The Effect of an Electronic Decision Support System on Preventing Pressure Ulcers and Urinary Infections in Home Care (CARE-UP)

September 5, 2026 updated by: Sebahat Gozum, Akdeniz University

The Effect of the Electronic Decision Support System Developed for the Use of Informal Caregivers on Preventing the Risk of Pressure Sore and Urinary Infection in Patients Receiving Home Care

This study evaluated Care-Up, a mobile-compatible web-based decision support system for informal caregivers of patients receiving home healthcare. The system provides guidance on skin care, pressure-injury prevention, urinary-risk indicators, nutrition, hydration and when to seek professional help.

The study had two stages: development and formative evaluation of Care-Up, followed by a parallel-group randomised controlled trial. In the trial, 66 patient-caregiver dyads were allocated equally to Care-Up plus routine home healthcare or routine home healthcare alone. Caregivers in the intervention group used Care-Up for eight weeks. Eligible patients were registered with the Burdur State Hospital Home Healthcare Services Unit and had a Barthel Index score of 0-20 or 21-61. There was no separate patient age restriction.

The registered primary outcome was pressure-injury risk assessed with the Braden Scale. Other assessments included skin integrity using GLOBIAD and ISTAP, urinalysis, urine colour and nutritional status. Nutritional status was assessed using the Mini Nutritional Assessment-Short Form (MNA-SF). Caregivers in the intervention group completed assessments of system usability, mobile-application usability, willingness to use the application and loyalty to the application at the end of the intervention.

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.
66

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.

Study Contact Backup

  • Name: Yusuf Güver, PhDc

Study Locations

  • Turkey (Türkiye)
      • Burdur, Turkey (Türkiye)
        • Burdur State Hospital Home Healthcare Services Unit

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients registered with and receiving care from the Burdur State Hospital Home Healthcare Services Unit. Service registration required age 65 years or older or being bedridden. The study imposed no additional patient age restriction.
  2. Patients with a Barthel Index total score of 0-20 (fully dependent) or 21-61 (severely dependent).
  3. An informal caregiver providing care at home who could use a mobile device and the Care-Up web-based system.
  4. Caregivers with an Adult Digital Literacy Scale score of at least 61 on the standardised 0-100 scale.
  5. Caregivers who were literate in Turkish and voluntarily agreed to participate.

Exclusion Criteria:

  1. Patients with a Barthel Index score of 62 or above.
  2. Patients with an acute medical condition, such as an infection requiring hospitalisation or a newly developed severe illness.
  3. Caregivers with cognitive or technological limitations preventing use of Care-Up, including lack of access to the required technology.
  4. Caregivers who were not literate in Turkish.
  5. Patients with terminal illness and a short life expectancy.
  6. Caregivers with severe cognitive impairment or an untreated psychiatric disorder affecting participation.
  7. Patients without an informal caregiver at home.
  8. Patients with an existing urinary infection identified from hospital records at baseline.
  9. Patients with an existing pressure injury at baseline.

Post-enrolment discontinuation criteria described in the study methods:

  • Patient-caregiver dyads moving outside the province.
  • Hospitalisation lasting more than one month after the study began.
  • Inability to complete the remaining study procedures after baseline assessments.

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: 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.
Experimental: Care-Up Electronic Decision Support System
Caregivers allocated to the intervention group received an initial demonstration of registration, password-protected access and use of the Care-Up electronic decision support system. They used the mobile-compatible web system for eight weeks. Care-Up provided structured assessments and personalised recommendations concerning pressure-injury risk, skin integrity, repositioning and in-bed mobility, nutrition and hydration, urinary-risk indicators, hygiene and catheter care, and recognition of findings requiring professional evaluation. The system also provided educational materials and red-flag guidance. Care-Up supported caregiver decision-making but did not diagnose disease or replace nursing or medical assessment.
Other: Care-Up Electronic Decision Support System
Eight weeks of access to a mobile-compatible web-based electronic decision support system, following initial training in registration and use. Care-Up provided structured risk assessments, educational materials, personalised recommendations and alerts concerning pressure-injury prevention, skin integrity, urinary-risk indicators, nutrition and hydration, positioning and in-bed mobility, and recognition of findings requiring professional evaluation. The system supported informal caregivers in addition to routine home healthcare.
No Intervention: Routine Home Healthcare
Participants allocated to the control group continued to receive routine home healthcare services, including usual assessment, monitoring, treatment, care and referral procedures. They did not receive access to Care-Up or Care-Up-specific digital recommendations, alerts or reminders during the study.

