- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07672340
Care Burden And Qualıty of Lıfe (Care Burden)
Effect Of Multıdımensıonal Traınıng Applıed to Caregıvers of Home Health Servıce Recıpıents Aged 65 And Over on Care Burden And Qualıty of Lıfe
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dilek Hassoy
- Phone Number: +905054829071
- Email: dihassoy09@gmail.com
Study Contact Backup
- Name: Safiye Özvurmaz, professor
- Phone Number: +90 5374746531
- Email: sozvurmaz@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
• 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
The control group continued to receive the routine care
|
|
|
Experimental: Structured education
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Before intervention
|
|
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.
|
1 week after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Before intervention
Time Frame: 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.
|
Before intervention
|
|
After intervention
Time Frame: 1 week 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.
|
1 week after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10.01.2024-1389-1409
- HF-24005 (Other Grant/Funding Number: Aydın Adnan Menderes University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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