Sense of CoherenceNCT07130435
The Effect of Salutogenes-Based Nursing Intervention on Older Adults
A study testing Salutogenic Model-Based Healthy Aging Program in people with Sense of Coherence, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Sense of Coherence
- What is being tested?
- Salutogenic Model-Based Healthy Aging Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2025to 25 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gülçin KURT
Ankara, 06630
Gülçin KURT, phd, +905417885573, gulcinkurt86@gmail.com
Esma ATASOY, Assosiate prof., 05342795511, esm.akf@gmail.com
About this study
Official title: The Effect of Nursing Intervention Based on the Salutogenic Model on Sense of Coherence, Healthy Aging, and Quality of Life
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.
Read the detailed description
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 investigators 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 increase in the elderly population brings about various health, economic, social, and environmental challenges. In order to address these issues, societies are not only developing care and treatment methods for the elderly but are also giving importance to prevention methods. The ability to live independently is essential for healthy aging and maintaining a healthy population. To support the elderly in living independently, both preventive and therapeutic methods are used. This is because, alongside long life, the quality of life is also of great importance (Gürer et al., 2019). From the perspective of the National Action Plan on Aging, health problems emerge or existing issues are exacerbated with aging, thereby affecting living standards. In addition to the physical changes seen in this period, health problems related to chronic diseases also negatively impact the quality of life.
The increase in life expectancy at birth has contributed to the global increase in the elderly population (onikinciplan.sbb.gov.tr). 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
- Page 2 of 5 [DRAFT] - 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. Research Hypotheses Hypothesis 1. H1: There is a difference in the average quality of life scores between elderly individuals in the intervention and control groups. Hypothesis 2. H1: There is a difference in the average sense of wholeness scores between elderly individuals in the intervention and control groups. Hypothesis 2a. H1: There is a difference in the average comprehensibility subscale scores of the sense of wholeness between elderly individuals in the intervention and control groups. Hypothesis 2b. H1: There is a difference in the average meaningfulness subscale scores of the sense of wholeness between elderly individuals in the intervention and control groups. Hypothesis 2c. H1: There is a difference in th
- Conditions
- Sense of Coherence
- Being tested
- Salutogenic Model-Based Healthy Aging Program
- Keywords
- Salutogenesis, elderly people, public health nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salutogenic Model-Based Healthy Aging ProgramBehavioural
Also called educational intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline (pre-intervention) and immediately after the intervention (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start31 Jan 2025
- Primary completion25 Jun 2026 (estimated)
- Study completion25 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sense of CoherenceStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin Kurt, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130435
- Sponsor's protocol ID
- 10-513
- Status last verified
- Aug 2025
- First submitted
- 5 May 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data (IPD) for this study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Intervention Based on the Salutogenic Model on Sense of Coherence, Healthy Aging, and Quality of Life
- ClinicalTrials.gov ID
- NCT07130435
- Acronym / sponsor ID
- 10-513
- Conditions
- Sense of Coherence
- Keywords
- Salutogenesis, elderly people, public health nursing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 25 Jul 2026 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 investigators 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 increase in the elderly population brings about various health, economic, social, and environmental challenges. In order to address these issues, societies are not only developing care and treatment methods for the elderly but are also giving importance to prevention methods. The ability to live independently is essential for healthy aging and maintaining a healthy population. To support the elderly in living independently, both preventive and therapeutic methods are used. This is because, alongside long life, the quality of life is also of great importance (Gürer et al., 2019). From the perspective of the National Action Plan on Aging, health problems emerge or existing issues are exacerbated with aging, thereby affecting living standards. In addition to the physical changes seen in this period, health problems related to chronic diseases also negatively impact the quality of life.
The increase in life expectancy at birth has contributed to the global increase in the elderly population (onikinciplan.sbb.gov.tr). 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
- Page 2 of 5 [DRAFT] - 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. Research Hypotheses Hypothesis 1. H1: There is a difference in the average quality of life scores between elderly individuals in the intervention and control groups. Hypothesis 2. H1: There is a difference in the average sense of wholeness scores between elderly individuals in the intervention and control groups. Hypothesis 2a. H1: There is a difference in the average comprehensibility subscale scores of the sense of wholeness between elderly individuals in the intervention and control groups. Hypothesis 2b. H1: There is a difference in the average meaningfulness subscale scores of the sense of wholeness between elderly individuals in the intervention and control groups. Hypothesis 2c. H1: There is a difference in th
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Salutogenic Model-Based Healthy Aging ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salutogenic Model-Based Healthy Aging ProgramAlso: educational interventionThe 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. | Behavioural | Intervention Group |
Primary outcome
Quality of Life (QoL):
Time frame: Measured at baseline (pre-intervention) and immediately after the intervention (post-intervention).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data (IPD) for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salutogenic Model-Based Healthy Aging Program in people with Sense of Coherence, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gülçin KURT, PHD (+905417885573, gulcinkurt86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QoL): (time frame: Measured at baseline (pre-intervention) and immediately after the intervention (post-intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.