NCT05542472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

September 13, 2022

Last Update Submit

September 14, 2022

Conditions

Keywords

caregivercase managementnurse-led

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • assessment of caregivers' quality of life

    6 months

Other Outcomes (1)

  • determination of family functional status

    6 months

Study Arms (2)

Control group

NO INTERVENTION

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

Interventional group

EXPERIMENTAL

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

Interventions

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.

Interventional group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Caregivers who did not give consent at any stage of the study and left.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University of Applied Sciences

Sakarya, 54000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Yurdanur Dikmen, Prof. Dr.

    Sakarya University of Applied Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 15, 2022

Study Start

March 11, 2020

Primary Completion

November 30, 2020

Study Completion

August 2, 2021

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations