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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05542472
Other study ID # 16214662/050.0104/127
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 11, 2020
Est. completion date August 2, 2021

Study information

Verified date September 2022
Source Sakarya University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date August 2, 2021
Est. primary completion date November 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Sakarya University of Applied Sciences Sakarya

Sponsors (1)

Lead Sponsor Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other determination of family functional status 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
Primary 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. 6 months
Secondary 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. 6 months
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