- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07628816
The Effect of a Digital Storytelling Program on Fall Among Community-Dwelling Older Adults
The Effect of a Digital Storytelling Program Based on Pender's Health Promotion Model on Fall Behaviors, Fear of Falling, and Self-Efficacy Among Community-Dwelling Older Adults
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).
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kırşehir
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Kırşehir, Kırşehir, Turkey (Türkiye), 40000
- Kırşehir Ahi Evran University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must be literate,
- Live at home,
- 65 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.
Exclusion Criteria:
- Bedridden,
- Visually impaired,
- Moderate to severe cognitive impairment (Mini Mental State Test - MMD <24)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
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Active Comparator: Intervention Group
'Digital Storytelling Program Based on Pender's Health Promotion Model on Fall Behaviors, Fear of Falling, and Self-Efficacy'
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fear of Falling Scale
Time Frame: From enrollment to the end of treatment at 12 weeks.
|
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.
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From enrollment to the end of treatment at 12 weeks.
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Self-Efficacy/Competence Scale
Time Frame: From enrollment to the end of treatment at 12 weeks
|
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.
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From enrollment to the end of treatment at 12 weeks
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Fall Behavior Scale for the Elderly
Time Frame: From enrollment to the end of treatment at 12 weeks
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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
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From enrollment to the end of treatment at 12 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025.12.19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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