NCT07053553

Brief Summary

This study was conducted to determine the effects of home care training given to caregivers of patients receiving home care services on the anxiety and depression levels of the caregivers. The study was conducted as a pre-test/post-test, randomized controlled quasi-experimental with a total of 42 patients and caregivers receiving home care services, 21 in the experimental group and 21 in the control group, registered at the Home Health Unit of Kelkit District State Hospital in Gümüşhane province between September 2023 and December 2024. Caregiver Information Form, Beck Anxiety Inventory, Beck Depression Inventory, and Patient Body Bath Caregiver Follow-up Form were used as data collection tools. The caregivers in the experimental group were asked about which subject they wanted to receive training, and it was determined that they wanted to receive training on in-bed body bath, and patient body bath caregiver training was planned and implemented. No application was made to the caregivers in the control group. SPSS 22 statistical program was used in the analysis of the data and the significance level was accepted as p\<0.05.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
Last Updated

July 8, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

June 18, 2025

Last Update Submit

June 26, 2025

Conditions

Keywords

CaregiversHealth EducationHome CareHome NursingMental Health

Outcome Measures

Primary Outcomes (2)

  • Home care training has an effect on anxiety and depression levels of caregivers.

    Beck Anxiety Inventory is a self-assessment scale. It is a Likert-type scale consisting of 21 items. According to the scale score ranges, 0-7 points indicate minimal anxiety, 8-15 points indicate mild anxiety, 16-25 points indicate moderate anxiety, and 26-63 points indicate severe anxiety. The Beck Depression Inventory was developed by Beck in 1961 to measure the risk of depression in adults, the level of depressive symptoms, and the change in severity. The scale consists of 21 items. It is a four-degree self-assessment scale. The highest score that can be obtained from the scale is 63. The cut-off score was accepted as 17. According to the scale score ranges, 0-9 points indicate minimal depressive symptoms, 10-16 points indicate mild depressive symptoms, 17-29 points indicate moderate depressive symptoms, and 30 and above points indicate severe depressive symptoms.

    from registration to the end of the 12th week

  • Home care training has an impact on hospital admissions of patients receiving home care services.

    It is aimed to reduce the frequency of patients' hospital admissions after home care training.

    from registration to the end of the 12th week

Secondary Outcomes (1)

  • Home care training has an impact on the frequency of home care patients applying to the home care unit.

    from registration to the end of the 12th week

Study Arms (2)

Experimental (n=21)

EXPERIMENTAL

Experimental (n=21)

Other: Education

control groups

NO INTERVENTION

control (n=21) groups

Interventions

It was planned to provide bed bath training to inpatients because 90.5% of the caregivers of the patients in the experimental group wanted to receive bed bath training.

Experimental (n=21)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being registered with the Kelkit District State Hospital Home Health Unit
  • Being willing to participate in the research
  • Being able to read and write in Turkish and be able to communicate
  • Not having vision or hearing loss
  • Being able to make phone calls

You may not qualify if:

  • Not registered with Kelkit District State Hospital Home Health Unit
  • Not volunteering to participate in the research
  • Not knowing how to read and write in Turkish and not being able to communicate
  • Having vision and hearing loss
  • Not being able to communicate by phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gümüşhane University

Gümüşhane, Gümüşhane Province, 29600, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Health EducationPsychological Well-Being

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Havva Karadeniz, Assist.Prof.PhD

    Gümüşhane Universıty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 18, 2025

First Posted

July 8, 2025

Study Start

September 2, 2023

Primary Completion

December 30, 2024

Study Completion

April 25, 2025

Last Updated

July 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

all collected IPD, all IPD that underlie results in a publication

Shared Documents
SAP, ICF, CSR
Time Frame
September 2024- July 2025

Locations