Biological Aging, Medication, Malnutrition and Inflammation Among Acutely Ill and Healthy Elderly.

NCT03052192 | Unknown DMC

• 3 other identifiers: FAM-CPH-cohortH-16038786AHH-2016-067 (I-suite 04931)
• Study Type: observational
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will investigate and characterize acute medical patients in order to optimize patient courses in the acute care departments, especially with regard to polypharmacy and undernourishment. In addition, the investigators will investigate underlying immunological mechanisms of chronic inflammation and biological aging in this population to improve the current knowledge and possibilities for preventing chronic diseases and acute hospitalization.

Conditions

Aging; Polypharmacy; Malnutrition; Inflammation; Emergency Service, Hospital

Outcome Measures

Primary Outcomes (5)

• Eating validation scheme score

  Development in nutritional status and risk factors of malnutrition within the FAM group.

  From inclusion to 4 weeks after discharge

• MAI score (Medication Appropriateness Index)

  Difference in summed MAI-score per patient. MAI score between inclusion and first follow-up visit (FAM group)

  From inclusion to 4 weeks after discharge

• NF-kB (Nuclear Factor Kappa light chain enhancer og activated B cells) activity

  The development in NF-kB activity between the groups will be investigated. The association of NF-kB activity with biological ageing-measured by chronic inflammation, and loss of function and cognition-will also be investigated.

  From inclusion to 56 weeks after discharge

• Chronic inflammation

  Stability and discriminative ability of new model for chronic inflammation (Control group 2)

  From inclusion to 4 weeks after inclusion

• NLRP3 activity

  Difference in NLRP3 inflammasome activity between groups.

  From inclusion to 56 weeks after discharge

Secondary Outcomes (13)

• Bodyweight (kg)

  From inclusion to 4 and 56 weeks after discharge

• Quality of life

  From inclusion to 56 weeks after discharge

• Medication under-prescribing

  From inclusion to 4 weeks after discharge

• Inflammation in malnourished patients

  4 weeks after discharge

• Functional recovery score

  From inclusion to 56 weeks after discharge

Other Outcomes (10)

• Sit-to-stand test

  From inclusion to 56 weeks after discharge

• Cognitive functional ability

  From inclusion to 56 weeks after discharge

• Waist circumference (cm)

  From inclusion to 56 weeks after discharge

Study Arms (3)

FAM group (n=98)

≥65 years. Acutely admitted medical patients. Included consecutively at admission to the Acute Medical Department at Amager and Hvidovre Hospital and Rigshospitalet - Glostrup. Follow-up at 4 weeks and 56 weeks after discharge and at any readmissions in the study period. Participants are interviewed on physical, mental and nutritional status, tested for functional and cognitive status, and have anthropometry, biochemistry, blood pressure, and immune activity measured. Participants are followed in national registries for information on diagnoses, hospital admissions, health care services used, and mortality. If a patient uses ≥5 prescribed drugs before hospitalization, a medication review will be performed by a clinical pharmacist and a geriatrician. Sample size calculations were performed for each primary outcome, and the final sample size was based on the calculation for the eating validation scheme which resulted in the largest sample size.

Control group 1 (n=54)

≥65 years. No hospital admissions within the past two years. Matched individually with patients in the FAM group by age, sex, and municipality. Examined at inclusion and 52 weeks after inclusion. Participants are interviewed on physical, mental and nutritional status, tested for functional and cognitive status, and have anthropometry, biochemistry, blood pressure, and immune activity measured. Participants are followed in national registries for information on diagnoses, hospital admissions, health care services used, and mortality.

Control group 2 (n=60)

20-35 years No admissions due to chronic or critical illness within the past 5 years (except admissions related to child birth, abortion, appendicitis, poisoning, traumas, concussion etc.) Examined at inclusion and 4 weeks after inclusion. The examination includes a questionnaire about life style, a physical examination, and blood samples.

Eligibility Criteria

• Age: 20 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Three study groups; the FAM group, control group 1 and control group 2

You may qualify if:

• ≥65 years
• Acute medical patient
• Understands and speaks Danish

You may not qualify if:

• Unable to cooperate cognitively
• Terminal patients
• Patients in isolation
• Control group 1:
• ≥65 years
• No hospital admissions within the past 2 years
• Acute admissions within the past 2 years
• Auto-immune diseases
• Treatment with immunosuppressive or biological therapies
• Control group 2:
• years
• Caucasian
• No admissions due to chronic or critical illness within the past 5 years (except admissions related to child birth, abortion, appendicitis, poisoning, traumas, concussion etc.)
• Auto-immune or chronic diseases

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Clinical Research Centre: collaborator
• Lundbeck Foundation: collaborator
• Region Hovedstadens Apotek: collaborator

Study Sites (1)

Amager & Hvidovre Hospital

Hvidovre, Capital Region, 2650, Denmark

Location

Related Publications (1)

• Bornaes O, Andersen AL, Houlind MB, Kallemose T, Tavenier J, Aharaz A, Nielsen RL, Jorgensen LM, Beck AM, Andersen O, Petersen J, Pedersen MM. Mild Cognitive Impairment Is Associated with Poorer Nutritional Status on Hospital Admission and after Discharge in Acutely Hospitalized Older Patients. Geriatrics (Basel). 2022 Sep 10;7(5):95. doi: 10.3390/geriatrics7050095.

  PMID: 36136804 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, serum, buffy coat.

MeSH Terms

Conditions

Malnutrition; Inflammation; Emergencies

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Ove Andersen, MD, PhD

  Hvidovre University Hospital

  STUDY CHAIR

• Morten B. Houlind, MSc

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Juliette Tavenier, MSc

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Line JH Rasmussen, MSc

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Aino L Andersen, MSc

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Research Centre

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: February 14, 2017
• Study Start: November 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)