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Perioperative CarePeriAgeNCT03325413

Improvement of Perioperative Care of Elderly Patients

A study testing Systematic inclusion of family members, Preoperative information and Physical and breathing exercises in people with Perioperative Care, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The focus of this study is the development of a perioperative treatment concept for elderly patients, based on individual necessities and risk factors, aiming to improve patient outcome. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Perioperative Care
What is being tested?
Systematic inclusion of family members, Preoperative information and Physical and breathing exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
1 siteGermany
Study dates
1 Nov 2017to 14 May 2020
Phase
Interventional
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age >64 years
  • Written informed patients consent
  • forthcoming elective surgery
  • Time interval from inclusion to appointed surgery at least 5 days

Who cannot join

  • Refusal of consent
  • Illiteracy
  • Poor knowledge ofGerman language
  • Mental disability
  • Vision handicap (not corrected)
  • Hearing handicap (not corrected)
Show all 15Show fewer
  • Benzodiazepine abuse
  • Drug/ substance abuse
  • Psychosis
  • Parkinson disease
  • Emergency surgery
  • Planned postoperative ICU treatment
  • Planned inpatient stay 1 night
  • Cerebral surgery
  • Ophthalmological surgery

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf (UKE)

    Hamburg

Other trials in Germany

About this study

The focus of this study is the development of a perioperative treatment concept for elderly patients, based on individual necessities and risk factors, aiming to improve patient outcome. The planned interventions include preoperative screening for malnutrition, frailty and uncalled-for long-term medication, if required followed by early prophylaxis and treatment of these risk factors, prior to or during surgery.

Read the detailed description

In Germany every second inpatient surgical intervention is performed on patients aged 60 years and above. These patients often offer an extensive set of risk factors such as frailty, malnutrition, poor physical fitness and multi-morbidity that may in turn lead to longer hospitalizations and decline of health and functional status after surgery. An age-related increase in postoperative complications, such as postoperative cognitive dysfunction (POCD) and delirium is associated with a higher rate of postoperative morbidity, mortality and longer hospitalization.

Early detection of risk factors and implementation of prophylactic measures is important to reduce postoperative complications and improve clinical outcomes in elderly patients. The aim of our study is to develop and verify a protocol - which allows for a systematic evaluation of risk factors and the implementation of prophylactic or therapeutic measures in order to optimize the postoperative outcome. The feasibility of our protocol will be verified in clinical practice by systematic process evaluations.

Being tested
Systematic inclusion of family members, Preoperative information, Physical and breathing exercises, Dietary supplements, Evaluation of long-term medication
Keywords
Perioperative geriatric care, Geriatric assessment, Postoperative cognitive dysfunction, POCD, Frailty, Depression, Physical fitness, Geriatric anesthesia, IADL, Postoperative functional status, Quality of life
Medical subject headings
Postoperative Cognitive Complications, Frailty, Depression

What participants receive

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

  • Systematic inclusion of family membersBehavioural

    Systematic inclusion of family members/ reference person in the perioperative process

  • Preoperative informationBehavioural

    Detailed preoperative information about delirium prevention and procedures

  • Physical and breathing exercisesBehavioural

    Preoperative execution of physical and breathing exercises if necessary

  • Dietary supplementsDietary supplement

    Dietary supplements if necessary

  • Evaluation of long-term medicationOther

    Avoidance of unsuitable drugs for elderly if possible

  • Regional anesthesiaProcedure or surgery

    Regional anesthesia whenever possible

  • Personal aidsOther

    Personal orientation aids until anesthesia induction

  • Temperature managementDevice

    Perioperative warming

  • NeurmonitoringDevice

    Using Bispectral index (BIS) to measure the depth of anesthesia

  • Pain catheterProcedure or surgery

    A pain catheter will be used as postoperative pain therapy if possible

Study groups in NCT03325413
Study groupRoleWhat they receive
ControlNo interventionUsual care with assessment only (no study-related intervention)
ImplementationOtherImplementation of intervention measures
Receives: Behavioral: Systematic inclusion of family members; Behavioral: Preoperative information; Behavioral: Physical and breathing exercises; Dietary Supplement: Dietary supplements; Other: Evaluation of long-term medication; Procedure: Regional anesthesia; Other: Personal aids; Device: Temperature management; Device: Neurmonitoring; Procedure: Pain catheter
Full-scale interventionOtherNot described
Receives: Behavioral: Systematic inclusion of family members; Behavioral: Preoperative information; Behavioral: Physical and breathing exercises; Dietary Supplement: Dietary supplements; Other: Evaluation of long-term medication; Procedure: Regional anesthesia; Other: Personal aids; Device: Temperature management; Device: Neurmonitoring; Procedure: Pain catheter

