NCT07628816

Brief Summary

This study aims to examine fall behaviors, fear of falling, and self-efficacy levels in older adults living at home through a digital storytelling program based on Pender's Health Promotion Model, and to evaluate the effect of this program on these variables. Research hypotheses: H1.1: The Digital Storytelling Program based on Pender's Health Promotion Model reduces the number of falls among the elderly. H1.2: The Digital Storytelling Program based on Pender's Health Promotion Model reduces the risk of falls among the elderly. H1.3: The Digital Storytelling Program based on Pender's Health Promotion Model reduces the fear of falling among the elderly. H1.4: The Digital Storytelling Program based on Pender's Health Promotion Model affects the total score of the Falling Behaviors Scale for the Elderly (FBS) among the elderly. The general population of the study consisted of 80 individuals aged 65 and over registered at family health centers in Avanos district of Nevşehir province. The sample of the study was calculated as 80 people in the analysis performed using the "G. Power-3.1" program with 95% power, 0.05 margin of error and 0.82 effect size. The effect of safe movement and walking program on reducing fear of falling in elderly individuals living in nursing homes. In the study, 40 people were assigned to each group using stratified randomization method. Inclusion criteria: Literate, Living at home, 65 years and older, Having internet access, Able to use communication tools such as computers, tablets or smartphones, Able to communicate verbally and visually, Not having physical conditions or diseases that would prevent exercise (Stroke, Parkinson's, uncontrolled arrhythmia, serious heart disease-aortic stenosis, angina, severe musculoskeletal disease, knee and hip replacement in the last 6 months). (being bedridden), Agreeing to participate in the study. Exclusion criteria: Bedridden, Visually impaired, Moderate to severe cognitive impairment (Mini Mental State Test - MMD \<24).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress84%
Apr 2026Jun 2026

Study Start

First participant enrolled

April 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

May 22, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Older AdultsFear of FallingDigital Storytelling

Outcome Measures

Primary Outcomes (3)

  • Fear of Falling Scale

    The "Fear of Falling Scale" is used to assess a person's fear of falling while performing daily activities and developed by Tinetti et al. (1990). The scale, consisting of 10 items, has a Cronbach's alpha coefficient of 0.71 in the original study. The Turkish version, validated and proven reliable by Erdem and Emel (2004). The scale items inquire whether individuals experience fear of falling while performing activities such as "bathing, reaching into a cupboard to get an item, walking in the garden, answering the door or phone, sitting down and standing up from a chair, dressing and undressing, getting in and out of bed, doing chores in their room, and simple shopping." For each question, individuals receive "1 point for Yes" if they experience fear of falling and "0 points for No" if they do not. An increase in the average fear of falling score indicates an increased fear of falling while performing daily life activities.

    From enrollment to the end of treatment at 12 weeks.

  • Self-Efficacy/Competence Scale

    It was developed and revised by Sherer et al. (63) in 1982. Its reliability and validity in Turkish was established by Gözüm and Aksayan (9) in 1999. The Cronbach Alpha value is 0.81, and the test-retest reliability was found to be 0.92. The scale consists of 23 items and four sub-factors (behavior initiation, behavior completion, behavior maintenance, and overcoming obstacles). A minimum score of 23 and a maximum score of 115 are obtained from the scale. A high total score indicates a high perception of self-efficacy/competence. It is a 5-point Likert-type scale. It consists of options ranging from "Does not describe me at all" (1) to "Describes me very well" (5). However, items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 are scored in the opposite direction.

    From enrollment to the end of treatment at 12 weeks

  • Fall Behavior Scale for the Elderly

    Fall Behavior Scale for the Elderly: Developed by Clemson et al. (2003), this scale consists of 30 items and 10 sub-dimensions. Based on self-report, the scale aims to identify the behaviors and awareness that older adults exhibit to protect themselves from potential falls. The items in the scale inquire about activities related to home life, lighting and vision, shoe use, outdoor activities, and daily life. Each item is scored from 1 to 4 on a 4-point Likert scale. "Never" is worth 1 point, while the others are worth 2 points each for "occasionally," 3 points for "usually," and 4 points for "always." The lowest and highest possible scores for the total scale and its subscales range from 1 to 4. Higher scores indicate safe/protective behaviors related to falls, while lower scores indicate risky behaviors. The sub-dimensions of the scale are as follows: The scale consists of the following items: Cognitive Adaptation (6 items), Mobility (5 items), Avoidance (5 items), Awareness (4 items

    From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

'Digital Storytelling Program Based on Pender's Health Promotion Model on Fall Behaviors, Fear of Falling, and Self-Efficacy'

Behavioral: Digital Storytelling Program Based on Pender's Health Promotion Model on Fall Behaviors, Fear of Falling, and Self-Efficacy

Control group

NO INTERVENTION

Interventions

Pre-intervention: Elderly individuals meeting the inclusion and exclusion criteria will be administered an introductory information form, the Fear of Falls Scale, and the Fall Behaviors Scale for the Elderly. Intervention implementation: Elderly individuals in the experimental group will be shown digital stories prepared within the framework of Pender's Health Promotion Model-Based Digital Storytelling Program, focusing on Individual Characteristics and Experiences, Behavior-Specific Concepts and Effects, and Behavioral Outcomes. Post-intervention: Immediately after the six-week intervention and three months after its completion, the Fear of Falls Scale and the Fall Behaviors Scale for the Elderly will be collected through face-to-face interviews with individuals.

Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Participants must be literate,
  • Live at home,
  • years of age or older,
  • Have internet access,
  • Able to use communication tools such as computers, tablets or smartphones,
  • Able to communicate verbally and visually,
  • Not have any physical condition or illness that would prevent them from exercising (Stroke, Parkinson's, uncontrolled arrhythmia, serious heart disease - aortic stenosis, angina, severe musculoskeletal disease, having had knee or hip replacement surgery in the last 6 months),
  • Agree to participate in the study.

You may not qualify if:

  • Bedridden,
  • Visually impaired,
  • Moderate to severe cognitive impairment (Mini Mental State Test - MMD \<24)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırsehir Ahi Evran University

Kırşehir, Kırşehir, 40000, Turkey (Türkiye)

Location

Related Publications (1)

  • Petersen N, Konig HH, Hajek A. The link between falls, social isolation and loneliness: A systematic review. Arch Gerontol Geriatr. 2020 May-Jun;88:104020. doi: 10.1016/j.archger.2020.104020. Epub 2020 Jan 30.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

May 22, 2026

First Posted

June 5, 2026

Study Start

April 1, 2026

Primary Completion

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share
Shared Documents
ANALYTIC CODE

Locations