EducationNCT06182930
Education of Caregivers of Alzheimer's Patients
A study testing Within the scope of the research, caregivers will be given face-to-face training in 2 sessions, 15 days apart. in people with Education, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Purpose of the Research: This study will be conducted to determine the effect of the education given to caregivers of Alzheimer's patients registered to home health services on their knowledge and attitudes towards Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Education
- What is being tested?
- Within the scope of the research, caregivers will be given face-to-face training in 2 sessions, 15 days apart.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Aug 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who are primarily responsible for the care of the patient diagnosed with Alzheimer's disease,
- Caring for a patient diagnosed with Alzheimer's disease for at least 6 months,
- Ages 18 and over,
- The one who is literate,
- Open to communication and collaboration,
- Caregivers who volunteer to participate in the study will be included in the study.
Who cannot join
- Cannot understand and speak Turkish,
- Those with mental and cognitive retardation and
- Caregivers who do not want to continue the research will be excluded from the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Given to Caregivers of Alzheimer's Patients Registered With Home Health Services on Their Knowledge and Attitudes Towards Alzheimer's Disease: Randomized Controlled Study
Purpose of the Research: This study will be conducted to determine the effect of the education given to caregivers of Alzheimer's patients registered to home health services on their knowledge and attitudes towards Alzheimer's disease.
Hypotheses of the Research H01: The education given to caregivers of Alzheimer's patients registered to home health services does not affect the caregivers' level of knowledge about Alzheimer's disease.
Read more
H11: The education given to caregivers of Alzheimer's patients registered to home health services increases the caregivers' level of knowledge about Alzheimer's disease.
H02: The education given to caregivers of Alzheimer's patients registered to home health services does not affect the caregivers' attitudes towards Alzheimer's disease.
H12: The education given to caregivers of Alzheimer's patients registered to home health services positively affects the caregivers' attitudes towards Alzheimer's disease.
Read the detailed description
-The number of elderly population is increasing in the world and in Turkey. Dementia increases with age. The most common type of dementia is Alzheimer's disease. As the Alzheimer's disease stage progresses, patients' dependency level in daily living activities increases and they need care support. Alzheimer's patients are usually cared for at home by family members. Caregivers may experience many difficulties in the home environment due to lack of knowledge in disease management. This study will be conducted to determine the effect of the education given to caregivers of Alzheimer's patients registered to home health services on their knowledge and attitudes towards Alzheimer's disease. The research was planned as a single-blind randomized controlled experimental study. The research will be conducted on caregivers of Alzheimer's patients registered to Giresun Province Bulancak State Hospital Home Health Services between 20 December 2023 and 20 December 2024. The population of the research will be the caregivers of Alzheimer's patients registered to Giresun Province Bulancak State Hospital Home Health Services. The sample of the research will be the caregivers of 60 patients who meet the research criteria and agree to participate in the research. The data of the study will be collected with the "Patient and Caregiver Introduction Form", "Alzheimer's Disease Information Scale" and "Dementia Attitude Scale". Necessary institutional permissions and ethics committee approval will be obtained for the research. In the research, caregivers in the experimental group will be trained about Alzheimer's disease in 2 sessions, 15 days apart, in the training hall of the hospital. No intervention will be applied to caregivers in the control group during the research. Necessary institutional permission and ethics committee approval will be obtained for the research. The analysis of the data will be done in a computer environment by an expert statistician.
- Conditions
- Education
- Being tested
- Within the scope of the research, caregivers will be given face-to-face training in 2 sessions, 15 days apart.
