The Effect of Web-Based Training and Counseling Given to Caregivers on the Pressure Injury Risk, Level of Dependence-Independence, and Caregivers' Burden of Care in Bedridden Patients

February 14, 2025 updated by: Şerife Kelle Dikbaş, Istanbul University - Cerrahpasa
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To prevent pressure injuries; It has been determined that there are a limited number of studies in which training, telephone monitoring and counseling are provided to caregivers The originality of this study, which was conducted to evaluate the effect of web-based training given to caregivers on the pressure injury development of bedridden patients, addiction independence level and care burden of caregivers; The training is designed as web-based and creates a guide that caregivers can use during the care process.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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,

Exclusion Criteria:

The patient;

  • Having cancer,
  • Having an active skin disease,
  • Blood glucose and blood pressure are not under control,
  • Use of medication that may be associated with pressure injury (corticosteroid, immunosuppressive, sedative medication, antineoplastic medication, norepinephrine) is an exclusion criterion from the study.

Criteria for Exclusion from the Study The patient;

  • The patient is hospitalized,
  • The patient's exitus is a criterion for exclusion from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: interventions to be applied to the experimental group (web-based training and consultancy )
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
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.
Other: interventions to be applied to the control group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Findings regarding sociodemographic characteristics
Time Frame: 8 weeks, "up to two months".

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
Time Frame: 8 weeks, "up to two months".
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
Time Frame: 8 weeks, "up to two months".
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
Time Frame: 8 weeks, "up to two months".
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".

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • interventation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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