Pressure InjuriesNCT07074743
Evaluate the Feasibility and Effectiveness of a Community-based Care Bundle in Managing and Preventing Pressure Injuries
A study testing community-based PI care bundle and Wait-list in people with Pressure Injuries and Caregiver, run by Singapore General Hospital at 2 sites in Singapore.
Trial summary
Community-acquired pressure injuries are pressure injuries that developed outside of hospital, typically in the patient's own home environment. Pressure injuries (PI) used to be commonly known as bedsores or pressure ulcers. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pressure Injuries, Caregiver, Community Dwelling Older Adult
- What is being tested?
- community-based PI care bundle and Wait-list
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 2 sitesSingapore
- Study dates
- 26 Dec 2025to 30 Jun 2028
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients discharged from SGH with existing PI (any stages according to NPIAP and on any part of the body)
- have a family caregiver or FDH who will be managing the PI upon discharge
- patients will be discharged to home
- living within the SGH nursing community zones
Who cannot join
- previous or existing participation in this trial
- palliative or dying patients
- planned discharge to a nursing home or other hospital
- mobile inpatient care@home service
- patient or next-of-kin who refused to participate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Recruiting
Singapore General Hospital
Singapore, 168582
Fazila AB Aloweni, MSci, +65 63265796, fazila.abu.bakar.aloweni@sgh.com.sg
- Not yet recruiting
Singapore General Hospital
Singapore
Fazila Aloweni, MSci, +65 6326 5796, fazila.abu.bakar.aloweni@sgh.com.sg
About this study
Community-acquired pressure injuries are pressure injuries that developed outside of hospital, typically in the patient's own home environment. Pressure injuries (PI) used to be commonly known as bedsores or pressure ulcers.
The goal of this clinical trial is to evaluate if a community-based pressure injury (PI) care bundle is effective in treating and preventing pressure injuries in home settings. It will also assess how feasible it is to implement this care bundle in Singapore's community care context.
Read more
The main questions it aims to answer are:
- Does the PI care bundle help improve pressure injury healing (shown by at least a 3-point reduction on the PUSH score)?
- Can the care bundle prevent the development of new pressure injuries?
- How well do caregivers learn and apply PI care knowledge after receiving the educational intervention?
- How practical and acceptable is this care bundle for use in home settings?
The investigators will compare the PI care bundle to routine care (control group) to see if the care bundle works better for managing pressure injuries at home. Success will be measured using the PUSH tool, which scores pressure injuries from 0 (completely healed) to 17 (most severe). A reduction of at least 3 points on this scale will indicate meaningful improvement.
Participants and their caregivers will:
Be split into two groups - one group will use the new care plan (receive the PI care bundle), and the other will continue with their routine care.
Have their pressure injuries checked regularly for 6 weeks. Have their caregivers learn about pressure injury care. Answer questions about how well the care plan works for them.
The investigator hopes this study will help find better ways to treat or prevent pressure injuries at home and support the caregivers at home.
Read the detailed description
STUDY DESIGN and METHODOLOGY
This is a randomized controlled trial evaluating a community-based pressure injury (PI) care bundle versus routine care. The study employs a waitlist-control design with a 6-week intervention period.
OUTCOME MEASUREMENTS
Primary Outcome:
- Clinical improvement measured using the Pressure Ulcer Scale for Healing (PUSH) tool.
- Minimum clinically meaningful effect size established as 3-point reduction on PUSH score.
- PUSH scoring ranges from 0 (healed) to 17 (most severe)
Secondary Outcomes:
- Incidence of new pressure injuries
- Caregiver Knowledge, Attitudes, and Practices (KAP) assessment
Feasibility metrics including:
- Implementation appropriateness
- Intervention acceptability
- Protocol fidelity
- Participation and retention rates
- Adherence to prescribed prevention measures
TECHNICAL COMPONENTS OF CARE BUNDLE
The intervention group will receive:
- Using the aSSKINg framework, the investigators have co-design the content of PI prevention and management with the community nurses, WOC nurses and caregivers.
