Preoperative Risk Assessment in the Elderly (PrepTAB)

February 5, 2021 updated by: Ana Kowark, RWTH Aachen University

Web-based Preoperative Risk Assessment in the Elderly: a Pilot-study

PrepTAB aims to determine whether elderly patients are able to complete 4 preoperative risk assessment questionnaires within a web-based survey.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Elderly patients are the most rapidly increasing group among surgical admissions. They are prone to a higher risk, because of predisposing risk factors. A comprehensive preoperative risk assessment is recommended by the European Society of Anaesthesiologists guideline, but time-consuming and usually not performed at present. A telemedical approach would enable an out-of hospital risk assessment before hospital admission and provide important information without the need for additional in-hospital resources. The feasibility of the completion of a web-based questionnaire by elderly patients, within a controlled in-hospital setting is required, as a base for a telemedical approach.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • Recruiting
        • Department of Anesthesiology, University Hospital Aachen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Kowark, MD
        • Sub-Investigator:
          • Mark Coburn, Prof.
        • Sub-Investigator:
          • Sebastian Ziemann, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A convenient sample of patients, meeting all inclusion and none exclusion criteria, will be enrolled in the study. The patients will be recruited from the anaesthesia ambulance in the University hospital RWTH Aachen, where they have an appointment with the anaesthetist before their planned surgery.

Description

Inclusion Criteria:

  • Legally competent patients
  • Written informed consent
  • Age ≥ 65, male, female, diverse
  • Multimorbid patients (≥ 2 comorbidities (according to the Charlson Comorbidity Index)
  • Major elective surgery (such as total abdominal hysterectomy, endoscopic resection of prostate, lumbar discectomy, thyroidectomy, total joint replacement, lung operations, colon resection, radical neck dissection etc.)

Exclusion Criteria:

  • Blind or deaf patients
  • Patient/ Proxy not able to use electronic devices e.g. computer, tablet or smart phone
  • Non-fluency in local language
  • Alcohol and/ or drugs abuse
  • Ambulatory surgery
  • Repeated surgery, with previous participation
  • Patients with severe neurological or psychiatric disorder
  • Refusal of study participation by the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Elderly patient
Preoperative elderly patients, who are planned for a surgical intervention
Other: web-based questionnaires
Patients will be asked to complete web-based questionnaires on a tablet computer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Completion rate
Time Frame: 1 day
The completion rate of the total number of questions of the web-based questionnaires
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of patient's requests for help to the accompanying next of kin
Time Frame: 1 day
The study team member, who is present during the study treatment, will assess the frequency of the patient's requests for help to the accompanying next of kin
1 day
Assessment of the kind of patient's requests for help to the accompanying next of kin
Time Frame: 1 day
The study team member, who is present during the study treatment, will assess the kind of the patient's requests for help to the accompanying next of kin, divided into: technical request or request regarding the content of the web-based questions
1 day
Assessment of the kind of patient's requests for help to the study team member
Time Frame: 1 day
The study team member, who is present during the study treatment, will assess the kind of the patient's requests for help to himself, divided into: technical request or request regarding the content of the web-based questions
1 day
Frequency of patient's requests for help to the study team member
Time Frame: 1 day
The study team member, who is present during the study treatment, will assess the frequency of the patient's requests for help to him
1 day
Elapsed time for questionnaire completion
Time Frame: 1 day
The survey software will automatically count the elapsed time for completion of the questionnaires. The time will start in the moment, when the patient accesses the website and it will end when he presses the finish button
1 day
Ranking of unanswered questions
Time Frame: 1 day
We will analyse which questions where not answered by the most patients.
1 day
Patient satisfaction
Time Frame: 1 day
Analysis of patient satisfaction about the web-based questionnaires. A paper-based satisfaction questionnaire is provided to the patient after the completion of the web-based survey. The satisfaction questionnaire will consist of a 5-point Likert scale. It will consist of the items: Strongly disagree; Disagree; Neither agree nor disagree; Agree; Strongly agree
1 day
Frequency of technical problems
Time Frame: 1 day
The frequency of technical problems (i.e. internet connection, black screen etc.) will be assessed by the present study team member
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RWTH Aachen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EK 342/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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