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

October 30, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Pressure Injury Prevention Education

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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Braden Pressure Ulcer Risk Assessment Scale
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Zarit Burden Interview
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Manisa Celal Bayar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CBU-NURS-FUA-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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