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NCT Number: NCT07074743

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

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.

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Key information

Conditions

Pressure Injuries Caregiver Community Dwelling Older Adult Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

Other names: routine care, usual care

Primary outcomes

  1. 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.

Secondary outcomes

  1. Caregiver's Knowledge, Attitude and Practice (KAP)

    Time frame: 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.

Other outcomes

  1. Feasibility of the community-based PI care bundle

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

    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%);

  2. Feasibility of the community-based PI care bundle

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

    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%

  3. Feasibility of the community-based PI care bundle

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

    Feasibility will be assessed using fidelity indicator:

    (3) Fidelity, evaluated through audits of care bundle implementation, with success defined as achieving ≥80%.

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • Duke-NUS Graduate Medical School
  • Singapore Institute of Technology

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 20, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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