- Keywords
- Alzheimer, Caregiver, Knowledge, Attitude, Education
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Within the scope of the research, caregivers will be given face-to-face training in 2 sessions, 15 days apart.Other
Also called No Intervention
They will receive routine home health care follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Within the scope of the research, caregivers will be given face-to-face training in 2 sessions, 15 days apart. Receives: Other: Within the scope of the research, caregivers will be given face-to-face training in 2 sessions, 15 days apart. |
| Control | No intervention | They will receive routine home health care follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Knowledge Scale
The scale developed by Carpenter et al. (2009) was adapted to Turkish by Yılmaz and Çolak (2020). The scale consists of 30 items and evaluates people's level of knowledge about Alzheimer's disease. Scale items can be answered as true or false, and participants receive one point for each item they answer correctly. The scores that can be obtained from the scale vary between 0 and 30. An increase in the score obtained from the scale indicates that the level of knowledge is high. While the difficulty index values of the scale items ranged between 0.24 and 0.75, the discrimination index was calculated above 0.10. The test-retest reliability calculated to evaluate the reliability of the scale was found to be 0.81, and the Kuder-Richardson 20 coefficient was found to be 0.74.
Measured: In the pre-test of the research, the "Alzheimer's Disease Knowledge Scale" will be administered to the caregivers by the researcher, and the "Alzheimer's Disease Knowledge Scale" will be administered again 1 month later.
Dementia Attitude Scale
The scale was developed by O'Connor and McFadden in 2010 and translated into Turkish by Çetinkaya et al. Adapted from (2020). The scale was used with university students and direct care workers. During the creation of the scale, the expression "Alzheimer's disease and related diseases" was used in the scale expressions due to the terminological confusion between Alzheimer's Disease and Dementia. The scale is a 7-point Likert type, from 1 (strongly disagree) to 7 (strongly agree). 6 items of the scale, which consists of a total of 20 items, are reverse scored (2,6,8,9,16,17). As the score obtained from the scale increases, supportive and accepting attitudes increase, while exclusionary attitudes decrease. Cronbach's alpha value of the scale was found to be 0.83.
Measured: In the pre-test of the research, the "Dementia Attitude Scale" will be administered to the caregivers by the researcher, and the "Dementia Attitude Scale" will be administered again 1 month later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Gok Ugur, Ordu University
- Investigators
- Hacer GÖK Uğur, Asoss.Prof., Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182930
- Sponsor's protocol ID
- Ordu123456
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Caregivers of Alzheimer's Patients Registered With Home Health Services on Their Knowledge and Attitudes Towards Alzheimer's Disease: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06182930
- Acronym / sponsor ID
- Ordu123456
- Conditions
- Education
- Keywords
- Alzheimer, Caregiver, Knowledge, Attitude, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 27 Dec 2023 (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.
Purpose of the Research: This study will be conducted to determine the effect of the education given to caregivers of Alzheimer's patients registered to home health services on their knowledge and attitudes towards Alzheimer's disease.
Hypotheses of the Research H01: The education given to caregivers of Alzheimer's patients registered to home health services does not affect the caregivers' level of knowledge about Alzheimer's disease.
H11: The education given to caregivers of Alzheimer's patients registered to home health services increases the caregivers' level of knowledge about Alzheimer's disease.
H02: The education given to caregivers of Alzheimer's patients registered to home health services does not affect the caregivers' attitudes towards Alzheimer's disease.
H12: The education given to caregivers of Alzheimer's patients registered to home health services positively affects the caregivers' attitudes towards Alzheimer's disease.
