Disease Self ManagementNCT06346964
Self-Care Management in Chronic Disease
A study testing Health education in people with Disease Self Management, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
Self-management of chronic diseases includes treatment and adoption of healthy behaviors. The research was planned to determine the effect of health education on disease management in the elderly with chronic diseases. The research will be conducted in a parallel group, randomized controlled manner. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Disease Self Management
- What is being tested?
- Health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being in the 65-75 age group,
- Having a chronic disease
Who cannot join
- Having vision and hearing problems
- Being 76 or older
- Having a neuro-psychiatric disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University
Ankara, Çubuk/Turkey, 06760
About this study
Official title: The Effect of Health Education on Chronic Disease Management in the Elderly
Self-management of chronic diseases includes treatment and adoption of healthy behaviors. The research was planned to determine the effect of health education on disease management in the elderly with chronic diseases. The research will be conducted in a parallel group, randomized controlled manner. Older adults will receive 6 weeks of health education. After the training, the scales will be re-administered face to face or online.
- Conditions
- Disease Self Management
- Being tested
- Health education
- Keywords
- elderly, self management, chronic disease
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationOther
Health education prepared for chronic disease self-management aims to improve the health behaviors of older adults.
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | 6 weeks of health education will be provided to older adults. Once the intervention is completed, the scales will be re-administered face-to-face or online. Receives: Other: Health education |
| Control | No intervention | No intervention has been made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Disease Self-Management Scale
The scale, developed to evaluate self-management in chronic diseases, consists of 23 items and four subscales: Self-Stigma, Coping with Stigma, Health Care Effectiveness and Treatment Compliance. Expressions on the scale are rated between 1-5; It can be converted into a 100-point system (1=0, 2=25, 3=50 and 4=75 and 5=100) to facilitate interpretation and comparison in evaluation. A high score in the Self-Stigma subscale indicates high self-stigma, a high score in the Coping with Stigma subscale indicates a high ability to cope with stigma, a high score in Health Care Effectiveness indicates high health care effectiveness, and a high score in Treatment Compliance indicates good compliance. It was determined that the 21-item scale, adapted to Turkish in 2021, showed a four-factor structure and Cronbach alpha coefficients ranged between 0.789 and 0.876.
Measured: baseline
Chronic Disease Self-Management Scale
The scale, developed to evaluate self-management in chronic diseases, consists of 23 items and four subscales: Self-Stigma, Coping with Stigma, Health Care Effectiveness and Treatment Compliance. Expressions on the scale are rated between 1-5; It can be converted into a 100-point system (1=0, 2=25, 3=50 and 4=75 and 5=100) to facilitate interpretation and comparison in evaluation. A high score in the Self-Stigma subscale indicates high self-stigma, a high score in the Coping with Stigma subscale indicates a high ability to cope with stigma, a high score in Health Care Effectiveness indicates high health care effectiveness, and a high score in Treatment Compliance indicates good compliance. It was determined that the 21-item scale, adapted to Turkish in 2021, showed a four-factor structure and Cronbach alpha coefficients ranged between 0.789 and 0.876.
Measured: within first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start22 Apr 2024 (estimated)
- Primary completion22 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Why it stopped: There were not enough participants for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease Self ManagementStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Akca, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346964
- Sponsor's protocol ID
- 2023-031
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Education on Chronic Disease Management in the Elderly
- ClinicalTrials.gov ID
- NCT06346964
- Acronym / sponsor ID
- 2023-031
- Conditions
- Disease Self Management
- Keywords
- elderly, self management, chronic disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There were not enough participants for the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 22 Apr 2024 (estimated)
- Primary completion
- 22 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Apr 2024 (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.
Self-management of chronic diseases includes treatment and adoption of healthy behaviors. The research was planned to determine the effect of health education on disease management in the elderly with chronic diseases. The research will be conducted in a parallel group, randomized controlled manner. Older adults will receive 6 weeks of health education. After the training, the scales will be re-administered face to face or online.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Other: Health education6 weeks of health education will be provided to older adults. Once the intervention is completed, the scales will be re-administered face-to-face or online. |
| Control | No intervention | –No intervention has been made. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Being in the 65-75 age group,
- Having a chronic disease
Key exclusion criteria (3 listed)
- Having vision and hearing problems
- Being 76 or older
- Having a neuro-psychiatric disease
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 |
|---|---|---|
| Health educationHealth education prepared for chronic disease self-management aims to improve the health behaviors of older adults. | Other | Education |
Primary outcome
Chronic Disease Self-Management Scale
Time frame: baseline
The scale, developed to evaluate self-management in chronic diseases, consists of 23 items and four subscales: Self-Stigma, Coping with Stigma, Health Care Effectiveness and Treatment Compliance. Expressions on the scale are rated between 1-5; It can be converted into a 100-point system (1=0, 2=25, 3=50 and 4=75 and 5=100) to facilitate interpretation and comparison in evaluation. A high score in the Self-Stigma subscale indicates high self-stigma, a high score in the Coping with Stigma subscale indicates a high ability to cope with stigma, a high score in Health Care Effectiveness indicates high health care effectiveness, and a high score in Treatment Compliance indicates good compliance. It was determined that the 21-item scale, adapted to Turkish in 2021, showed a four-factor structure and Cronbach alpha coefficients ranged between 0.789 and 0.876.
Chronic Disease Self-Management Scale
Time frame: within first week
The scale, developed to evaluate self-management in chronic diseases, consists of 23 items and four subscales: Self-Stigma, Coping with Stigma, Health Care Effectiveness and Treatment Compliance. Expressions on the scale are rated between 1-5; It can be converted into a 100-point system (1=0, 2=25, 3=50 and 4=75 and 5=100) to facilitate interpretation and comparison in evaluation. A high score in the Self-Stigma subscale indicates high self-stigma, a high score in the Coping with Stigma subscale indicates a high ability to cope with stigma, a high score in Health Care Effectiveness indicates high health care effectiveness, and a high score in Treatment Compliance indicates good compliance. It was determined that the 21-item scale, adapted to Turkish in 2021, showed a four-factor structure and Cronbach alpha coefficients ranged between 0.789 and 0.876.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education in people with Disease Self Management, 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 10 Jul 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Disease Self-Management Scale (time frame: baseline). The study lists 2 primary outcomes in all. 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 10 Jul 2024.