Caregiver BurdenCare BurdenNCT07672340
Care Burden And Qualıty of Lıfe
A study testing Health Promotion Behavior Education in people with Caregiver Burden and Quality of Life, run by Aydin Adnan Menderes University.
Trial summary
This randomized controlled trial will be conducted to examine the effect of a multidimensional training program, to be implemented by a public health nurse, on the care burden and quality of life of primary caregivers of patients aged 65 and older. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden, Quality of Life, Public Health
- What is being tested?
- Health Promotion Behavior Education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Mar 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing to participate in the study
- Be literate
- Have registered with a home health care unit
- Have been responsible for the care of a relative aged 65 or older for at least one month
- Score at least 21 on the Zarit Caregiver Burden Scale
Who cannot join
- • Having severe reading comprehension difficulties
- Having severe hearing difficulties
- Having been diagnosed with a psychiatric disorder (schizophrenia, bipolar disorder, or anxiety disorder)
- Failing to complete the data collection instruments used in the study
- Failing to attend at least two training sessions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect Of Multıdımensıonal Traınıng Applıed to Caregıvers of Home Health Servıce Recıpıents Aged 65 And Over on Care Burden And Qualıty of Lıfe
This randomized controlled trial will be conducted to examine the effect of a multidimensional training program, to be implemented by a public health nurse, on the care burden and quality of life of primary caregivers of patients aged 65 and older.
- Conditions
- Caregiver Burden, Quality of Life, Public Health
- Being tested
- Health Promotion Behavior Education
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Promotion Behavior EducationBehavioural
Also called Social health dimension, Physical health, Psychological health dimension, Emotional health dimension
Personal hygiene, hand hygiene, Musculoskeletal system, body mechanics, relaxation exercises, the importance of physical activity, Proper and healthy nutrition, foods to increase and decrease consumption of, food safety and hygiene, Sleep health, sleep hygiene, the importance of sleep in human life, sleep quality, sleep duration, and factors affecting sleep, Early detection methods, adult immunization, rational use of medications, Safe environment and home accidents.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group continued to receive the routine care |
| Structured education | Experimental | Caregivers in the intervention groups will undergo a four-session intervention program in addition to the routine care provided by other caregivers. The training, which is planned to last four weeks and includes activities aimed at reducing the impact of the caregiving role on caregivers, involves the delivery of a training program designed to improve caregivers' adaptation to their caregiving roles. Receives: Behavioral: Health Promotion Behavior Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Before intervention caregiving burden
The Caregiver Burden Scale will be used to assess the stress experienced by caregivers.
It consists of 22 statements that evaluate the impact of caregiving on the caregiver's life and uses a Likert-type scale. The scale's highest score is 88, and the lowest is 0. Higher scores are associated with an increased caregiving burden.
Measured: Before intervention
After intervention caregiving burden
The Caregiver Burden Scale will be used to assess the stress experienced by caregivers. It consists of 22 statements that assess the impact of caregiving on the caregiver's life and uses a Likert-type scale. The maximum score on the scale is 88, and the minimum is 0. Higher scores are associated with increased caregiving burden.
Measured: 1 week after intervention
Secondary outcomes (2)
Before intervention
Pre-Intervention Life Satisfaction This scale was developed to assess how an individual perceives their quality of life. The scale was created by condensing the World Health Organization Quality of Life Assessment scale to 26 questions. During the validity studies of the Turkish version, a national question was added, bringing the total number of questions to 27, and the Turkish version was finalized. Comprising closed-ended questions, the scale consists of the following subdimensions: general health, physical, social, environmental, and psychological. The minimum score that can be obtained from the scale is 0, and the maximum score is 100. An increase in the score indicates an improvement in quality of life.
Measured: Before intervention
After intervention
Post-Intervention Life Satisfaction This scale was developed to assess how an individual perceives their quality of life. The scale was created by condensing the World Health Organization Quality of Life Assessment scale to 26 questions. During the validity studies of the Turkish version, a national question was added, bringing the total number of questions to 27, and the Turkish version was finalized. Comprising closed-ended questions, the scale consists of the following subdimensions: general health, physical, social, environmental, and psychological. The minimum score that can be obtained from the scale is 0, and the maximum score is 100. An increase in the score indicates an improvement in quality of life.
Measured: 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Hassoy, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672340
- Sponsor's protocol ID
- 10.01.2024-1389-1409
- Other IDs
- HF-24005
- Acronym
- Care Burden
- Status last verified
- Oct 2026
- First submitted
- 8 May 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Multıdımensıonal Traınıng Applıed to Caregıvers of Home Health Servıce Recıpıents Aged 65 And Over on Care Burden And Qualıty of Lıfe
- ClinicalTrials.gov ID
- NCT07672340
- Acronym / sponsor ID
- Care Burden / 10.01.2024-1389-1409
- Conditions
- Caregiver Burden, Quality of Life, Public Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 Jun 2026 (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.
This randomized controlled trial will be conducted to examine the effect of a multidimensional training program, to be implemented by a public health nurse, on the care burden and quality of life of primary caregivers of patients aged 65 and older.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group continued to receive the routine care |
| Structured education | Experimental | Behavioral: Health Promotion Behavior EducationCaregivers in the intervention groups will undergo a four-session intervention program in addition to the routine care provided by other caregivers. The training, which is planned to last four weeks and includes activities aimed at reducing the impact of the caregiving role on caregivers, involves the delivery of a training program designed to improve caregivers' adaptation to their caregiving roles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be willing to participate in the study
- Be literate
- Have registered with a home health care unit
- Have been responsible for the care of a relative aged 65 or older for at least one month
- Score at least 21 on the Zarit Caregiver Burden Scale
Key exclusion criteria (5 listed)
- • Having severe reading comprehension difficulties
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 Promotion Behavior EducationAlso: Social health dimension, Physical health, Psychological health dimension, Emotional health dimensionPersonal hygiene, hand hygiene, Musculoskeletal system, body mechanics, relaxation exercises, the importance of physical activity, Proper and healthy nutrition, foods to increase and decrease consumption of, food safety and hygiene, Sleep health, sleep hygiene, the importance of sleep in human life, sleep quality, sleep duration, and factors affecting sleep, Early detection methods, adult immunization, rational use of medications, Safe environment and home accidents. | Behavioural | Structured education |
Primary outcome
Before intervention caregiving burden
Time frame: Before intervention
The Caregiver Burden Scale will be used to assess the stress experienced by caregivers. It consists of 22 statements that evaluate the impact of caregiving on the caregiver's life and uses a Likert-type scale. The scale's highest score is 88, and the lowest is 0. Higher scores are associated with an increased caregiving burden.
After intervention caregiving burden
Time frame: 1 week after intervention
The Caregiver Burden Scale will be used to assess the stress experienced by caregivers. It consists of 22 statements that assess the impact of caregiving on the caregiver's life and uses a Likert-type scale. The maximum score on the scale is 88, and the minimum is 0. Higher scores are associated with increased caregiving burden.
2 secondary outcomes
Before intervention
Time frame: Before intervention
After intervention
Time frame: 1 week after intervention
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 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Health Promotion Behavior Education in people with Caregiver Burden and Quality of Life, run by Aydin Adnan Menderes University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Dilek Hassoy (+905054829071, dihassoy09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Before intervention caregiving burden (time frame: Before intervention). 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 2 Nov 2026.