- Delivered a structured caregiver education program- tailored to the patient and caregiver needs.
- Weekly check in by the study team or community nurses
- Documentation and tracking tools using electronic wound imaging system.
DATA COLLECTION AND ANALYSIS
Standardized assessment tools for PI staging- PI staging follows National Pressure Injury Advisory Panel (NPIAP) standardized system.
Validated KAP questionnaires Feasibility assessment metrics Protocol adherence monitoring Dropout rate tracking
Statistical analysis comparing intervention versus control outcomes.
The study design incorporates rigorous methodology to evaluate both clinical effectiveness and implementation feasibility in the community setting, with specific attention to the unique challenges of home-based PI care management.
- Conditions
- Pressure Injuries, Caregiver, Community Dwelling Older Adult
- Being tested
- community-based PI care bundle, Wait-list
- Keywords
- pressure injuries, community nursing, care bundle
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community-based PI care bundleOther
The PI care bundle follows the aSSKINg model and is delivered in addition to routine care. Key components include:
Assessment Pre-discharge evaluation Ongoing skin, nutrition, and hydration monitoring Caregiver training for home assessment Equipment and Resources
Customized provision of necessary devices based on needs:
Sliding sheets Repositioning cushions Skin barriers Moisturizers Pressure-relieving overlays Alternating air mattresses Implementation Caregivers demonstrate device usage competency Documentation checklist for monitoring Regular follow-up by community nurses Professional Support Community nurses trained by PI specialists Standardized care protocols Regular effectiveness assessment
All participants receive routine care including:
Pre-discharge nutrition assessment Dietician referral if needed Educational materials Basic wound care referrals Hospital-to-home team support for complex cases The intervention provides structured, comprehensive support beyond standard care.
Wait-listOther
Also called routine care, usual care
During hospitalisation:
Patient's nutritional status assessed. Referred to a dietician before discharge if needed. Nurse assesses caregiver training needs and arranges training if required.
At discharge:
Patients receive PI educational pamphlets (hardcopy or softcopy). Emphasis on regular repositioning, skin inspection, proper nutrition, and hydration.
Patients with PI wounds:
Referred to home nursing or polyclinics for wound care. Only those with complex PI (stage >3) receive up to two follow-ups by the H2H care team.
H2H team supports general care transition, not PI-specific follow-up alone. Any signs of PI deterioration will be monitored weekly throughout the waiting period for safety and ethical considerations.
If the index PI advances to a higher stage and reports increased pain after a week, the investigator will refer them to a community wound care nurse and record this as a deterioration and will start PI care bundle
| Study group | Role | What they receive |
|---|---|---|
| Wait-list | Active comparator | The wait-list group will receive routine care during the first six weeks and at seven weeks, the index PI will be restaged and if patient is still having PI- the PI care bundle will be provided for the next six weeks. However, PI care bundle can also be initiated if the index PI advances to higher stage had increased pain over PI site or when there is deterioration of the index PI at any point during the weekly follow up.
Providing PI care bundle to wait-list control group after 6 week ensures ethical care while maintaining study integrity. Receives: Other: Wait-list |
| Community-based PI care bundle | Experimental | The community-based PI care bundle follows the aSSKINg model and is delivered in addition to routine care for six weeks. Receives: Other: community-based PI care bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure injury healing
The proportion of community-dwelling adults who achieve a reduction of at least 3 points on the PUSH score of the index PI at six weeks. The PUSH tool, with a range from 0 (healed) to 17 (worst score), provides a continuous outcome measure. The investigators have set a 3-point reduction as the minimum clinically meaningful effect size for this study.
Measured: at 6 weeks post randomisation
Secondary outcomes (1)
Caregiver's Knowledge, Attitude and Practice (KAP)
Changes in caregivers' KAP scores will be compared at baseline and six-week scores between groups.
Knowlege domain: 12 MCQs, lowest score 0 to highest 12. A cut of point of 65% will be considered sufficient.
