Support of the Family as a Caregiving System
Conditions
Keywords
decision support system, pressure ulcer, urinary infection, home care, infection risk, dependent patients, informal caregiver
Brief 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. 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.
Interventions
OTHERCare-Up Electronic Decision Support System
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.
Sponsors
Akdeniz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Blinding of participants and the researcher delivering the intervention was not feasible because caregivers knowingly used the electronic decision support system. Formal outcome assessors were not blinded. The statistician analysing the data was blinded to group identity.
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Patients with a Barthel Index total score of 0-20 (fully dependent) or 21-61 (severely dependent). 3. An informal caregiver providing care at home who could use a mobile device and the Care-Up web-based system. 4. Caregivers with an Adult Digital Literacy Scale score of at least 61 on the standardised 0-100 scale. 5. Caregivers who were literate in Turkish and voluntarily agreed to participate.
Exclusion criteria
1. Patients with a Barthel Index score of 62 or above. 2. Patients with an acute medical condition, such as an infection requiring hospitalisation or a newly developed severe illness. 3. Caregivers with cognitive or technological limitations preventing use of Care-Up, including lack of access to the required technology. 4. Caregivers who were not literate in Turkish. 5. Patients with terminal illness and a short life expectancy. 6. Caregivers with severe cognitive impairment or an untreated psychiatric disorder affecting participation. 7. Patients without an informal caregiver at home. 8. Patients with an existing urinary infection identified from hospital records at baseline. 9. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure-Injury Risk | 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
| Measure | Time frame | Description |
|---|---|---|
| Nutritional Status | 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. |
| Urinary Infection Risk Indicators | 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. |
| Incontinence-Associated Dermatitis | 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. |
| Skin Tears | 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. |
| Urine Colour | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed