Pressure InjuryNCT06848049
Mobile Application-Assisted Pressure Injury Management
A study testing Mobile Aplication in people with Pressure Injury and Nursing Caries, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury, Nursing Caries, Application Site Wound
- What is being tested?
- Mobile Aplication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pressure Injury, Nursing Caries, Application Site Wound
- Being tested
- Mobile Aplication, Control
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile AplicationOther
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Aplication | Experimental | Not described Receives: Other: Mobile Aplication |
| Control | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Jun 2025
- Primary completion30 Aug 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Kokkiz, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848049
- Sponsor's protocol ID
- 02.2025fbu
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobile Application-Assisted Nursing Services on Pressure Injury Management: A Randomized Controlled Trial on Patients Receiving Home Care
- ClinicalTrials.gov ID
- NCT06848049
- Acronym / sponsor ID
- 02.2025fbu
- Conditions
- Pressure Injury, Nursing Caries, Application Site Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Aplication | Experimental | Other: Mobile Aplication |
| Control | Active comparator | Other: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile AplicationIn 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. | Other | Mobile Aplication |
| ControlIn 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. | Other | Control |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Aplication in people with Pressure Injury and Nursing Caries, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.