NCT04160234

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

November 22, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

November 8, 2019

Last Update Submit

February 5, 2021

Conditions

Keywords

elderlysurgerypreoperative risk

Outcome Measures

Primary Outcomes (1)

  • Completion rate

    The completion rate of the total number of questions of the web-based questionnaires

    1 day

Secondary Outcomes (8)

  • Frequency of 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

    1 day

  • Assessment of the kind of patient's requests for help to the study team member

    1 day

  • Frequency of patient's requests for help to the study team member

    1 day

  • Elapsed time for questionnaire completion

    1 day

  • +3 more secondary outcomes

Study Arms (1)

Elderly patient

Preoperative elderly patients, who are planned for a surgical intervention

Other: web-based questionnaires

Interventions

Patients will be asked to complete web-based questionnaires on a tablet computer

Elderly patient

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Central Study Contacts

Ana Kowark, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 12, 2019

Study Start

November 22, 2019

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations