- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06419465
SCT-Based Health Promotion in Older Adults
Comparison of the Effects of Social Cognitive Theory-Based Peer- and Nurse-Led Health Promotion and Prevention Education Programs on the Health Behavıors of Older Adults: A Study Protocol
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Antalya, Turkey (Türkiye), 07070
- Department of Public Health Nursing, Faculty of Nursing, Akdeniz University, Antalya, Türkiye
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Older adults aged 65 and over classified as low (for women: 0-4 points; for men: 0-3 points) or moderate (for women: 5-8 points; for men: 4-6 points) according to the Health Promotion and Prevention Behavior Checklist,
- Those who attend the elderly center where the study will be conducted at least once a week,
- Those who reside in the study province,
- Those who have and can use a smartphone,
- Those who can speak and understand Turkish,
- Those who scored nine or above on the Short Form of the Mini Mental State Examination (MMSE) (considered to have sufficient cognitive status to participate in the interview),
- Those who scored three or above on the Katz Activities of Daily Living (ADL) Scale (semi-dependent and independent),
- Those who agreed to participate in the study voluntarily,
- Only one older adult from the same household was included in the study.
Exclusion Criteria:
• Those who had previously participated in similar studies related to health promotion and prevention were not included in the study.
Withdrawal and Loss to Follow-up Criteria
- Those who wished to withdraw from the study,
- Those who moved to another location outside the study setting,
- Those who were hospitalized for more than one week due to various reasons during the study period,
- Those who, according to their own statement, had a general health condition not suitable to continue the study,
- Those who died during the study period,
- Those who completed the pre-test but did not participate in the interventions were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Peer-Led Health Protection and Promotion Training Program
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The Peer-Led Health Protection and Promotion Training Program based on SCT aims to improve health behaviors, increase self-efficacy, and promote appropriate health-seeking behaviors among older adults with low or moderate levels of health promotion practices.
Implemented in the Intervention-1 group, this program is defined as the ÖNDER (Self-efficacious Individuals-Qualified Guidance-Experience Sharing-Active Participation-Role Model) Program and was developed according to the Taba-Tyler Model.
The program includes interactive group education; demonstration and guided use of Google Fit and E-Pulse applications; WhatsApp groups for peer interaction; peer walking activities; individual phone calls; digital reminders (messages, brochures, videos); peer meetings; and achievement badges.
Interventions will be conducted by peer leaders in the workshop classroom and garden of the elderly home.
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Experimental: Health Protection and Promotion Training Program under the Leadership of a Public Health Nurse
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The SCT-based Nurse-Led Health Protection and Promotion Training Program implemented in the Intervention-2 Nurse Leadership group has the same aim, duration, and weekly plan as the Intervention-1 Peer Leadership group and is conducted under nurse leadership.
The program applied to the Intervention-2 Nurse Leadership group is briefly defined as the REHBER (Reflection-Education-Nurse Leadership-Information-Activation-Routine Formation) Program.
The SCT-based Health Protection and Promotion Training Program provided to this group was also developed according to the Taba-Tyler Model.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Elderly Health Promotion Scale
Time Frame: Change in health promotion behavior assessment score from baseline to week 12
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The Elderly Health Promotion Scale, developed by Wang et al. (2015), assesses health-promoting behaviors in individuals aged 65 and over and consists of 22 items and six subdimensions. Its Turkish validity and reliability were established by Gulsoy and Senturan (2020). The subdimensions include Health Behaviors, Participation in Society, Health Responsibility, Healthy Eating, Regular Exercise, and Oral Health. The four-point Likert scale ranges from "never" (1) to "always" (4), with total scores between 22 and 88; higher scores indicate greater engagement in health-promoting behaviors. Subscale scores are obtained by summing relevant items. Cronbach's alpha coefficients ranged from 0.80 to 0.91 for subdimensions, with an overall reliability of 0.85 (Gulsoy and Senturan, 2020). |
Change in health promotion behavior assessment score from baseline to week 12
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Health Promotion and Prevention Behavior Checklist
Time Frame: Change in health promotion and prevention behaviors from baseline to week 12
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This form was developed based on the literature to assess health promotion and prevention behaviors among individuals aged 65 and over (Gulsoy and Senturan, 2020; Ministry of Health, 2023).
It includes items on the Elderly Health Promotion Scale, immunization, chronic disease screenings, smoking, obesity, and cancer screenings.
Responses are coded as "Yes: 1" and "No: 0." Based on total scores, behaviors are classified as low, moderate, or high, with gender-specific cut-off points.
Additionally, health promotion behavior is evaluated as insufficient or sufficient according to the scale score.
Content validity was established using the Davis technique with input from 10 experts, yielding a high CVI of 0.96 (Davis, 1992).
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Change in health promotion and prevention behaviors from baseline to week 12
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General Self-Efficacy Scale
Time Frame: Change in general self-efficacy score from baseline to week 12
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The General Self-Efficacy Scale, developed by Jerusalem and Schwarzer and later revised to 10 items, was adapted into Turkish by Aypay (2010).
It is a four-point Likert scale (1=not at all true to 4=completely true), with total scores ranging from 10 to 40; higher scores indicate greater self-efficacy.
The Cronbach's alpha coefficient is 0.83.
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Change in general self-efficacy score from baseline to week 12
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Health-Seeking Behavior Scale
Time Frame: Change in health-seeking behavior score from baseline to week 12
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The Health-Seeking Behavior Scale, developed by Kirac and Ozturk (2021), consists of 12 items across three subdimensions: online, professional, and traditional seeking behaviors.
It is a five-point Likert scale (1=strongly disagree to 5=strongly agree), where higher mean scores indicate greater health-seeking behavior.
The scale's Cronbach's alpha coefficient is 0.76.
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Change in health-seeking behavior score from baseline to week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Google Fit Mobile Application Use Checklist
Time Frame: Change in Google Fit Mobile Application Use Checklist score from baseline to week 12
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The Google Fit Mobile Application Use Checklist consists of six items assessing the ability to log into the mobile application, start the application while walking, access the average walking duration (daily, weekly, and monthly) through the application, and set walking goals (in terms of duration).
The responses to the checklist, which was developed based on the features available in the mobile application, were recorded as "Yes" and "No," and the use of the Google Fit mobile application among older adults was evaluated using an objective measurement tool.
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Change in Google Fit Mobile Application Use Checklist score from baseline to week 12
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E-Pulse Mobile Application Use Checklist
Time Frame: Change in E-Pulse Mobile Application Use Checklist score from baseline to week 12
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The E-Pulse Mobile Application Use Checklist consists of 24 items and was developed based on the features available in the E-pulse mobile application.
The responses to this checklist were recorded as "Yes" and "No," and the use of the E-Pulse mobile application among older adults was evaluated using an objective measurement tool.
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Change in E-Pulse Mobile Application Use Checklist score from baseline to week 12
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
Keywords
Other Study ID Numbers
- 0286
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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