Mobile Application-Assisted Pressure Injury Management

September 3, 2026 updated by: Rukiye Kokkiz, Fenerbahce University

Effect of Mobile Application-Assisted Nursing Services on Pressure Injury Management: A Randomized Controlled Trial on Patients Receiving Home Care

Pressure injuries develop due to decreased movement, especially in bedridden individuals receiving home care. In Turkey, the management of pressure injuries is carried out by nurses in acute and long-term care settings, and mostly by caregivers for individuals receiving home care. Studies have shown that individuals providing home care have a significant need for training. Today, digital health technologies are used to facilitate access to healthcare professionals and provide workload and cost efficiency. Telehealth services in these technologies can be provided via telephone or mobile applications. In this context, the aim of the study is to examine the effect of nursing services provided via mobile applications on the management of pressure injuries in individuals receiving home care. The study was designed as a randomized controlled experimental type. In the power analysis conducted to calculate the sample size, the sample size was determined as 56, and considering that there may be data losses, 60 people will be included in the study. The "Structured Information Form, Pressure Injury Information Form for Caregivers, Pressure Injury Skill Checklist for Caregivers, and Pressure Injury Follow-up Form" will be used as data collection tools in the study. In this study, it is thought that the nurse's remote monitoring of individuals receiving home care with a mobile application in the management of pressure injuries will contribute to patient safety and care costs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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 (Actual)

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.
30

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 Locations

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:

  • Individuals receiving home care and caregivers
  • Individuals over the age of 18
  • Individuals with a caregiver who can use the mobile application (The mobile application will be introduced to the caregivers in the first meeting and consent will be obtained from the individual to use it)
  • Individuals with a smartphone
  • Individuals who can use a smartphone
  • Individuals who fill in the data completely
  • Individuals with a pressure injury

Exclusion Criteria:

  • Individuals who cannot use mobile applications
  • Individuals who cannot use smartphones
  • Individuals who want to leave the study
  • Individuals who have incomplete data collected in the study for various reasons
  • Individuals with chronic diseases (Diabetes and Hypertension)

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover 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.
Active Comparator: Control
Other: Control
In this study, individuals will be monitored for 28 days. In order to monitor their knowledge about pressure injuries, individuals will be asked to complete the Pressure Injury Information Form for Caregivers and the Pressure Injury Skills Checklist to monitor their skill levels about pressure injuries throughout the study period. The Bates-Jensen Wound Assessment Tool will be completed by the researcher to perform a physical examination of the patient and to assess the healing of the individual's pressure injury. Individuals in the control group will be interviewed twice by phone. Individuals with pressure injuries will be trained by a team consisting of a physician, nurse, dietician, and physiotherapist. Individuals will be interviewed twice by phone. After 30 days, individuals will be asked to complete the Mobile Health Application Acceptance Scale, the Pressure Injury Knowledge Scale for Caregivers, and the Pressure Injury Skills Checklist.
Experimental: Mobile Aplication
Other: Mobile Aplication
In this study, individuals will be monitored for 28 days. They will be asked to fill out the Pressure Injury Information Form and the Pressure Injury Skills Checklist for Caregivers to be informed about pressures throughout the study process. The researcher will fill out the Bates-Jensen Wound Assessment Tool to ensure that their pressures are improving. Individuals who will undergo the intervention will use the mobile application. Face-to-face training will be provided to individuals. Individual-specific audio reminders will be based on daily living activities and will be delivered via the mobile application according to changes in individual dependencies. After 30 days, individuals will be asked to fill out the Mobile Health Application Acceptance Scale, the Pressure Injury Knowledge Scale for Caregivers, and the Pressure Injury Skills Checklist. The Bates-Jensen Wound Assessment Tool will be filled out by the researcher.

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
Improvement (decrease) in the Bates-Jensen Wound Assessment Tool scores of individuals receiving nursing services will be observed with the mobile application developed for the management of pressure injuries.
Time Frame: 28 days
The assessment tool developed by Bates-Jensen et al. in 1992 is a scale that broadly addresses the physiological and anatomical characteristics of the wound. It consists of 13 items: size, depth, edges, tunneling, type and amount of necrotic tissue, type and amount of exudate, color of the skin around the wound, peripheral tissue edema and induration, granulation tissue and epithelialization. As a result of the scale scoring, 1 point indicates that the wound is in better condition, while 5 points indicate that the wound condition is worse. In the presence of necrotic tissue, the type and amount of necrosis are also included in the assessment. The total score obtained varies between 13-65, and an increase in the score indicates that the wound condition is worsening.
28 days
Improvement (increase) will be observed in the "Pressure Injury Knowledge Scale for Caregivers" scores of caregivers receiving nursing services through the mobile application developed for the management of pressure injuries.
Time Frame: 28 days
The Pressure Injury Patient Information Form was prepared by the researcher in line with the literature. There are questions about the management of pressure injuries. The form consists of 15 questions. Each question is 1 point, the lowest score is "0" and the highest score is "15". As the score increases, the knowledge of individuals to manage pressure injuries increases. Before starting the research, expert opinions will be presented and arrangements will be made.
28 days
Improvement (increase) will be observed in the "Pressure Injury Skills Checklist" scores of caregivers receiving nursing services through the mobile application developed for the management of pressure injuries.
Time Frame: 28 days
The Pressure Injury Skill Form was prepared by the researcher in line with the literature. The form consists of 10 items. For each item, "Not Applied" was evaluated as "0" points, "Partially Applied" as "1" points, and "Applied" as "2" points. The lowest score to be received from the checklist is "0" and the highest score is "20". An increase in the score indicates that the individual's pressure injury skills have improved. Before starting the research, it will be presented to expert opinions and arrangements will be made.
28 days

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.
Fenerbahce University

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 (Actual)

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.
June 1, 2025

Primary Completion (Actual)

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.
August 30, 2025

Study Completion (Actual)

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.
October 30, 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).
February 21, 2025

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 21, 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.
February 26, 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.
September 4, 2026

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.
September 3, 2026

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.
September 1, 2026

More Information

Terms related to this study

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.
  • 02.2025fbu

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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