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

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: Completed
• Conditions: Support of the Family as a Caregiving System
• Intervention / Treatment: Other: Care-Up Electronic Decision Support System

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Pressure-Injury Risk	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

Outcome Measure	Measure Description	Time Frame
Nutritional Status	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
System Usability	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	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	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	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

• Sponsor: Akdeniz University

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2026
• Primary Completion (Actual): April 20, 2026
• Study Completion (Actual): April 20, 2026

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 5, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: informal caregiver; home care; urinary infection; pressure ulcer; decision support system; infection risk; dependent patients
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Skin Diseases; Skin Ulcer; Skin and Connective Tissue Diseases; Urinary Tract Infections; Pressure Ulcer
• Other Study ID 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