What is being measured

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

  1. Functional abilities

    Change in functional abilities from baseline, evaluated by Instrumental Activities of Daily Living (IADL) score

    Measured: Evaluation preoperatively, 1 month, 6 months after surgery

Secondary outcomes (6)

  1. Cognitive impairment

    DemTect: cognitive screening instrument, sensitive to the early symptoms of dementia

    Measured: Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery

  2. Attention and task switching

    The Trail Making Test A\&B (TMT A\&B): a neuropsychological test of visual attention and task alternation

    Measured: Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery

  3. Attentional capabilities

    TAP Alertness: a computerized, standardized neuropsychological test for attentional performance.

    Measured: Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery

  4. Health related quality of life

    Measured by a 12-item short-form (SF-12) Health Survey

    Measured: Evaluation preoperatively, 1 month, 6 months after surgery

  5. Hospital length of stay

    Day of admission until day of discharge

    Measured: 1 month

  6. Postoperative complications

    Incidence of postoperative complications

    Measured: Evaluation evaluation of complications at 2-5 days, 1 month, 6 months after surgery

Timeline

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

  1. First posted30 Oct 2017
  2. Study start1 Nov 2017
  3. Primary completion14 May 2020
  4. Study completion14 May 2020

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Sequential
Model description
The study has 3 arms with patients allocated to them in a fixed chronological order. For six months, patients will be recruited for the control arm. In this arm, participants receive usual care without any additional intervention initiated by the study. After finishing recruitment for the control arm, patients will be recruited for the implementation arm for six months. In this arm, stepwise implementation of the study interventions begins with the possibility of flexibly adapting them to the specific conditions. After finishing recruitment for the implementation arm, patients will be recruited for the full-scale intervention arm for six months. In this arm, all study interventions will be utilized.
Masking
None (open label)
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03325413
Sponsor's protocol ID
PV5596
Other IDs
01VSF16057
Acronym
PeriAge
Status last verified
May 2021
First submitted
2 Oct 2017
Last updated
18 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lebherz L, Olotu C, Koch B, Kiefmann R, Harter M, Kriston L. Evaluating the implementation process of a multicomponent perioperative intervention for prevention of postoperative functional decline in geriatric patients: a qualitative study. BMJ Open. 2025 Dec 18;15(12):e104460. doi: 10.1136/bmjopen-2025-104460.

    PubMed 41412625

  • Olotu C, Lebherz L, Mende A, Hempel C, Philipp R, Schroeter J, Plumer L, Koch B, Harter M, Zollner C, Kriston L, Kiefmann R. Feasibility and effectiveness of an evidence-based intervention bundle to improve peri-operative care of older adults: A quality improvement study. Eur J Anaesthesiol Intensive Care. 2024 Jul 4;3(4):e0055. doi: 10.1097/EA9.0000000000000055. eCollection 2024 Aug.

    PubMed 39917250

  • Olotu C, Lebherz L, Harter M, Mende A, Plumer L, Goetz AE, Zollner C, Kriston L, Kiefmann R. Improvement of perioperative care of the elderly patient (PeriAge): protocol of a controlled interventional feasibility study. BMJ Open. 2019 Nov 24;9(11):e031837. doi: 10.1136/bmjopen-2019-031837.

    PubMed 31767591

Questions about this trial

What is this clinical trial studying?

A study testing Systematic inclusion of family members, Preoperative information and Physical and breathing exercises in people with Perioperative Care, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

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 4 inclusion and 15 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: finished, as of the sponsor's last update on 18 May 2021. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Functional abilities (time frame: Evaluation preoperatively, 1 month, 6 months after surgery). 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 NCT03325413, which also lists 3 linked publications.

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 18 May 2021.

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