NCT07130435

Brief Summary

The world population is rapidly aging, and Turkey is one of the countries where aging is occurring quickly. When the investigators examine the proportion of the elderly population to the total population over the years and decades, the invesitigators observe that the percentage was 3.9% in 1935, 3.4% in 1955, 4.1% in 1975, 5.7% in 2000, 7.2% in 2010, 7.7% in 2013, and 8.5% in 2017. Finally, in 2022, this proportion reached 9.9%. According to population projections, the proportion of the elderly population is expected to be 12.9% in 2030, 16.3% in 2040, 22.6% in 2060, and 25.6% in 2080 (TUIK, 2022). The ability of elderly individuals to live independently is influenced by their social and economic conditions, physical health, as well as sociodemographic characteristics such as age and gender. The interaction of elderly individuals with society influences their healthy living behaviors. Furthermore, their interaction with personal and societal resources affects their sense of wholeness and quality of life. To achieve a good quality of life, elderly individuals need to use both internal and external resources, and education should support this (Tan et al., 2014). For health services to be effective, they must be sensitive to the differences, experiences, socioeconomic status, and cultural background of individuals. Therefore, health professionals, including nurses, should prioritize providing appropriate health services for elderly individuals during care (Temel et al., 2009). The roles of public health nurses in elderly health include providing education to elderly individuals and caregivers, offering counseling, protecting the health of elderly individuals, conducting physical assessments, teaching self-care and personal hygiene, making home visits when necessary, assessing and taking precautions regarding situations that could cause accidents, evaluating acute health problems and chronic diseases, educating about the management of chronic diseases, and implementing interventions based on nursing diagnoses (Akdemir et al., 2009). The most important principle in ensuring elderly individuals maintain their health and age healthily is to support them in acquiring basic living skills and independence as much as possible. These basic skills, also known as daily living activities, are crucial for preserving the quality of life by enabling elderly individuals to live independently. A review of the literature reveals that there is no evidence of educational or intervention programs aimed at supporting healthy aging for individuals aged 65 and over in Turkey, or programs that focus on holistic health. Therefore, this randomized controlled study will investigate how an intervention and education program based on the salutogenic model affects elderly individuals' self-efficacy, healthy living behaviors, and coping skills with diseases and stressors. As a result, the applied intervention program will positively impact the quality of life, sense of wholeness, and healthy aging processes of elderly individuals by examining their responses to stressors and revealing the internal and external resources they can utilize.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jan 2025Jul 2026

Study Start

First participant enrolled

January 31, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2026

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

May 5, 2025

Last Update Submit

August 15, 2025

Conditions

Keywords

Salutogenesis, elderly people, public health nursing

Outcome Measures

Primary Outcomes (1)

  • Quality of Life (QoL):

    The secondary primary outcome will be changes in the participants' quality of life, assessed through a standardized QoL scale, focusing on physical, mental, and social well-being.

    Measured at baseline (pre-intervention) and immediately after the intervention (post-intervention).

Other Outcomes (1)

  • Sense of Coherence (SOC):

    Measured at baseline (pre-intervention) and immediately after the intervention (post-intervention).

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in this group will receive an intervention based on the salutogenic model, aimed at enhancing the sense of coherence and promoting healthy aging. The program will focus on improving participants' overall quality of life by strengthening their internal resources and fostering resilience. The intervention will include educational sessions, guided discussions, and practical strategies for maintaining physical and mental health in older adults with hypertension and diabetes. The intervention will be delivered over a specified period, with regular follow-ups to assess progress.

Behavioral: Salutogenic Model-Based Healthy Aging Program

control group

NO INTERVENTION

Participants in this group will receive standard care as provided by the nursing homes, without any additional intervention based on the salutogenic model. They will continue to receive routine support and healthcare services that are typically available to older adults in the facility, including management of hypertension and diabetes. This group will be monitored for any changes in quality of life and sense of coherence over the course of the study, but no specific program or educational sessions will be provided.

Interventions

The Salutogenic Model-Based Healthy Aging Program is designed to enhance the sense of coherence and promote healthy aging among older adults aged 60-70. The program focuses on strengthening participants' internal resources, building resilience, and improving overall quality of life. It includes educational sessions, group discussions, and practical strategies for managing hypertension and diabetes, all while emphasizing physical, emotional, and mental well-being. The program aims to empower participants to make informed lifestyle choices and cope with the challenges of aging. Participants will receive regular follow-up assessments to track progress and ensure continued support throughout the study period.

Also known as: educational intervention
Intervention Group

Eligibility Criteria

Age60 Years - 70 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIf you plan to analyze the outcomes based on gender (e.g., assessing whether the intervention has a different impact on men vs. women).
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 60 and 70 years.
  • Residing in nursing homes affiliated with the Turkish Ministry of Family and Social Services in Ankara.
  • A minimum score of 24 on the Mini-Mental State Examination (MMSE).
  • Diagnosed with Diabetes Mellitus (DM) or Hypertension (HT) for at least the past 3 years.

You may not qualify if:

  • Known cognitive impairment or difficulty in perception.
  • Severe hearing or vision impairment.
  • Inability to participate in the study due to activity intolerance.
  • Inability to perform daily living activities independently.
  • Weight loss greater than 3 kg in the past month.
  • Presence of incontinence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gülçin KURT

Ankara, 06630, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Central Study Contacts

Gülçin KURT, PHD

CONTACT

Esma ATASOY, Ass. prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking will be applied in this study. Both participants and researchers will be aware of the assigned groups due to the nature of the intervention.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study is a randomized controlled intervention using a pretest-posttest experimental design. Participants will be 72 older adults aged 60-70 residing in nursing homes affiliated with the Turkish Ministry of Family and Social Services in Ankara. They will be randomly assigned to either an intervention (n=36) or control (n=36) group. The study aims to evaluate the effect of an intervention based on the salutogenic model on sense of coherence, healthy aging, and quality of life.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2025

First Posted

August 19, 2025

Study Start

January 31, 2025

Primary Completion (Estimated)

June 25, 2026

Study Completion (Estimated)

July 25, 2026

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

We do not plan to share individual participant data (IPD) for this study.

Locations