AzTrials
AzTrials

AgingFAM-CPHNCT03052192

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

An observational study of Aging and Polypharmacy, run by Hvidovre University Hospital at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 110 yearsHealthy volunteers can take part
Conditions the study is for
Aging, Polypharmacy, Malnutrition
How many people
212 participants
Where
1 siteDenmark
Study dates
Nov 2016to Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 110 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • ≥65 years
  • Acute medical patient
  • Understands and speaks Danish
  • ≥65 years
  • No hospital admissions within the past 2 years
  • 20-35 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.)

Who cannot join

  • Unable to cooperate cognitively
  • Terminal patients
  • Patients in isolation
  • Control group 1:
  • Acute admissions within the past 2 years
  • Auto-immune diseases
Show all 9Show fewer
  • Treatment with immunosuppressive or biological therapies
  • Control group 2:
  • Auto-immune or chronic diseases

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Amager & Hvidovre Hospital

    Hvidovre, Capital Region, 2650

Other trials in Denmark

About this study

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.

Read the detailed description

Malnutrition:

Malnutrition among elderly is associated with frailty, including loss of weight, muscle mass, function and quality of life and also with an increased number of hospital admissions. In this study, the investigators aim to describe the development of and the risk factors for malnutrition from admission to 4 weeks after discharge, in addition the investigators wish to characterize the inflammatory state of the malnourished patients.

Inappropriate polypharmacy:

The broad variation among elderly in health, number of chronic diseases, organ function, biological age and function makes the prescription of drugs to this population a very complex task with a high risk of inappropriate medication. 5-30% of all non-elective admissions are caused by inappropriate medications, and many of these are preventable. Therefore, the investigators aim to investigate the feasibility of a pharmacist-geriatrician medication review in the acute care department and the effect on the Medication Appropriateness Index score (MAI-score) .

Chronic inflammation and biological aging:

Chronic inflammation and biological aging promote the development of age-related chronic diseases. There is a large variation in the rate of aging between individuals, in particular among the elderly. This means that the chronological age of a person often does not reflect its true state of aging, the biological age. This challenges the ability to provide appropriate care and to predict responses to treatment and interventions in elderly patients. The underlying causes and mechanisms of biological aging and chronic inflammation are not well understood. There are currently no validated methods for measuring biological age and no measures of chronic inflammation which can be used in an acute setting. Here, the investigators aim to test a novel model for chronic inflammation and investigate the role of the NLRP3 inflammasome, NFkB (nuclear factor kappa light chain enhancer of activated B cells) and miRNAs in biological aging and chronic inflammation.

The study is prospective with 3 groups of study participants: one group is included in the Acute Medical Department and two healthy control groups (one young and one older). The follow-up comprises two predefined examinations and any readmissions at our hospital. Furthermore, participants are followed in the national registries.

Medical subject headings
Malnutrition, Inflammation, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03052192
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eating validation scheme score

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

    Measured: From inclusion to 4 weeks after discharge

  2. MAI score (Medication Appropriateness Index)

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

    Measured: From inclusion to 4 weeks after discharge

  3. 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.

    Measured: From inclusion to 56 weeks after discharge

  4. Chronic inflammation

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

    Measured: From inclusion to 4 weeks after inclusion

  5. NLRP3 activity

    Difference in NLRP3 inflammasome activity between groups.

    Measured: From inclusion to 56 weeks after discharge

Secondary outcomes (13)

  1. Bodyweight (kg)

    Development in bodyweight

    Measured: From inclusion to 4 and 56 weeks after discharge

  2. Quality of life

    EQ-5D-5L(EuroQol-5Dimentions-5Llevels), mini geriatric depression score

    Measured: From inclusion to 56 weeks after discharge

  3. Medication under-prescribing

    Assessment of underutilization Index (AOU)

    Measured: From inclusion to 4 weeks after discharge

  4. Inflammation in malnourished patients

    Characterize the level of inflammation in malnourished patients

    Measured: 4 weeks after discharge

  5. Functional recovery score

    Assessing activities of daily living to characterize development in physical performance

    Measured: From inclusion to 56 weeks after discharge

  6. Cystatin C

    Measured: From inclusion to 56 weeks after discharge

  7. Cytokine concentrations

    The concentration of cytokines at baseline and in response to stimulation will be measured

    Measured: From inclusion to 56 weeks after discharge

  8. Cytometry

    Characterization of immune cell subsets

    Measured: From inclusion to 56 weeks after discharge

  9. miRNA

    Levels of miRNA will be measured, and their association with NF-kB activity and biological ageing will be investigated.

    Measured: From inclusion to 56 weeks after discharge

  10. NF-kB activation

    The activation of NF-kB in response to stimulation.

    Measured: From inclusion to 56 weeks after discharge

  11. C-reactive protein (inflammation)

    Difference in inflammation between groups

    Measured: From inclusion to 56 weeks after discharge

  12. Soluble urokinase plasminogen activator receptor (suPAR) (ng/ml)

    The plasma level of suPAR is a measure of inflammation and can be used to assess the difference in inflammation between groups

    Measured: From inclusion to 56 weeks after discharge

  13. Frequency of physicians' acceptance of suggested changes in medications

    Measured: At inclusion and at 4 weeks after discharge in the FAM group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2017
  2. Study startNov 2016
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03052192
Sponsor's protocol ID
FAM-CPH-cohort
Other IDs
H-16038786, AHH-2016-067 (I-suite 04931)
Acronym
FAM-CPH
Status last verified
Oct 2019
First submitted
5 Jan 2017
Last updated
15 Oct 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 36136804

Questions about this trial

What is this clinical trial studying?

An observational study of Aging and Polypharmacy, run by Hvidovre University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eating validation scheme score (time frame: From inclusion to 4 weeks after discharge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03052192, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in