The Effect on Caregivers of a Family Support Program

September 14, 2022 updated by: fatma tanrıkulu, Sakarya University

The Effect on Caregivers of a Family Support Program Based on a Nurse-Led Case Management Model

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sakarya, Turkey, 54000
        • Sakarya University of Applied Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in caregiver burden in 6 months
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of caregivers' quality of life
Time Frame: 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.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
determination of family functional status
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2020

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

August 2, 2021

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 14, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 16214662/050.0104/127

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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