NCT04188990

Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition

Completed NA Last updated 21 September 2023

What this trial tests

NA trial testing Nutritional dietary intervention in Pancreatitis, Acute in 1,051 participants. Completed in 30 June 2023.

Timeline

15 June 2020

Primary endpoint
30 June 2022

30 June 2023

Quick facts

Lead sponsor	Hospital Galdakao-Usansolo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,051
Start date	15 June 2020
Primary completion	30 June 2022
Estimated completion	30 June 2023
Sites	2 locations across Spain

Drugs / interventions tested

• Nutritional dietary intervention
• By demand
• Usual current care

Conditions studied

• Pancreatitis, Acute — all drugs for Pancreatitis, Acute →
• Crohn Disease — all drugs for Crohn Disease →
• Ulcerative Colitis — all drugs for Ulcerative Colitis →
• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →

Sponsor

Hospital Galdakao-Usansolo

Who can join

18 and older, any sex, with Pancreatitis, Acute or Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objectives: To evaluate the effectiveness, and cost-effectiveness, of three hospitalized patient care strategies in relation to disease-related malnutrition (DRM) hospital admissions based on results such as length of stay of the index admission, and from admission until one year after admission, mortality rate, appearance of complications, changes in weight and nutritional state, changes in their health related quality of life and functional status, readmissions, use of health services resources (primary care, hospital and emergency consultations) and costs. Methodology: Intervention study involving three hospitals with three branches in which, after nutritional screening in all centers, the first branch / hospital includes a intervention strategy for nutritional improvement in patients who after screening are identified as having DRE or at risk of DRE, and follow-up of other patients; a second cohort / hospital will include similar patients in which if there is any nutritional intervention it will be carried out by demand of the medical staff in charge of the patient; and a third branch /hospital in which the usual practice of the center will be followed without any explicit intervention. Subjects of the study: At least 300 patients in each center admitted to the digestive services, due to digestive pathologies, and surgery services due to tumor and digestive system pathologies. In all patients, sociodemographic and clinical data will be collected and of the outcomes described above during admission and until the year of follow-up. Statistical analysis: through appropriate multiple regression models for each outcome variable and with adjustments through propensity scores to compare the three centers based on each outcome parameter. A cost-effectiveness analysis will be carried out through of the incremental cost for each year of quality-adjusted life (QALY) .

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gastrointestinal Cancer Patient Nutritional Management: From Specific Needs to Novel Epigenetic Dietary Approaches.
   Cencioni C, Trestini I, Piro G, Bria E, et al · · 2022 · cited 24× · PMID 35458104 · DOI 10.3390/nu14081542
2. The Human Microbiomes in Pancreatic Cancer: Towards Evidence-Based Manipulation Strategies?
   Brandi G, Turroni S, McAllister F, Frega G. · · 2021 · cited 15× · PMID 34576078 · DOI 10.3390/ijms22189914
3. Unlocking the Potential of Bioactive Compounds in Pancreatic Cancer Therapy: A Promising Frontier.
   Brugiapaglia S, Spagnolo F, Curcio C. · · 2025 · cited 1× · PMID 40427617 · DOI 10.3390/biom15050725
4. Health-Related Quality of Life Changes in Patients with Digestive Cancers and Chronic Digestive Diseases: A Prospective, Multicenter Study.
   Martín J, Larrea N, García Y, Bolinaga I, et al · · 2026 · PMID 42194559 · DOI 10.3390/jcm15103596
5. One-year post-discharge health-related quality of life in digestive and oncology patients: a three-group comparison by nutritional status and care.
   Martín J, Larrea N, García Y, Bolinaga I, et al · · 2025 · PMID 41452524 · DOI 10.1007/s11136-025-04139-y
6. Evaluation of clinical outcomes after an intervention in malnourished hospitalized patients.
   Garcia Y, Larrea N, Martin J, Bolinaga I, et al · · 2025 · PMID 41004975 · DOI 10.1016/j.clnu.2025.04.034