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

Not Applicable

Not yet recruiting

• Conditions: Pressure Injuries; Caregiver; Community Dwelling Older Adult

• Registration Number: NCT07074743
• Lead Sponsor: Singapore General Hospital

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. Does the PI care bundle help improve pressure injury healing (shown by at least a 3-point reduction on the PUSH score)?

2. Can the care bundle prevent the development of new pressure injuries?

3. How well do caregivers learn and apply PI care knowledge after receiving the educational intervention?

4. 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 Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-29
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Study Start: 2025-12-01
• Primary Completion: 2027-05
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pressure injury healing	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.

Secondary Outcome Measures

Name	Time	Method
Caregiver's Knowledge, Attitude and Practice (KAP)	6 weeks post randomisation	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.

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore