Evaluate the Feasibility and Effectiveness of a Community-based Care Bundle in Managing and Preventing Pressure Injuries

NCT07074743 | Recruiting DMC

• 1 other identifier: 2022/2406_CAPIcarebundle
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

Brief 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. 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:

1. 1.Does the PI care bundle help improve pressure injury healing (shown by at least a 3-point reduction on the PUSH score)?
2. 2.Can the care bundle prevent the development of new pressure injuries?
3. 3.How well do caregivers learn and apply PI care knowledge after receiving the educational intervention?
4. 4.How practical and acceptable is this care bundle for use in home settings?

Conditions

Community Dwelling Older Adult; Pressure Injuries; Caregiver

Keywords

pressure injuries; community nursing; care bundle

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Caregiver's Knowledge, Attitude and Practice (KAP)

  6 weeks post randomisation

Other Outcomes (3)

• Feasibility of the community-based PI care bundle

  At completion of the study, i.e. at the end of 6 weeks.

• Feasibility of the community-based PI care bundle

  At completion of the study, i.e. at the end of 6 weeks.

• Feasibility of the community-based PI care bundle

  At completion of the study, i.e. at the end of 6 weeks.

Study Arms (2)

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.

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.

Other: community-based PI care bundle

Interventions

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.

Community-based PI care bundle

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

Also known as: routine care, usual care

Wait-list

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore General Hospital: lead
• Duke-NUS Graduate Medical School: collaborator
• Singapore Institute of Technology: collaborator

Study Sites (2)

Singapore General Hospital

Singapore, 168582, Singapore

RECRUITING

Singapore General Hospital

Singapore, Singapore

NOT YET RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Fazila Aloweni, MSci

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 20, 2025
• Study Start: December 26, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Beginning 1 months and ending 1 years after the publication of results
• Access Criteria: The PI's research office will review the request

Locations

SG (2)