Malnutrition Clinical Trial
— INCAOfficial title:
Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries - A Cluster-Randomized, Pragmatic Clinical Trial and Economic Evaluation.
NCT number | NCT06078488 |
Other study ID # | INCA |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 23, 2023 |
Est. completion date | June 30, 2025 |
Objective: To evaluate the impact of an individualized nutrition intervention package on pressure injury healing rates, prevention of new pressure injuries, complications, quality of life, and cost-effectiveness in adult on home nursing care with pressure injuries staged II and above in Singapore. Study Design: A two-group, non-blinded, randomized, pragmatic clinical trial with a cost-effectiveness analysis. Location/ Setting: Community Participants: Adults (aged 21 years and above) receiving home nursing care with at least one pressure injury (Stage II, III, IV, or Unstageable). 190 subjects per arm Intervention: The intervention group will receive an individualized nutrition intervention package consisting of individualized nutritional supplementation, specialized nutritional education pamphlets, regular dietetic support via home visits or telehealth, and home nursing care by nurses trained in nutrition care. The control group will receive specialized nutritional educational pamphlets, and home nursing care by nurses trained in nutrition care, with or without nutritional supplementation. Outcome Measures: Main outcomes of wound area reduction, and proportion of participants with >40% area reduction at 30 days, 60 days and 90 days. Secondary outcomes include proportion of participants and wounds with increasing severity of PI stages (e.g., stage II to stage III), improvement in Health-Related Quality of Life (HRQOL) and nutritional status, and incidence of wound infections at 30 days, 60 days and 90 days, proportion of participants with complete healing, mortality and unplanned hospital admissions. Economic Evaluation: The primary economic outcome will be the incremental cost-effectiveness ratio (ICER) per pressure injury prevented, with a time horizon of 1 year for intervention versus control during the period of intervention (3-months) and up to a year. Statistical Analyses: Individual patient level analysis will be performed as per our primary analysis, and we will also perform cluster level analysis. Hazard ratios (HR) will be determined using Cox proportional hazards models and their corresponding 95% Confidence Intervals (95%CI). Imbalances in individual level data will be accounted for using statistical adjustment in a Mixed-Effects Cox Regression model. Hypothesis: This study aims to provide evidence on the effectiveness and cost-effectiveness of a individualized and protocolized nutrition intervention package for pressure injury management in home care patients. The findings could inform the development of evidence-based guidelines and recommendations for nutritional care and education in this vulnerable population, ultimately leading to improved patient outcomes and reduced healthcare costs associated with pressure injuries.
Status | Recruiting |
Enrollment | 380 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Singapore | Home Nursing Foundation | Singapore |
Lead Sponsor | Collaborator |
---|---|
Changi General Hospital | Duke-NUS Graduate Medical School, Home Nursing Foundation (HNF), Temasek Foundation |
Singapore,
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Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial Study Group. A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial. Ann Intern Med. 2015 Feb 3;162(3):167-74. doi: 10.7326/M14-0696. Erratum In: Ann Intern Med. 2015 Dec 15;163(12):964. — View Citation
Chaboyer W, Bucknall T, Webster J, McInnes E, Gillespie BM, Banks M, Whitty JA, Thalib L, Roberts S, Tallott M, Cullum N, Wallis M. The effect of a patient centred care bundle intervention on pressure ulcer incidence (INTACT): A cluster randomised trial. Int J Nurs Stud. 2016 Dec;64:63-71. doi: 10.1016/j.ijnurstu.2016.09.015. Epub 2016 Sep 23. — View Citation
European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel, and Pan Pacific Pressure Injury Alliance, Prevention and Treatment of Pressure Ulcers/Injuries: Quick Reference Guide., E. Haesler, Editor. 2019
Goh OQ, Ganesan G, Graves N, Ng YZ, Harding K, Tan KB. Incidence of chronic wounds in Singapore, a multiethnic Asian country, between 2000 and 2017: a retrospective cohort study using a nationwide claims database. BMJ Open. 2020 Sep 25;10(9):e039411. doi: 10.1136/bmjopen-2020-039411. — View Citation
Graves, N. and H. Zheng, The prevalence and incidence of chronic wounds: a literature review. Wound Practice & Research: Journal of the Australian Wound Management Association, 2014. 22(1): p. 4-12
Husereau D, Drummond M, Augustovski F, de Bekker-Grob E, Briggs AH, Carswell C, Caulley L, Chaiyakunapruk N, Greenberg D, Loder E, Mauskopf J, Mullins CD, Petrou S, Pwu RF, Staniszewska S; CHEERS 2022 ISPOR Good Research Practices Task Force. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) Statement: Updated Reporting Guidance for Health Economic Evaluations. Value Health. 2022 Jan;25(1):3-9. doi: 10.1016/j.jval.2021.11.1351. — View Citation
Langer G, Fink A. Nutritional interventions for preventing and treating pressure ulcers. Cochrane Database Syst Rev. 2014 Jun 12;2014(6):CD003216. doi: 10.1002/14651858.CD003216.pub2. — View Citation
