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NCT Number: NCT06927479

The Effect of an Electronic Decision Support System on Preventing Pressure Ulcers and Urinary Infectionsin Home Care

The home care of fully dependent patients is often provided by informal family caregivers. Therefore, caregivers need support systems to make the right decisions during home care to prevent pressure ulcers and urinary infections. This study aims to evaluate the impact of using an electronic decision support system (E-DSS), offered through a mobile-compatible webpage, on preventing the risk of pressure ulcers and urinary infections in fully dependent patients receiving home healthcare services.

The study is planned in two phases. In the first phase, the development of the electronic decision support system to be provided through a mobile-compatible webpage is targeted. In the second phase, a randomized controlled trial will be conducted to assess the usability of the developed decision support system by caregivers.

For the project, patients with a Barthel Index score between 0-20 (if an insufficient number of patients is available, those scoring between 21-61 will also be included) will be selected and divided into intervention and control groups. Caregivers of the intervention group will use the electronic decision support system via a mobile-compatible webpage for eight weeks to receive guidance on preventing pressure ulcers, urinary infection prevention strategies, in-bed mobilization, and nutrition recommendations. Caregivers in the control group will continue with the routine practices of the home healthcare services provided by the Turkish Ministry of Health.

The study outcomes will be evaluated at the beginning and at the ninth week using the Braden Pressure Ulcer Risk Scale, the Ghent Global IAD Classification Tool (GLOBIAD), the ISTAP Skin Tear Classification System, urinalysis (UA), the Urine Color Scale, and the Mini Nutritional Assessment-Short Form (MNA-SF). Additionally, at the end of the study, caregivers in the intervention group will be assessed using the System Usability Scale (SUS-TR), the Mobile Application Usability Scale, the Mobile Application Loyalty Scale, and the Mobile Application Willingness to Use Scale.

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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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients receiving home healthcare services.
  • Patients with a total Barthel Index score of 0-20 (fully dependent) and 21-61 (severely dependent).
  • Caregivers who are familiar with using mobile devices and voluntarily agree to participate.

Exclusion criteria

  • Patients with a Barthel Index score of 62 or above.
  • Patients with an acute medical condition (e.g., hospitalization due to infection or newly developed severe illness).
  • Caregivers with cognitive or technological limitations preventing
  • Caregivers who are not literate in Turkish and unable to use the application.
  • Terminal-stage patients* with a life expectancy of a short period.
  • Caregivers with severe cognitive impairment (e.g., advanced-stage dementia) or untreated psychiatric disorders (e.g., schizophrenia).
  • Patients without an informal caregiver providing care at home.
  • Patients with an existing urinary infection based on hospital urinalysis records.

Treatment and study plan

Training about Electronic Decision Support System

Other
  • System Registration and Usage
  • Pressure Ulcer Prevention
  • Urinary Infection Prevention
  • Nutrition and Hydration Management
  • Physical Activity and In-Bed Mobilization
  • Emergency Management and Reporting
  • Continuous Monitoring and Feedback

Primary outcomes

  1. Prevention of Pressure Ulcer Risk

    Time frame: Baseline, 5th and 9th weeks

    Change in pressure ulcer risk scores measured by the Braden Pressure Ulcer Risk Scale

Secondary outcomes

  1. Nutritional and Hydration Status

    Time frame: Baseline, 5th and 9th weeks

    This change will be evaluate by Mini Nutritional Assesment Short Form

  2. Prevention of Urinary Infection Risk

    Time frame: Baseline, 5th and 9th weeks.

    Change in urinary infection risk based on urinalysis (UA) results

Study contacts

Contact information is provided by the study sponsor or research team.

Sebahat Gözüm, Prof.Dr.

CONTACT

[email protected]

+9002423106916

Yusuf Güver, PhDc

CONTACT

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: e-CARE

Important dates

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

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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