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| Name | Class |
|---|---|
| Duke-NUS Graduate Medical School | OTHER |
| Singapore Institute of Technology | OTHER |
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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:
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.
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:
Secondary Outcomes:
Feasibility metrics including:
TECHNICAL COMPONENTS OF CARE BUNDLE
The intervention group will receive:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| community-based PI care bundle | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 6 weeks post randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the community-based PI care bundle | Feasibility will be assessed using acceptability indicator: (1) Acceptability, measured by patient and caregiver satisfaction using a self-validated questionnaire, with success defined as high satisfaction (>70%), high participation (>70%), and low dropout rates (<20%); | At completion of the study, i.e. at the end of 6 weeks. |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Fazila Aloweni, MSci | Singapore General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Recruiting | Singapore | 168582 | Singapore |
all IPD that underlie results in a publication
Beginning 1 months and ending 1 years after the publication of results
The PI's research office will review the request
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|
| Wait-list | Other | 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 |
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| 6 weeks post randomisation |
| Feasibility of the community-based PI care bundle | Feasibility will be assessed using adherence indicator: (2) Adherence, measured as the proportion of patients and caregivers following recommended PI prevention measures, with a target of ≥70% | At completion of the study, i.e. at the end of 6 weeks. |
| Feasibility of the community-based PI care bundle | Feasibility will be assessed using fidelity indicator: (3) Fidelity, evaluated through audits of care bundle implementation, with success defined as achieving ≥80%. | At completion of the study, i.e. at the end of 6 weeks. |
| Singapore General Hospital | Not yet recruiting | Singapore | Singapore |
|
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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