The Effect on Caregivers of a Family Support Program

Sponsor
Sakarya University (Other)
Overall Status
Completed
CT.gov ID
NCT05542472
Collaborator
(none)
27
1
2
16.7
1.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Family Support Program Based on a Nurse-Led Case Management Model
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effect on Caregivers of a Family Support Program Based on a Nurse-Led Case Management Model
Actual Study Start Date :
Mar 11, 2020
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Aug 2, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

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

Other: Family Support Program Based on a Nurse-Led Case Management Model
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.

Outcome Measures

Primary Outcome Measures

  1. Change in caregiver burden in 6 months [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

  1. assessment of caregivers' quality of life [6 months]

    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.

Other Outcome Measures

  1. determination of family functional status [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sakarya University of Applied Sciences Sakarya Turkey 54000

Sponsors and Collaborators

  • Sakarya University

Investigators

  • Study Director: Yurdanur Dikmen, Prof. Dr., Sakarya University of Applied Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
fatma tanrıkulu, Principal Investigator, Sakarya University
ClinicalTrials.gov Identifier:
NCT05542472
Other Study ID Numbers:
  • 16214662/050.0104/127
First Posted:
Sep 15, 2022
Last Update Posted:
Sep 15, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by fatma tanrıkulu, Principal Investigator, Sakarya University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 15, 2022