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FallNCT04139109

The Turkish Version of the Survey of Activities and Fear of Falling in the Elderly

An observational study of Fall and Old Age; Debility, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Fall, Old Age; Debility, Fear
How many people
111 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Jan 2018to 22 Jul 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul University-Cerrahpasa

    Istanbul, Bakırkoy, 34147

Other trials in Turkey (Türkiye)

About this study

Official title: The Reliability and Validity of the Turkish Version of the Survey of Activities and Fear of Falling in the Elderly

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.

Read the detailed description

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. One hundred eleven older adults (72 females) with a mean age of 69 years (SD=7.22; range=60-87) were included. For cross-cultural adaptation, two bi-lingual translators used the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants completed the Turkish version of SAFE (SAFE-T) to evaluate test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The correlation with the Turkish version of the Falls Efficiency Scale-International (FES-T) was determined to check the validity.

Keywords
accidental falls, activity restriction, fear of falling, participation restriction, psychometrics
Medical subject headings
Frailty, Motor Activity, Patient Participation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: Baseline (First assessment)

Secondary outcomes (4)

  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".

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

  2. Falls Efficiency Scale-International

    Falls Efficiency Scale-International (FES-I) is a 16-item self-administered questionnaire that was designed to assess fear of falling in community-dwelling older people. It provides information on the level of concern about falls during daily living activities. Each item is rated on a four-point scale, where 1=not at all concerned, 2=somewhat concerned, 3=fairly concerned, and 4=very concerned. The total score ranges from 16 (no concern about falling) to 64 (extreme concern about falling). The Turkish version of FES-I (FES-T), which was previously reported as a reliable (α = 0.94) and valid (r = - 0.83) instrument, was used in the present study.

    Measured: Baseline (First assessment)

  3. History of Fall

    Frequency of falls in the last six months was questioned.

    Measured: Baseline (First assessment)

  4. Leg Pain

    Presence of leg pain at rest and during activity was questioned.

    Measured: Baseline (First assessment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2019
  2. Study start22 Jan 2018
  3. Primary completion22 Apr 2018
  4. Study completion22 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04139109
Sponsor's protocol ID
287826
Status last verified
Oct 2019
First submitted
22 Oct 2019
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 9469171

  • 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.

    PubMed 22790588

  • 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.

    PubMed 11815695

  • 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.

    PubMed 28130862

  • 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.

    PubMed 32049753

Questions about this trial

What is this clinical trial studying?

An observational study of Fall and Old Age; Debility, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Survey of Activities and Fear of Falling in the Elderly (time frame: Baseline (First assessment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04139109, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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