, Nurkovic S, Kovacevic N, Gazibara T, Pekmezovic T. Falls, risk factors and fear of falling among persons older than 65 years of age. Psychogeriatrics. 2017 Jul;17(4):215-223. doi: 10.1111/psyg.12217. Epub 2017 Jan 27.

    PMID: 28130862BACKGROUND
  • Ersoz Huseyinsinoglu B, Tufekcioglu Z, Birinci T, Demirdag F. The Reliability and Validity of the Turkish Version of the Survey of Activities and Fear of Falling in the Elderly. J Geriatr Phys Ther. 2021 Apr-Jun 01;44(2):E132-E137. doi: 10.1519/JPT.0000000000000260.

MeSH Terms

Conditions

FrailtyMotor ActivityPatient Participation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Burcu Ersoz Huseyinsinoglu, PhD

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc Research Assistant

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 25, 2019

Study Start

January 22, 2018

Primary Completion

April 22, 2018

Study Completion

July 22, 2018

Last Updated

October 8, 2024

Record last verified: 2019-10

Locations