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

NCT07843888 | Not Yet Recruiting DMC

• 1 other identifier: CBU-NURS-FUA-02
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Home Care for Elderly or Disabled Individuals; Intervention; Multicomponent 12-week Program; Dementia; Decubitis Ulcer

Outcome Measures

Primary Outcomes (1)

• Braden Pressure Ulcer Risk Assessment Scale

  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.

Secondary Outcomes (1)

• Zarit Burden Interview

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

Study Arms (2)

Pressure Injury Prevention Education

EXPERIMENTAL

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.

Behavioral: Pressure Injury Prevention Education

Usual Care

NO INTERVENTION

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.

Interventions

Pressure Injury Prevention Education BEHAVIORAL

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

Pressure Injury Prevention Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Manisa Celal Bayar University: lead

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient-caregiver pairs (PCGs) consisting of individuals diagnosed with dementia and their primary caregivers receiving home care were randomised into intervention and control groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study was designed as a two-arm, parallel-group randomised controlled trial.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: September 28, 2026
• Study Start: September 1, 2026
• Primary Completion: September 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share