Clinical trial NCT06927479: The Effect of an Electronic Decision Support System on Preventing Pressure Ulcers and Urinary Infectionsin Home Care
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Controlled Study
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Prevention of Pressure Ulcer Risk
timeFrame: Baseline, 5th and 9th weeks
Secondary outcomes:
measure: Nutritional and Hydration Status
timeFrame: Baseline, 5th and 9th weeks
measure: Prevention of Urinary Infection Risk
timeFrame: Baseline, 5th and 9th weeks.
Other outcomes:
Locations:
Study officials:
References: