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

NCT06927479 | Not Yet Recruiting

• 1 other identifier: TBAEK-257
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Support of the Family as a Caregiving System

Keywords

decision support system; pressure ulcer; urinary infection; home care; infection risk; dependent patients; informal caregiver

Outcome Measures

Primary Outcomes (1)

• Prevention of Pressure Ulcer Risk

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

  Baseline, 5th and 9th weeks

Secondary Outcomes (2)

• Nutritional and Hydration Status

  Baseline, 5th and 9th weeks

• Prevention of Urinary Infection Risk

  Baseline, 5th and 9th weeks.

Study Arms (2)

Intervention group

EXPERIMENTAL

Caregivers in this group will use the electronic decision support system (E-DSS) provided via a mobile-compatible web page. E-DSS will be used to optimize the daily care management of patients and to reduce the risk of pressure ulcers and the risks that predict this risk, such as nutrition and hydration, position changes and in-bed activities. E-DSS will analyze the data obtained from the participants and provide personalized recommendations. Caregivers in the intervention group will receive this training over a period of two weeks, with ongoing support and reinforcement provided throughout the eight-week intervention period via the Electronic Decision Support System (E-DSS).

Other: Training about Electronic Decision Support System

Control group

NO INTERVENTION

This group will contiue with home care services by Health Ministriy ot Turkiye

Interventions

Training about Electronic Decision Support System OTHER

1. System Registration and Usage 2. Pressure Ulcer Prevention 3. Urinary Infection Prevention 4. Nutrition and Hydration Management 5. Physical Activity and In-Bed Mobilization 6. Emergency Management and Reporting 7. Continuous Monitoring and Feedback

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

MeSH Terms

Conditions

Pressure Ulcer; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Sebahat Gözüm, Prof.Dr.

CONTACT

+9002423106916; sgozum@akdeniz.edu.tr

Yusuf Güver, PhDc

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: A Randomized Controlled Study

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 15, 2025
• Study Start: September 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-03