Attitude domain: consist of 9 statements on PI prevention, participants will be asked to indicate the extent of their agreement from strongly agree (score 4) and strongly disagree (score 1). The sum score range 9 to 36; a higher score indicate more positive attitude.
Practice domain: consist of 12 statements PI preventive care measures. Using a Likert scale: never to always. The sum of score range 12 to 48. A higher score indicate better PI practice.
Measured: 6 weeks post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start26 Dec 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuriesStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, Singapore Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Fazila Aloweni, MSci, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074743
- Sponsor's protocol ID
- 2022/2406_CAPIcarebundle
- Status last verified
- Dec 2025
- First submitted
- 29 Jun 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Feasibility and Effectiveness of a Community-based Care Bundle in Managing and Preventing Pressure Injuries
- ClinicalTrials.gov ID
- NCT07074743
- Acronym / sponsor ID
- 2022/2406_CAPIcarebundle
- Conditions
- Pressure Injuries, Caregiver, Community Dwelling Older Adult
- Keywords
- pressure injuries, community nursing, care bundle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, Singapore Institute of Technology
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Jul 2025 (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.
Community-acquired pressure injuries are pressure injuries that developed outside of hospital, typically in the patient's own home environment. Pressure injuries (PI) used to be commonly known as bedsores or pressure ulcers.
The goal of this clinical trial is to evaluate if a community-based pressure injury (PI) care bundle is effective in treating and preventing pressure injuries in home settings. It will also assess how feasible it is to implement this care bundle in Singapore's community care context.
The main questions it aims to answer are:
- Does the PI care bundle help improve pressure injury healing (shown by at least a 3-point reduction on the PUSH score)?
- Can the care bundle prevent the development of new pressure injuries?
- How well do caregivers learn and apply PI care knowledge after receiving the educational intervention?
- How practical and acceptable is this care bundle for use in home settings?
The investigators will compare the PI care bundle to routine care (control group) to see if the care bundle works better for managing pressure injuries at home. Success will be measured using the PUSH tool, which scores pressure injuries from 0 (completely healed) to 17 (most severe). A reduction of at least 3 points on this scale will indicate meaningful improvement.
Participants and their caregivers will:
Be split into two groups - one group will use the new care plan (receive the PI care bundle), and the other will continue with their routine care.
Have their pressure injuries checked regularly for 6 weeks. Have their caregivers learn about pressure injury care. Answer questions about how well the care plan works for them.
The investigator hopes this study will help find better ways to treat or prevent pressure injuries at home and support the caregivers at home.
Detailed description
STUDY DESIGN and METHODOLOGY
This is a randomized controlled trial evaluating a community-based pressure injury (PI) care bundle versus routine care. The study employs a waitlist-control design with a 6-week intervention period.
OUTCOME MEASUREMENTS
Primary Outcome:
- Clinical improvement measured using the Pressure Ulcer Scale for Healing (PUSH) tool.
- Minimum clinically meaningful effect size established as 3-point reduction on PUSH score.
- PUSH scoring ranges from 0 (healed) to 17 (most severe)
Secondary Outcomes:
- Incidence of new pressure injuries
- Caregiver Knowledge, Attitudes, and Practices (KAP) assessment
Feasibility metrics including:
- Implementation appropriateness
- Intervention acceptability
- Protocol fidelity
- Participation and retention rates
- Adherence to prescribed prevention measures
TECHNICAL COMPONENTS OF CARE BUNDLE
The intervention group will receive:
- Using the aSSKINg framework, the investigators have co-design the content of PI prevention and management with the community nurses, WOC nurses and caregivers.
- Delivered a structured caregiver education program- tailored to the patient and caregiver needs.
- Weekly check in by the study team or community nurses
- Documentation and tracking tools using electronic wound imaging system.
DATA COLLECTION AND ANALYSIS
Standardized assessment tools for PI staging- PI staging follows National Pressure Injury Advisory Panel (NPIAP) standardized system.
