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The Effect on Caregivers of a Family Support Program

Primary Purpose

Caregiver Burnout

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Family Support Program Based on a Nurse-Led Case Management Model
Sponsored by
Sakarya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Caregiver Burnout focused on measuring caregiver, case management, nurse-led

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sakarya University of Applied Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Interventional group

Arm Description

No intervention will perform on the caregivers in the control group. The patients will continue to receive care under public services.

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

Outcomes

Primary Outcome Measures

Change in caregiver burden in 6 months
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.

Secondary Outcome Measures

assessment of caregivers' quality of life
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.

Full Information

First Posted
September 13, 2022
Last Updated
September 14, 2022
Sponsor
Sakarya University
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1. Study Identification

Unique Protocol Identification Number
NCT05542472
Brief Title
The Effect on Caregivers of a Family Support Program
Official Title
The Effect on Caregivers of a Family Support Program Based on a Nurse-Led Case Management Model
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
August 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sakarya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of a family support program based on the nurse-led case management model on individuals providing care for patients who are confined to bed at home.
Detailed Description
It is of paramount importance to enable the patients receiving home care and their relatives to adapt social life, to fulfil their social integration, to relieve the burden of family members of the individual in need of care, especially the individual providing care, by supporting them in the environment where they live. In this study, it is aimed to investigate the effect of the family support program based on the nurse-led case management model for family members who care for bedridden patients.The family support program based on a five-stage nurse-led case management model is administered for the caregivers in the intervention group, the caregivers in the control group is monitored by home health services through routine follow-ups. The research will conducted as a randomized controlled study with an experimental design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burnout
Keywords
caregiver, case management, nurse-led

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention will perform on the caregivers in the control group. The patients will continue to receive care under public services.
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Family Support Program Based on a Nurse-Led Case Management Model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in caregiver burden in 6 months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
assessment of caregivers' quality of life
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
determination of family functional status
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yurdanur Dikmen, Prof. Dr.
Organizational Affiliation
Sakarya University of Applied Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Sakarya University of Applied Sciences
City
Sakarya
ZIP/Postal Code
54000
Country
Turkey

12. IPD Sharing Statement

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The Effect on Caregivers of a Family Support Program

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