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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 1 to 2
    • Primary completion date: May 2027 to Sep 30, 2027
    • Study completion date: Jun 2028 to Jun 30, 2028
    • Start date changed from estimate of Dec 2025 to Dec 26, 2025
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07074743
Lead Sponsor Singapore General Hospital
Collaborators: Duke-NUS Graduate Medical School, Singapore Institute of Technology
Conditions
(from sponsor)
Pressure Injuries, Caregiver, Community Dwelling Older Adult
Related terms Pressure Ulcer
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov