Preoperative Risk AssessmentPrepTABNCT04160234
Preoperative Risk Assessment in the Elderly
An observational study of Preoperative Risk Assessment, run by RWTH Aachen University at 1 site in Germany.
Trial summary
PrepTAB aims to determine whether elderly patients are able to complete 4 preoperative risk assessment questionnaires within a web-based survey. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Preoperative Risk Assessment
- What is being tested?
- web-based questionnaires
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 22 Nov 2019to Jan 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
Ana Kowark, MD, +4924180-88179, anaesthesiologie@ukaachen.de
Sebastian Ziemann, MD, +4924180-88179, anaesthesiologie@ukaachen.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Preoperative Risk Assessment
- Being tested
- web-based questionnaires
- Keywords
- elderly, surgery, preoperative risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based questionnairesOther
Patients will be asked to complete web-based questionnaires on a tablet computer
| Study group | Role | What they receive |
|---|---|---|
| Elderly patient | Preoperative elderly patients, who are planned for a surgical intervention Receives: Other: web-based questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate
The completion rate of the total number of questions of the web-based questionnaires
Measured: 1 day
Secondary outcomes (8)
Frequency of patient's requests for help to the accompanying next of kin
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
Measured: 1 day
Assessment of the kind of patient's requests for help to the accompanying next of kin
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
Measured: 1 day
Assessment of the kind of patient's requests for help to the study team member
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
Measured: 1 day
Frequency of patient's requests for help to the study team member
The study team member, who is present during the study treatment, will assess the frequency of the patient's requests for help to him
Measured: 1 day
Elapsed time for questionnaire completion
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
Measured: 1 day
Ranking of unanswered questions
We will analyse which questions where not answered by the most patients.
Measured: 1 day
Patient satisfaction
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
Measured: 1 day
Frequency of technical problems
The frequency of technical problems (i.e. internet connection, black screen etc.) will be assessed by the present study team member
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start22 Nov 2019
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Risk AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Kowark, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160234
- Sponsor's protocol ID
- EK 342/19
- Acronym
- PrepTAB
- Status last verified
- Feb 2021
- First submitted
- 8 Nov 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Preoperative Risk Assessment in the Elderly: a Pilot-study
- ClinicalTrials.gov ID
- NCT04160234
- Acronym / sponsor ID
- PrepTAB / EK 342/19
- Conditions
- Preoperative Risk Assessment
- Keywords
- elderly, surgery, preoperative risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PrepTAB aims to determine whether elderly patients are able to complete 4 preoperative risk assessment questionnaires within a web-based survey.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patient | – | Other: web-based questionnairesPreoperative elderly patients, who are planned for a surgical intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web-based questionnairesPatients will be asked to complete web-based questionnaires on a tablet computer | Other | Elderly patient |
Primary outcome
Completion rate
Time frame: 1 day
The completion rate of the total number of questions of the web-based questionnaires
8 secondary outcomes
Frequency of patient's requests for help to the accompanying next of kin
Time frame: 1 day
Assessment of the kind of patient's requests for help to the accompanying next of kin
Time frame: 1 day
Assessment of the kind of patient's requests for help to the study team member
Time frame: 1 day
Frequency of patient's requests for help to the study team member
Time frame: 1 day
Elapsed time for questionnaire completion
Time frame: 1 day
Ranking of unanswered questions
Time frame: 1 day
Patient satisfaction
Time frame: 1 day
Frequency of technical problems
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Risk Assessment, run by RWTH Aachen University 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 5 inclusion and 8 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 10 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Kowark, MD (+49241800, akowark@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2021.