NCT07313046

Brief Summary

Pressure ulcers are a significant health problem commonly seen in home care patients who are bedridden or have limited mobility, negatively affecting their quality of life. The knowledge and skills of caregivers play a crucial role in preventing these ulcers. This study aims to examine whether training provided to caregivers of patients receiving home care reduces the risk of pressure ulcer formation. As part of the study, caregivers will receive training on pressure ulcer risk factors, skin care, repositioning, pressure protection methods, and appropriate care practices. The pressure ulcer risk levels of patients will be assessed before and after the training, and the effect of the training will be compared. The results are expected to contribute to the development of caregiver training in home care services and the prevention of pressure ulcers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

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

July 12, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

December 17, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

pressure ulcer, prevention, home care, caregiver training

Outcome Measures

Primary Outcomes (2)

  • Pressure Ulcer Risk Level

    The pressure ulcer risk level of home care patients will be assessed before and after the caregiver training using a validated pressure ulcer risk assessment tool.

    Baseline and 4 weeks after training

  • Pressure Ulcer Risk Level

    The risk level of pressure ulcer development in patients receiving home care services will be measured using a valid risk assessment tool before and after the training provided to caregivers.

    Baseline and 3 weeks after training

Study Arms (1)

Caregiver Training Intervention

EXPERIMENTAL

In this section, a structured training program aimed at preventing pressure ulcers will be implemented for individuals providing care to patients receiving home care services. The training program covers pressure ulcer risk factors, skin assessment, repositioning techniques, care approaches to reduce pressure, and basic skin care. The training aims to improve caregivers' knowledge and care practices.

Behavioral: Caregiver Training Program

Interventions

A structured education program for caregivers about pressure ulcer risk factors, skin care, repositioning, and care practices for pressure reduction.

Caregiver Training Intervention

Eligibility Criteria

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

You may qualify if:

  • The study includes:
  • Patients registered with the Home Care Health Unit,
  • Volunteers willing to participate in the study,
  • Caregivers of patients classified as high or medium risk according to the Braden Risk Assessment Scale,
  • Caring for a patient who is not cared for by different individuals,
  • Aged 18 years or older,
  • Able to speak Turkish,
  • Without speech or hearing problems,
  • Cognitive competence sufficient to understand and answer questions.

You may not qualify if:

  • Not registered with the Home Care Health Unit,
  • Whose patient is classified as low risk according to the Braden Risk Assessment Scale,
  • Those with more than one caregiver,
  • Those who did not agree to participate in the study,
  • Those under the age of 18,
  • Those who did not speak Turkish,
  • Those with speech and hearing problems,
  • Caregivers who did not have the cognitive ability to understand and answer the questions were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın University

Bartın, Merkez, 74100, Turkey (Türkiye)

Location

Related Publications (1)

  • Afzali Borojeny L, Albatineh AN, Hasanpour Dehkordi A, Ghanei Gheshlagh R. The Incidence of Pressure Ulcers and its Associations in Different Wards of the Hospital: A Systematic Review and Meta-Analysis. Int J Prev Med. 2020 Oct 5;11:171. doi: 10.4103/ijpvm.IJPVM_182_19. eCollection 2020.

    PMID: 33312480BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Elif Karahan, PhD

    Bartın Unıversity

    STUDY DIRECTOR
  • Sevim ÇELİK, PhD

    Bartın Unıversity

    STUDY DIRECTOR
  • Sibel ALTINTAŞ, PhD

    Bartın Unıversity

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LEAD INVESTIGATOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

December 31, 2025

Study Start

July 12, 2024

Primary Completion

May 30, 2025

Study Completion

June 20, 2025

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy and confidentiality considerations.

Locations