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Completed

NCT Number: NCT06927479

The Effect of an Electronic Decision Support System on Preventing Pressure Ulcers and Urinary Infections in 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.

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Key information

Conditions

Support of the Family as a Caregiving System Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burdur State Hospital Home Healthcare Services Unit

Burdur, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients with a Barthel Index total score of 0-20 (fully dependent) or 21-61 (severely dependent).
  • An informal caregiver providing care at home who could use a mobile device and the Care-Up web-based system.
  • Caregivers with an Adult Digital Literacy Scale score of at least 61 on the standardised 0-100 scale.
  • Caregivers who were literate in Turkish and voluntarily agreed to participate.

Exclusion criteria

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

Treatment and study plan

Care-Up Electronic Decision Support System

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Acronym: CARE-UP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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