- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05542472
The Effect on Caregivers of a Family Support Program
The Effect on Caregivers of a Family Support Program Based on a Nurse-Led Case Management Model
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Sakarya, Turkey, 54000
- Sakarya University of Applied Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Volunteering to participate in the study,
- To have been taking care of the caregiver for at least 6 months,
- Being literate
- Not to have sensory loss such as vision and hearing,
- Being open to communication and cooperation,
- Internet access and being able to use it,
- Having a phone where he can be reached,
- Not receiving any remuneration for the provision of care,
- Having a family bond with the person being cared for.
Exclusion Criteria:
- Caregivers who do not meet the inclusion criteria,
- Caregivers who did not give consent at any stage of the study and left.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
No intervention will perform on the caregivers in the control group.
The patients will continue to receive care under public services.
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Experimental: Interventional group
A Family Support Program Based on the Nurse-Led Case Management Model will create for the caregivers in the intervention group. The nurse-led case management model is made up of five basic nursing activities. First Nursing Activity: Determining individuals who can benefit from the case management model Second Nursing Activity: Establishing individuals' problems and care needs Third Nursing Activity: Planning nursing activities to meet the determined needs Fourth Nursing Activity: Implementing nursing activities Fifth Nursing Activity: Regular review, monitoring and assessment of nursing activities |
A Family Support Program Based on the Nurse-Led Case Management Model create for the care givers in the intervention group.
Case management is the process of planning an individual's care, coordinating it, managing it, implementing it and reviewing it.
The aim in case management is to improve a person's quality of life by coordinating health care services and providing these services at a reasonable cost and in a productive way.
The use of case management requires the cooperation of professionals from many different disciplines.
Therefore, in areas where case management is applied, the case manager coordinates an individual's or patient's care by enabling this cooperation.
In this way, in areas where health services are provided, the case manager may be a doctor, a nurse, a physiotherapist, a social services expert, or a speech therapist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in caregiver burden in 6 months
Time Frame: 6 months
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Zarit Caregiver Burden Scale: This scale was developed in 1980 by Zarit et al. to assess the stress experienced by those providing care to old people or to those in need of care.
The lowest possible score is 0 and the highest is 88.
A high score on the scale shows a high level of distress experienced.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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assessment of caregivers' quality of life
Time Frame: 6 months
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WHOQOL-BREF-TR Form: This form is the Turkish adaptation of the WHOQOL-100, which was developed by the World Health Organization to assess the quality of life of individuals.
Cultural adaptation of the WHOQOL-BREF-TR in Turkey and validity and reliability work were conducted by Eser et al. (1999).
This scale consists of 26 questions selected from the WHOQOL-BREF WHOQOL-100 scale.
One item was added to the Turkish version of the scale.
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6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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determination of family functional status
Time Frame: 6 months
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Family APGAR Scale: This scale, which evaluates the perceptions of family members concerning their functionality among themselves is used in determining the weak areas in family functions in a short time.
The scale was developed by Smilkstein (1978) and adapted to Turkish in 2011 (Özcan et al. 2011).
The Family APGAR Scale measures the five parameters of family functionality in adults of adaptation, partnership, growth, affection and resolve.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yurdanur Dikmen, Prof. Dr., Sakarya University of Applied Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16214662/050.0104/127
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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