Support of the Family as a Caregiving SystemCARE-UPNCT06927479
The Effect of an Electronic Decision Support System on Preventing Pressure Ulcers and Urinary Infections in Home Care
A study testing Care-Up Electronic Decision Support System in people with Support of the Family as a Caregiving System, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Support of the Family as a Caregiving System
- What is being tested?
- Care-Up Electronic Decision Support System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2026to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Burdur State Hospital Home Healthcare Services Unit
Burdur
About this study
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
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.
- Being tested
- Care-Up Electronic Decision Support System
- Keywords
- decision support system, pressure ulcer, urinary infection, home care, infection risk, dependent patients, informal caregiver
- Medical subject headings
- Pressure Ulcer, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care-Up Electronic Decision Support SystemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Care-Up Electronic Decision Support System | Experimental | 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. Receives: Other: Care-Up Electronic Decision Support System |
| Routine Home Healthcare | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 5th and 9th weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 5th and 9th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start23 Feb 2026
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Support of the Family as a Caregiving SystemStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient-caregiver dyads were allocated in a 1:1 ratio using stratified block randomisation. Stratification was based on Barthel Index dependency category: 0-20, fully dependent; and 21-61, severely dependent. Eleven blocks of six were generated using the mobile application 'Statistics and Sample Size' by a researcher who had no contact with patients or caregivers. Dyads were numbered consecutively, and allocation was implemented using numbered opaque envelopes.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebahat Gozum, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927479
- Sponsor's protocol ID
- TBAEK-257
- Acronym
- CARE-UP
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06927479
- Acronym / sponsor ID
- CARE-UP / TBAEK-257
- Keywords
- decision support system, pressure ulcer, urinary infection, home care, infection risk, dependent patients, informal caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patient-caregiver dyads were allocated in a 1:1 ratio using stratified block randomisation. Stratification was based on Barthel Index dependency category: 0-20, fully dependent; and 21-61, severely dependent. Eleven blocks of six were generated using the mobile application 'Statistics and Sample Size' by a researcher who had no contact with patients or caregivers. Dyads were numbered consecutively, and allocation was implemented using numbered opaque envelopes.
| Arm | Type | Receives |
|---|---|---|
| Care-Up Electronic Decision Support System | Experimental | Other: Care-Up Electronic Decision Support SystemCaregivers 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. |
| Routine Home Healthcare | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care-Up Electronic Decision Support SystemEight 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. | Other | Care-Up Electronic Decision Support System |
Primary outcome
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.
5 secondary outcomes
Nutritional Status
Time frame: Baseline, 5th and 9th weeks
Urinary Infection Risk Indicators
Time frame: Baseline, 5th and 9th weeks
Incontinence-Associated Dermatitis
Time frame: Baseline, 5th and 9th weeks
Skin Tears
Time frame: Baseline, 5th and 9th weeks
Urine Colour
Time frame: Baseline, 5th and 9th weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care-Up Electronic Decision Support System in people with Support of the Family as a Caregiving System, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure-Injury Risk (time frame: Baseline, 5th and 9th weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.