DementiaNCT07843888
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
A study testing Pressure Injury Prevention Education in people with Dementia and Home Care for Elderly or Disabled Individuals, run by Manisa Celal Bayar University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Home Care for Elderly or Disabled Individuals, Decubitis Ulcer
- What is being tested?
- Pressure Injury Prevention Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2027to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of stage 3 or 4 pressure ulcer,
- Hospitalisation within the last month.
About this study
Official title: 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.
- Conditions
- Dementia, Home Care for Elderly or Disabled Individuals, Decubitis Ulcer, Intervention, Multicomponent 12-week Program
- Being tested
- Pressure Injury Prevention Education
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Injury Prevention EducationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This will be evaluated with T0 (baseline), T1 (week 6) and T2 (week 12) measurements.
Secondary outcomes (1)
Zarit Burden Interview
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.
Measured: Assessment will be based on T0 (baseline), T1 (week 6), and T2 (week 12) measurements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start10 May 2027 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as a two-arm, parallel-group randomised controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Uyar Açışlı, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843888
- Sponsor's protocol ID
- CBU-NURS-FUA-02
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07843888
- Acronym / sponsor ID
- CBU-NURS-FUA-02
- Conditions
- Dementia, Home Care for Elderly or Disabled Individuals, Decubitis Ulcer, Intervention, Multicomponent 12-week Program
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 10 May 2027 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Sep 2026 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was designed as a two-arm, parallel-group randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Pressure Injury Prevention Education | Experimental | Behavioral: Pressure Injury Prevention EducationThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Presence of stage 3 or 4 pressure ulcer,
- Hospitalisation within the last month.
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 |
|---|---|---|
| Pressure Injury Prevention EducationStructured 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 | Behavioural | Pressure Injury Prevention Education |
Primary outcome
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.
1 secondary outcome
Zarit Burden Interview
Time frame: Assessment will be based on T0 (baseline), T1 (week 6), and T2 (week 12) measurements.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure Injury Prevention Education in people with Dementia and Home Care for Elderly or Disabled Individuals, run by Manisa Celal Bayar University.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Braden Pressure Ulcer Risk Assessment Scale (time frame: This will be evaluated with T0 (baseline), T1 (week 6) and T2 (week 12) measurements.). 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 2 Nov 2026.