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The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia

30 oktober 2026 bijgewerkt door: Fatma Uyar Açışlı, Manisa Celal Bayar University

The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia: A Randomised Controlled Trial

Introduction and Aim: Pressure ulcers are preventable complications that are common, particularly in individuals with dementia cared for at home, reducing quality of life and creating significant costs for the healthcare system. The risk of pressure ulcers increases in individuals with dementia due to mobility limitations, communication difficulties, and caregiver dependency; in a home care setting, the knowledge and skill deficiencies of caregivers further exacerbate this risk. The aim of this study is to evaluate the effectiveness of a multi-component training, monitoring, and reminder intervention developed for caregivers of individuals with dementia cared for at home in reducing the risk of pressure ulcers and the development of new pressure ulcers compared to standard care.

This study goes beyond the predominantly institution- and hospital-based approaches in the literature on pressure ulcer prevention, offering a structured, experimental intervention model specific to individuals with dementia cared for at home and their caregivers. This study aims to present a caregiver-based, feasible, and low-cost model for the prevention of pressure ulcers in individuals with dementia receiving home care, and to contribute the findings to scientific publications and home care services. Method: The study was designed as a two-arm, parallel-group randomized controlled experimental design. Patient-caregiver pairs (PCGs) consisting of individuals diagnosed with dementia and their primary caregivers receiving home care were randomized into intervention and control groups. The intervention group (n=60) received a 12-week multi-component program consisting of structured training sessions for caregivers, daily pressure ulcer prevention checklists, weekly coaching sessions, and text message reminders. The control group (n=60) received standard care and general information. The primary outcomes of the project were pressure ulcer risk (Braden Pressure Ulcer Risk Assessment Scale) and the development of new pressure ulcers. Secondary outcomes included caregiver knowledge level, adherence to preventive care practices, and changes in caregiver burden. The obtained data were statistically analyzed.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Geschat)

120

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Individuals clinically diagnosed with dementia,
  • Home-cared for,
  • At risk of pressure ulcers (Braden Pressure Ulcer Risk Assessment Scale ≤18),
  • Having at least one primary caregiver, and the caregiver agreeing to participate in the study.

Exclusion Criteria:

  • Presence of stage 3 or 4 pressure ulcer,
  • Hospitalisation within the last month.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Pressure Injury Prevention Education

The intervention group (n=60) received a 12-week multi-component program consisting of structured training sessions for caregivers, daily pressure ulcer prevention checklists, weekly coaching sessions, and text message reminders.

Structured Training Sessions (The training program consists of the following main topics: Basic Knowledge of Pressure Ulcers Skin Assessment and Care Positioning Nutrition and Hydration Pressure Reduction), Daily Pressure Ulcer Prevention Checklist, Coaching and Follow-up Meetings, Reminder Messages

Geen tussenkomst: Usual Care

Caregivers in the control group (n=60) will only receive a general informational brochure as part of standard care. No training or monitoring interventions will be applied to this group. In accordance with ethical principles, participants in the control group will also be provided with access to training materials after the study is completed.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Braden Pressure Ulcer Risk Assessment Scale
Tijdsspanne: This will be evaluated with T0 (baseline), T1 (week 6) and T2 (week 12) measurements.

The Braden Scale for Predicting Pressure Sore Risk consists of six subscales: sensory perception, moisture, activity, mobility, nutrition, and friction/shear. The first five subscales are scored from 1 to 4, while friction/shear is scored from 1 to 3. Total scores range from 6 to 23, with lower scores indicating a higher risk of pressure injury. Scores of ≤12 indicate high risk, 13-14 moderate risk, and 15-16 low risk. For individuals aged 75 years or older, scores of 15-18 are considered indicative of low risk.

This will be evaluated with T0 (baseline), T1 (week 6) and T2 (week 12) measurements.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Zarit Burden Interview
Tijdsspanne: Assessment will be based on T0 (baseline), T1 (week 6), and T2 (week 12) measurements.

The scale consists of 22 items, each scored from 0 (never) to 4 (nearly always). The total score ranges from 0 to 88, with higher scores indicating greater caregiver burden.

Assessment will be based on T0 (baseline), T1 (week 6), and T2 (week 12) measurements.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

10 mei 2027

Primaire voltooiing (Geschat)

15 oktober 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

24 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 september 2026

Eerst geplaatst (Werkelijk)

28 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 november 2026

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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