Individualized nutrition care for home nursing patients with pressure injuries
Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries - A Cluster-Randomized, Pragmatic Clinical Trial and Economic Evaluation.
This study tests if personalized nutrition support can help adults with pressure injuries heal better while they receive care at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Changi General Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06078488 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a personalized nutrition intervention package aimed at improving healing rates of pressure injuries in adults receiving home nursing care. Participants will be randomly assigned to either an intervention group, which receives tailored nutritional support and education, or a control group that only receives educational materials. The study will assess various outcomes, including healing rates, quality of life, and cost-effectiveness over a 12-week period. The intervention includes dietary consultations and specialized nutritional supplements to meet individual energy and protein needs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with Stage II or higher pressure injuries receiving home nursing care.
Not a fit: Patients with terminal conditions or severe comorbidities that limit nutritional support may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance healing rates and quality of life for patients with pressure injuries.
How similar studies have performed: Previous studies have shown promising results with individualized nutritional interventions for wound healing, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult (age more than or equal to 21 years, any gender). 2. Stage II, III, IV, and unstageable pressure injuries. For patients with multiple wounds, we will include all the pressure injuries (stages II and above) in the investigation. 3. Able to provide written informed consent (patient or legal guardian). 4. Be on oral and/or enteral nutritional support. Exclusion Criteria: 1. Known palliative care individuals with a lifespan of \</= 3 months, 2. Known septicaemia, 3. Poorly controlled diabetes (glycated haemoglobin level \> 8.5%17), 4. Individuals on strict fluid restriction if the provision of additional oral or enteral nutrition supplements leads to excess intake, for the following conditions: 1. Advanced renal disease not on dialysis (KDIGO \[21, 22\] Stage G4 with an estimared Glomerular Filtration Rate (eGFR) of 15-29 ml/min/1.73m2 and Stage G5 with an eGFR less than 15 ml/min/1.73m2 2. Advanced decompensated alcoholic and non-alcoholic liver cirrhosis 3. Heart failure with reduced ejection fraction requiring fluid restriction less than 800ml per day, 6. Previous (last chemotherapy or radiotherapy less than one year ago) or current neoplastic disease 7. Currently on immunosuppressive therapy, 8. Known allergy reaction to L-arginine, phenylketonuria 9. Presence of an infected wound (if it is the only pressure injury present on the participant) 10. Presence of untreated diagnosed osteomyelitis.
Where this trial is running
Singapore
- Home Nursing Foundation — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Alvin Wong, MSc — SingHealth Duke NUS
- Study coordinator: Alvin Wong, MSc
- Email: alvin_wong@cgh.com.sg
- Phone: (65)64268775
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.