- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07547358
Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
The Impact of a Digital Training Model Developed Using Animation Technique on Risk Knowledge Level and Frailty Among Older Adults
With the global aging trend, the management of geriatric risks faced by older adults and the effectiveness of health education for this population are gaining increasing importance. Literature indicates that health education for older adults, when delivered through methods that support individual engagement and the use of digital tools, yields more effective results in terms of learning and behavior change. This doctoral study aims to evaluate the effect of a digital education model, structured based on the Health Belief Model and developed using branching scenario animation technique, on geriatric risk knowledge level and frailty status among older adults residing in nursing homes.
The study will be conducted as a randomized controlled trial in three nursing homes in Istanbul, with measurements at baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3). Based on power analysis, 66 participants will be randomly assigned to intervention and control groups (33 per group) using block randomization. The intervention group will receive scenario-based digital animation education developed on the Vyond platform and structured according to the theoretical components of the Health Belief Model. The control group will receive standard care during the study period and will be offered the same digital animation education after completion of all assessments (post 3-month follow-up).
The primary outcome is geriatric risk knowledge level, assessed using an interactive digital game called "Knowledge Wheel." Secondary outcomes include frailty status, measured by the Edmonton Frail Scale, and technology acceptance. Changes in knowledge and frailty levels measured through assessment tools will reveal the short- and medium-term effects of the education. Thus, the model's impact on health-related behavior change in older adults will be comprehensively evaluated.
The unique aspect of this study is that it will be one of the first experimental studies to implement an interactive scenario-based digital education model in older adults. The findings are expected to contribute to the development of age-friendly health education models.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: ELIF PAKLACI YORMAZ, MSc
- Numer telefonu: +9021261010
- E-mail: elif.paklaci@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: BESEY OREN, PhD
- Numer telefonu: +90 216 777 8 777
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Aged 65 years or older
- Ability to speak and understand Turkish
- Minimum literacy level (able to read and write)
- Mini-Mental State Examination (MMSE) score ≥ 24
- No visual or auditory impairment, or ability to compensate for such impairments with assistive devices
- Ability to interact with digital devices such as smartphones or tablets at a basic level
Exclusion Criteria:
- Diagnosis of cognitive impairment or dementia
WITHDRAWAL CRITERIA:
- Participants will be withdrawn from the study if:
- Serious health problems occur during any phase of the study or death occurs
- Perception or compliance problems are identified during sessions
- The participant fails to attend at least one educational session
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Intervention Group
Participants will receive branching scenario-based digital animation education developed using Vyond platform and structured according to Health Belief Model components. The education addresses geriatric health risks including falls, malnutrition, polypharmacy, and cognitive decline through interactive scenarios. Assessments will be conducted at baseline (T0), immediate post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3). |
An interactive digital education program developed on Vyond animation platform, based on Health Belief Model framework. The program includes branching scenarios on geriatric health risks (falls, nutrition, medication safety, cognitive health, social engagement). Participants make choices within scenarios and receive personalized feedback. Each session lasts approximately 30-45 minutes. The intervention uses interactive storytelling to enhance engagement and knowledge retention among older adults. |
|
Brak interwencji: Control Group
Participants will receive standard nursing home care during the study period. No additional educational intervention will be provided during the study. The same digital animation education will be offered after completion of all assessments (post 3-month follow-up). Assessments will be conducted at baseline (T0), T1, T2, and T3 time points. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Geriatric Risk Knowledge Level
Ramy czasowe: Measured at baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3) - approximately 4 months total
|
Change in knowledge score related to geriatric health risks (falls, medication management, nutrition, cognitive health, social engagement) assessed using an interactive digital game called "Knowledge Wheel". The assessment evaluates participants' understanding of risk factors, prevention strategies, and health-promoting behaviors based on Health Belief Model components. |
Measured at baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3) - approximately 4 months total
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Frailty Status
Ramy czasowe: Measured at baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3) - approximately 4 months total
|
Change in frailty level measured by the Edmonton Frail Scale (EFS). The scale assesses nine domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance. Scores range from 0-17, with higher scores indicating greater frailty. |
Measured at baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3) - approximately 4 months total
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: ELIF PAKLACI YORMAZ, MSc, Saglik Bilimleri Universitesi
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 425S786
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Individual participant data will not be shared due to privacy protection regulations under Turkish Personal Data Protection Law (KVKK) and institutional ethics committee restrictions. The study involves vulnerable population (older adults in nursing homes) with sensitive health information. Aggregate results and findings will be disseminated through peer-reviewed publications and conference presentations.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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