NCT06832345

Brief Summary

Education and counseling of patients and caregivers, either face-to-face or using various communication technologies, are reported to have significant effects. Nurses are in a key position in the education and counseling of patients and their relatives for the prevention of pressure injury. Although the share of health technologies in the management of pressure injury is important, it is also important for nurses to use these technologies. Web-based education, which is a part of health technologies, is defined as an education and training program created by using the features of internet and computer technologies.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 28, 2024

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

June 28, 2024

Last Update Submit

February 14, 2025

Conditions

Keywords

pressure injury prevention

Outcome Measures

Primary Outcomes (4)

  • Findings regarding sociodemographic characteristics

    Evaluation of data that may be related to pressure injuries for patients and caregivers. Data such as patient\'s age, height, weight, chronic diseases and data such as caregivers\' age, inclination, and caregiving duration will be evaluated as averages and percentages.

    8 weeks, "up to two months".

  • Evaluation of the results regarding the patient's level of dependency and independence

    According to the total scores of the Barthell Life Activities Index; 0-20 points: "Fully dependent", 21-61 points: "Extremely dependent", 62-90 points: "Moderately dependent", 91-99 points: "Mildly dependent" and 100 points: "Fully independent"

    8 weeks, "up to two months".

  • Assessment of patient's pressure injury risk score

    According to the braden pressure injury risk assessment scale: The total scale score is between 6 and 23. As the scores from the scale decrease, the risk of developing a pressure injury increases. Individuals with a scale score of 12 and below are considered to be at high risk for developing a pressure injury, those with a score of 13-14 are considered to be at medium risk, and those with a score of 15-16 are considered to be at low risk. According to the inclusion criteria for this study, patients must be assessed as high and medium risk according to the Braden pressure injury risk assessment scale.

    8 weeks, "up to two months".

  • Results regarding the caregiver's care burden

    According to the zarit caregiver burden scale: If the resulting score is between 22-46 points, it is defined as 'light load', if it is between 47-55 points, it is defined as 'moderate load', and if it is between 56-110 points, it is defined as 'severe load'.

    8 weeks, "up to two months".

Study Arms (2)

interventions to be applied to the experimental group (web-based training and consultancy )

OTHER

Web-based education and counseling services will be provided as an intervention. Web-based education will be provided to the caregiver in the patient's room in two face-to-face sessions within forty-eight hours before the patient is discharged. Counseling will include telephone follow-up and home visits after discharge. Telephone follow-up will be done once a week, for a total of 8 times, and home visits will be done 3 times over an 8-week period. The results will be assessed using the Braden Pressure Injury Risk Scale, Barthell Index, and data collection tools for patients in the experimental group, and the Zarit Caregiver Burden Scale will be used for caregivers.

Other: Experimental group

interventions to be applied to the control group

OTHER

Caregivers in the control group will receive routine nursing care and no intervention will be made. At the end of the study, the website and educational content will be shared with patients and their relatives.

Other: Experimental group

Interventions

Web-based training will be shared with patient relatives before the patient is discharged. A home visit will be made 2-3 days after the patient is discharged. Data collection forms will be collected by the researcher at each home visit. A total of four home visits and eight telephone follow-ups will be made within two months.

interventions to be applied to the control groupinterventions to be applied to the experimental group (web-based training and consultancy )

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient;
  • Being over 18 years of age
  • Being open to communication (Mini Mental Test Score \>25 points),
  • Medium or high risk according to the Braden pressure injury assessment scale (score ≤14 according to the Braden pressure injury risk assessment scale)
  • Being at least a moderately dependent patient according to the Barthel Index (score ≤90 according to the Barthel Index) The caregiver;
  • Being primarily responsible for patient care,
  • Being over 18 years of age
  • Having a family bond with the patient,
  • No monthly fee for providing care, (except for those receiving a monthly care pension from the state)
  • Lack of healthcare workers (physician, midwife, nurse),
  • Ability to read and write,
  • Having a smartphone and internet access,
  • Accepting a home visit,
  • There is no physical or psychiatric obstacle that prevents communication,

You may not qualify if:

  • The patient;
  • Having cancer,
  • Having an active skin disease,
  • Blood glucose and blood pressure are not under control,
  • The patient is hospitalized,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Serife KELLE DIKBAS, Lecturer

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 28, 2024

First Posted

February 18, 2025

Study Start

March 1, 2025

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share