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
Pressure-Injury Risk
Time Frame: Baseline, 5th and 9th weeks
Change in the Braden Scale for Predicting Pressure Sore Risk total score. Total scores range from 6 to 23, with higher scores indicating lower pressure-injury risk.
Baseline, 5th and 9th weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nutritional Status
Time Frame: Baseline, 5th and 9th weeks
Nutritional status was assessed using the Mini Nutritional Assessment-Short Form (MNA-SF). Change in the MNA-SF total score was evaluated. Scores range from 0 to 14, with higher scores indicating better nutritional status.
Baseline, 5th and 9th weeks
Urinary Infection Risk Indicators
Time Frame: Baseline, 5th and 9th weeks
Change in urinalysis parameters used to assess urinary infection risk, including leukocytes, nitrite, protein and blood. Urinalysis results were obtained from the patients' routine laboratory records. These laboratory indicators were evaluated as risk-related measures rather than as a culture-confirmed urinary tract infection endpoint.
Baseline, 5th and 9th weeks
Incontinence-Associated Dermatitis
Time Frame: Baseline, 5th and 9th weeks
Change in skin condition assessed using the Ghent Global Incontinence-Associated Dermatitis Categorisation Tool (GLOBIAD). The tool classifies persistent redness (category 1) and skin loss (category 2), with subcategories indicating the absence (A) or presence (B) of clinical signs of infection. Category 2 indicates more severe skin damage than category 1.
Baseline, 5th and 9th weeks
Skin Tears
Time Frame: Baseline, 5th and 9th weeks
Change in skin-tear classification assessed using the International Skin Tear Advisory Panel (ISTAP) Skin Tear Classification System. Skin tears are classified as type 1 (no skin loss), type 2 (partial flap loss) or type 3 (total flap loss); higher types indicate more extensive skin loss.
Baseline, 5th and 9th weeks
Urine Colour
Time Frame: Baseline, 5th and 9th weeks
Change in urine colour assessed using the Armstrong Urine Colour Chart. Scores range from 1 to 8, with higher scores indicating darker, more concentrated urine. Urine samples were visually compared with the colour chart under standard lighting.
Baseline, 5th and 9th weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
System Usability
Time Frame: At the end of the eight-week intervention (9th week assessment)
Perceived usability of Care-Up assessed among intervention-group caregivers using the Turkish version of the System Usability Scale (SUS-TR). The ten-item scale yields a total score from 0 to 100; higher scores indicate better perceived system usability.
At the end of the eight-week intervention (9th week assessment)
Mobile Application Usability
Time Frame: At the end of the eight-week intervention (9th week assessment)
Perceived mobile-application usability assessed among intervention-group caregivers using the Turkish Mobile Application Usability Scale. Mean item scores range from 1 to 7, with higher scores indicating greater perceived usability.
At the end of the eight-week intervention (9th week assessment)
Willingness to Use the Mobile Application
Time Frame: At the end of the eight-week intervention (9th week assessment)
Willingness to continue using Care-Up assessed among intervention-group caregivers using the Turkish Mobile Application Willingness to Use Scale. Mean item scores range from 1 to 7, with higher scores indicating greater willingness to continue using the application.
At the end of the eight-week intervention (9th week assessment)
Mobile Application Loyalty
Time Frame: At the end of the eight-week intervention (9th week assessment)
Loyalty to Care-Up assessed among intervention-group caregivers using the Turkish Mobile Application Loyalty Scale. Mean item scores range from 1 to 7, with higher scores indicating greater loyalty to the application.
At the end of the eight-week intervention (9th week assessment)

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.
Akdeniz 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.
February 23, 2026

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.
April 20, 2026

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.
April 20, 2026

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).
March 20, 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.
April 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.
April 15, 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 10, 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 5, 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

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.
  • TBAEK-257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Aggregate analysis results will be disseminated in publications derived from the thesis. A definitive plan for sharing individual participant data has not been established. If a journal requests data with an appropriate justification during submission or review of a thesis-derived manuscript, sharing of de-identified data may be considered on a case-by-case basis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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