Detailed description
-The number of elderly population is increasing in the world and in Turkey. Dementia increases with age. The most common type of dementia is Alzheimer's disease. As the Alzheimer's disease stage progresses, patients' dependency level in daily living activities increases and they need care support. Alzheimer's patients are usually cared for at home by family members. Caregivers may experience many difficulties in the home environment due to lack of knowledge in disease management. This study will be conducted to determine the effect of the education given to caregivers of Alzheimer's patients registered to home health services on their knowledge and attitudes towards Alzheimer's disease. The research was planned as a single-blind randomized controlled experimental study. The research will be conducted on caregivers of Alzheimer's patients registered to Giresun Province Bulancak State Hospital Home Health Services between 20 December 2023 and 20 December 2024. The population of the research will be the caregivers of Alzheimer's patients registered to Giresun Province Bulancak State Hospital Home Health Services. The sample of the research will be the caregivers of 60 patients who meet the research criteria and agree to participate in the research. The data of the study will be collected with the "Patient and Caregiver Introduction Form", "Alzheimer's Disease Information Scale" and "Dementia Attitude Scale". Necessary institutional permissions and ethics committee approval will be obtained for the research. In the research, caregivers in the experimental group will be trained about Alzheimer's disease in 2 sessions, 15 days apart, in the training hall of the hospital. No intervention will be applied to caregivers in the control group during the research. Necessary institutional permission and ethics committee approval will be obtained for the research. The analysis of the data will be done in a computer environment by an expert statistician.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Within the scope of the research, caregivers will be given face-to-face training in 2 sessions, 15 days apart.Within the scope of the research, caregivers will be given face-to-face training in 2 sessions, 15 days apart. |
| Control | No intervention | –They will receive routine home health care follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Those who are primarily responsible for the care of the patient diagnosed with Alzheimer's disease,
- Caring for a patient diagnosed with Alzheimer's disease for at least 6 months,
- Ages 18 and over,
- The one who is literate,
- Open to communication and collaboration,
Key exclusion criteria (3 listed)
- Cannot understand and speak Turkish,
- Those with mental and cognitive retardation and
- Caregivers who do not want to continue the research will be excluded from the research.
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 |
|---|---|---|
| Within the scope of the research, caregivers will be given face-to-face training in 2 sessions, 15 days apart.Also: No InterventionThey will receive routine home health care follow-up. | Other | Experimental |
Primary outcome
Alzheimer's Disease Knowledge Scale
Time frame: In the pre-test of the research, the "Alzheimer's Disease Knowledge Scale" will be administered to the caregivers by the researcher, and the "Alzheimer's Disease Knowledge Scale" will be administered again 1 month later.
The scale developed by Carpenter et al. (2009) was adapted to Turkish by Yılmaz and Çolak (2020). The scale consists of 30 items and evaluates people's level of knowledge about Alzheimer's disease. Scale items can be answered as true or false, and participants receive one point for each item they answer correctly. The scores that can be obtained from the scale vary between 0 and 30. An increase in the score obtained from the scale indicates that the level of knowledge is high. While the difficulty index values of the scale items ranged between 0.24 and 0.75, the discrimination index was calculated above 0.10. The test-retest reliability calculated to evaluate the reliability of the scale was found to be 0.81, and the Kuder-Richardson 20 coefficient was found to be 0.74.
Dementia Attitude Scale
Time frame: In the pre-test of the research, the "Dementia Attitude Scale" will be administered to the caregivers by the researcher, and the "Dementia Attitude Scale" will be administered again 1 month later.
The scale was developed by O'Connor and McFadden in 2010 and translated into Turkish by Çetinkaya et al. Adapted from (2020). The scale was used with university students and direct care workers. During the creation of the scale, the expression "Alzheimer's disease and related diseases" was used in the scale expressions due to the terminological confusion between Alzheimer's Disease and Dementia. The scale is a 7-point Likert type, from 1 (strongly disagree) to 7 (strongly agree). 6 items of the scale, which consists of a total of 20 items, are reverse scored (2,6,8,9,16,17). As the score obtained from the scale increases, supportive and accepting attitudes increase, while exclusionary attitudes decrease. Cronbach's alpha value of the scale was found to be 0.83.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- 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. This study is not recruiting at the moment.
Hacer GÖK Uğur, Asoss.Prof. principal investigator
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Within the scope of the research, caregivers will be given face-to-face training in 2 sessions, 15 days apart. in people with Education, run by Ordu 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 6 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hacer GÖK UĞUR, Asoss.Prof. (04522265200 ext. 6432, hacer32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Knowledge Scale (time frame: In the pre-test of the research, the "Alzheimer's Disease Knowledge Scale" will be administered to the caregivers by the researcher, and the "Alzheimer's Disease Knowledge Scale" will be administered again 1 month later.). 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 27 Dec 2023.