NCT03741283

Brief Summary

Malnutrition and inappropriate medication prescribing are highly prevalent among acutely admitted older medical patients leading to re-admissions, frailty, poor physical, performance compromised quality of life and mortality. Thus, the aim of this study is to optimise the nutrition and medication in older medical patients admitted to an acute care department at admission and up to 16 weeks after discharge. Participants in the intervention group receives a medication review and participants with malnutrition or risk of malnutrition additionally receive a transitional multimodal intervention. The control group receives standard care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

3.8 years

First QC Date

November 5, 2018

Last Update Submit

August 24, 2021

Conditions

AgingMalnutritionDrug Prescribing

Keywords

Medicines optimisationMultimodal interventionsInflammationEmergency Service, HospitalPharmacogeneticsRenal functionFood intakeQuality of lifePolypharmacy

Outcome Measures

Primary Outcomes (3)

  • Changes in quality of life score EuroQol- 5 Dimensions- 5 Levels (sub-study 1)

    Patient administered quality of life scoring system with focus on mobility, daily activities, pain and discomfort and depression.

    Baseline (admission day), week 8 and week 16.

  • Changes in Medication Appropriateness Index-score" (sub-study 2)

    Medical physician, geriatric or senior pharmacist perform the MAI-scoring to evaluate the appropriateness of the medication prescribing.

    Baseline (admission day), week 8 and week 16.

  • Accuracy of renal function estimates (sub-study 3) - cystatin C

    Differences between GFR measured by a renally excreted radioactive labeled isotope (chromium 51-Cr-EDTA or 99mTc diethylenetriaminepentaacetic acid) and estimated GFR based on Creatinine and Cystatin C or a combination of the biomarkers.

    Baseline (admission day) or no later than 14 days after admission

Secondary Outcomes (28)

  • Walking speed to evaluate the development in physical performance

    Baseline (admission day), week 8 and week 16.

  • Functional measurement to evaluate the development in physical performance

    Baseline (admission day), week 8 and week 16.

  • Functional measurement to evaluate the development in physical performance

    Baseline (admission day), week 8 and week 16.

  • Functional measurement to evaluate the development in physical performance

    Baseline (admission day), week 8 and week 16.

  • Measure of physically active time and number of steps taken

    Week 1, week 8 and week 16 after discharge

  • +23 more secondary outcomes

Other Outcomes (3)

  • Number and types of actionable gene variants - Pharmacogenetic test

    Baseline (admission day)

  • Number and types of recommended therapy changes -Pharmacogenetic test

    Baseline (admission day)

  • Health economy related to Sub-study 1

    Baseline (admission day), week 8 and week 16 and 1 year after discharge

Study Arms (2)

Optimisation of nutrition and medication

EXPERIMENTAL

N=approx. 65 acutely admitted older medical patients with undernutrition or risk of undernutrition, and 35 without undernutrition or risk of undernutrition.

Other: Optimisation of nutrition and medication

Standard care

NO INTERVENTION

N= approx. 65 acutely admitted older medical patients with undernutrition or risk of undernutrition, and 35 without undernutrition or risk of undernutrition.

Interventions

Optimisation of nutrition and medicationOTHER

1. Inter-professional optimisation of medication prescribing: Study participants in the intervention group receives optimisation of medication prescribing at admission day (baseline) regardless of nutritional state. The intervention is performed in cooperation between a clinical pharmacist and a medical physician. 2. Nutritional intervention: If positive screening for malnutrition or risk of malnutrition a dietetic intervention is initiated and if positive screening below interventions are initiated: * Dysphagia: occupational therapy intervention. * Oral cavity problems: odontological intervention. * Depression: geriatric intervention. * Low ADL: occupational therapy intervention and if positive screening for poor muscle strength: physiotherapeutic intervention.

Optimisation of nutrition and medication

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥65 years
  • Acutely admitted medical patients
  • Understand and speak Danish
  • Caucasian
  • Resident in Municipality: Brøndby, Hvidovre or Copenhagen

You may not qualify if:

  • Unable to cooperate cognitively
  • Terminal/suicidal patients
  • Patients in isolation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amager & Hvidovre Hospital

Hvidovre, Capital Region, 2650, Denmark

Location

Related Publications (2)

  • Andersen AL, Houlind MB, Nielsen RL, Jorgensen LM, Bengaard AK, Bornaes O, Juul-Larsen HG, Hansen NM, Brochner LD, Hansen RG, Skovlund CAR, Pedersen AML, Beck AM, Pedersen MM, Petersen J, Andersen O. Effectiveness of a multidisciplinary and transitional nutritional intervention compared with standard care on health-related quality of life among acutely admitted medical patients aged >/=65 years with malnutrition or risk of malnutrition: A randomized controlled trial. Clin Nutr ESPEN. 2024 Jun;61:52-62. doi: 10.1016/j.clnesp.2024.02.031. Epub 2024 Mar 13.

    PMID: 38777473DERIVED

  • Iversen E, Bengaard AK, Leegaard Andersen A, Tavenier J, Nielsen RL, Juul-Larsen HG, Jorgensen LM, Bornaes O, Jawad BN, Aharaz A, Walls AB, Kallemose T, Dalhoff K, Nehlin JO, Hornum M, Feldt-Rasmussen B, Damgaard M, Andersen O, Houlind MB. Performance of Panel-Estimated GFR Among Hospitalized Older Adults. Am J Kidney Dis. 2023 Dec;82(6):715-724. doi: 10.1053/j.ajkd.2023.05.004. Epub 2023 Jul 28.

    PMID: 37516299DERIVED

MeSH Terms

Conditions

MalnutritionInflammationEmergencies

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Ove Andersen, MD, PhD

    Hvidovre University Hospital

    STUDY CHAIR

  • Aino L. Andersen, MSc

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Clinical Research Centre

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 14, 2018

Study Start

October 15, 2018

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)