Validated KAP questionnaires Feasibility assessment metrics Protocol adherence monitoring Dropout rate tracking
Statistical analysis comparing intervention versus control outcomes.
The study design incorporates rigorous methodology to evaluate both clinical effectiveness and implementation feasibility in the community setting, with specific attention to the unique challenges of home-based PI care management.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-list | Active comparator | Other: Wait-listThe wait-list group will receive routine care during the first six weeks and at seven weeks, the index PI will be restaged and if patient is still having PI- the PI care bundle will be provided for the next six weeks. However, PI care bundle can also be initiated if the index PI advances to higher stage had increased pain over PI site or when there is deterioration of the index PI at any point during the weekly follow up. Providing PI care bundle to wait-list control group after 6 week ensures ethical care while maintaining study integrity. |
| Community-based PI care bundle | Experimental | Other: community-based PI care bundleThe community-based PI care bundle follows the aSSKINg model and is delivered in addition to routine care for six weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients discharged from SGH with existing PI (any stages according to NPIAP and on any part of the body)
- have a family caregiver or FDH who will be managing the PI upon discharge
- patients will be discharged to home
- living within the SGH nursing community zones
Key exclusion criteria (5 listed)
- previous or existing participation in this trial
- palliative or dying patients
- planned discharge to a nursing home or other hospital
- mobile inpatient care@home service
- patient or next-of-kin who refused to participate.
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 |
|---|---|---|
| community-based PI care bundleThe PI care bundle follows the aSSKINg model and is delivered in addition to routine care. Key components include: Assessment Pre-discharge evaluation Ongoing skin, nutrition, and hydration monitoring Caregiver training for home assessment Equipment and Resources Customized provision of necessary devices based on needs: Sliding sheets Repositioning cushions Skin barriers Moisturizers Pressure-relieving overlays Alternating air mattresses Implementation Caregivers demonstrate device usage competency Documentation checklist for monitoring Regular follow-up by community nurses Professional Support Community nurses trained by PI specialists Standardized care protocols Regular effectiveness assessment All participants receive routine care including: Pre-discharge nutrition assessment Dietician referral if needed Educational materials Basic wound care referrals Hospital-to-home team support for complex cases The intervention provides structured, comprehensive support beyond standard care. | Other | Community-based PI care bundle |
| Wait-listAlso: routine care, usual careDuring hospitalisation: Patient's nutritional status assessed. Referred to a dietician before discharge if needed. Nurse assesses caregiver training needs and arranges training if required. At discharge: Patients receive PI educational pamphlets (hardcopy or softcopy). Emphasis on regular repositioning, skin inspection, proper nutrition, and hydration. Patients with PI wounds: Referred to home nursing or polyclinics for wound care. Only those with complex PI (stage >3) receive up to two follow-ups by the H2H care team. H2H team supports general care transition, not PI-specific follow-up alone. Any signs of PI deterioration will be monitored weekly throughout the waiting period for safety and ethical considerations. If the index PI advances to a higher stage and reports increased pain after a week, the investigator will refer them to a community wound care nurse and record this as a deterioration and will start PI care bundle | Other | Wait-list |
Primary outcome
Pressure injury healing
Time frame: at 6 weeks post randomisation
The proportion of community-dwelling adults who achieve a reduction of at least 3 points on the PUSH score of the index PI at six weeks. The PUSH tool, with a range from 0 (healed) to 17 (worst score), provides a continuous outcome measure. The investigators have set a 3-point reduction as the minimum clinically meaningful effect size for this study.
1 secondary outcome
Caregiver's Knowledge, Attitude and Practice (KAP)
Time frame: 6 weeks post randomisation
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 29 Apr 2026.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Fazila Aloweni, MSci principal investigator
Singapore General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing community-based PI care bundle and Wait-list in people with Pressure Injuries and Caregiver, run by Singapore General Hospital at 2 sites in Singapore.
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 5 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure injury healing (time frame: at 6 weeks post randomisation). 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 29 Apr 2026.