Lo ZJ, Lim X, Eng D, Car J, Hong Q, Yong E, Zhang L, Chandrasekar S, Tan GWL, Chan YM, Sim SC, Oei CW, Zhang X, Dharmawan A, Ng YZ, Harding K, Upton Z, Yap CW, Heng BH. Clinical and economic burden of wound care in the tropics: a 5-year institutional population health review. Int Wound J. 2020 Jun;17(3):790-803. doi: 10.1111/iwj.13333. Epub 2020 Mar 9. — View Citation
Munoz N, Posthauer ME, Cereda E, Schols JMGA, Haesler E. The Role of Nutrition for Pressure Injury Prevention and Healing: The 2019 International Clinical Practice Guideline Recommendations. Adv Skin Wound Care. 2020 Mar;33(3):123-136. doi: 10.1097/01.ASW.0000653144.90739.ad. — View Citation
Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, Salomon JA, Sculpher MJ, Trikalinos TA, Russell LB, Siegel JE, Ganiats TG. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 2016 Sep 13;316(10):1093-103. doi: 10.1001/jama.2016.12195. Erratum In: JAMA. 2016 Nov 8;316(18):1924. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adherence to Nutrition Supplementation Intake | Adherence to nutrition supplementation assessed by the number of participants with >75% consumption of oral nutritional supplements and Arginaid, where the servings of products consumed are counted w confirmation of intake during follow-up. | 30 days, 60 days and 90 days | |
Other | Hospital Length of Stay | Hospital Length of Stay assessed by the number of days for each unplanned hospital admission. | 1 year | |
Other | Wound Depth | Wound Depth measured (millimeters) using sterile forceps and ruler at follow-up. | 30 days, 60 days, 90 days, 6 months and 1 year | |
Other | Wound Duration | Measured by days to complete heal for participants with complete wound healing. | 1 year | |
Primary | Change in the area of pressure injury from baseline | Assessed by the change in wound area from baseline to the follow-up timepoints, measured with a 3D wound imaging device at the time of follow-up. | Baseline, 30 days, 60 days, 90 days, 6 months and 1 year | |
Primary | Percentage (%) of participants at time of follow-up with pressure injury wound area reduction of >/=40% | Percentage (%) of participants at time of follow-up with wound area reduction >/= 40%, at time of follow-up versus baseline, where the number of patients with wound area reduction >/= 40% at follow-up timeframe will be determined as a percentage of total number of participants in the study group. | Baseline, 30 days, 60 days, 90 days, 6 months and 1 year | |
Secondary | Proportion of participants with complete wound healing of the main wound | Proportion of participants with complete wound healing of the main wound. Assessed by the number of participants with complete healing of a wound, determined by clinical assessment and pressure injury staging. | 30 days, 60 days, 90 days, 6 months and 1 year | |
Secondary | Proportion of participants with increased severity of pressure injury (PI stage) | Proportion of participants with increased severity of pressure injury (PI stage). Assessed by the number of participants with increased severity of wound at follow-up. Severity of pressure injury determined by the increase in pressure injury staging, or increase in area of wound if pressure injury staging remains the same at the follow-up time points | 30 days, 60 days, 90 days, 6 months and 1 year | |
Secondary | Proportion of participants with new wound infection | Proportion of participants with New wound infection. Assessed by the number of participants with a new wound infection(s) at follow-up, that is clinically diagnosed with confirmation from blood tests (e.g., C-Reactive Protein (CRP), renal and liver function tests). | 30 days, 60 days, 90 days, 6 months and 1 year | |
Secondary | Change in Health-Related Quality of Life (HRQOL) utility scores from baseline to time of follow-up. | Change in HRQOL assessed by the change in the EuroQOL 5-Dimensions 5-Levels (EQ5D-5L) utility scores at follow-up from baseline for the overall population and age categories if appropriate, where change in scores expressed as mean differences or standardised mean differences. | 90 days, 6 months and 1 year | |
Secondary | Change in Health-Related Quality of Life (HRQOL) Visual Analogue Scale (VAS) scores from baseline to time of follow-up. | Change in HRQOL assessed by the change in the EuroQOL 5-Dimensions 5-Levels (EQ5D-5L) Visual Analogue Scale (VAS) at follow-up from baseline for the overall population and age categories if appropriate, where change in scores expressed as mean differences or standardised mean differences. | 90 days, 6 months and 1 year | |
Secondary | Change in Nutritional status. | Change in Nutritional status. Assessed using the Global Leadership Initiative on Malnutrition (GLIM) criteria, to determine the severity of malnutrition. Change in the nutritional status determined by direction of nutritional status shift from baseline to follow-up. | 30 days, 60 days, 90 days and 1 year | |
Secondary | Change in Nutritional Intake. | Change in Nutritional Intake. Assessed by the change in average of energy, protein and selected micronutrient intake derived from 3day food records. | 30 days and 60 days | |
Secondary | Mortality | Mortality assessed by the occurrence and time-to-event of all-cause mortality during the study period. | 30 days, 60 days, 90 days, 6 months and 1 year | |
Secondary | Unplanned Hospital Admission | Unplanned hospital admission assessed by the occurrence and time-to-event of one or more admissions during the study period. | 30 days, 60 days, 90 days, 6 months and 1 year |
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