Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001741178
Ethics application status
Not required
Date submitted
16/09/2019
Date registered
9/12/2019
Date last updated
9/06/2021
Date data sharing statement initially provided
9/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of an APP for patients after radical cystectomy
Scientific title
Prospective analysis of standardized digital communication with newly developed APP for patients after radical cystectomy with aim of reducing re-hospitalization rates
Secondary ID [1] 299293 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cystectomy 314420 0
readmission rate 314421 0
Condition category
Condition code
Renal and Urogenital 312764 312764 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
As part of this study an APP has been developed and will be provided for free to study patients after radical cystectomy. Aim of this digital cell phone based APP is to intensify and standardize communication between patients undergoing radical cystectomy and their surgeon. Since evaluation of the APP’s usefulness is part of this study only patients agreeing to participate in this study are provided with the APP. All other patients will be clinically followed on a regulare base, so no disadvantage exist when patients do not participate or can not use the APP.

Documentation of vital signs by patients during 90 days postoperatively is requested twice a week in first month, afterwards once per week. Vital signs documented are body weight, body temperature, fluid intake, total amount of urine production, defecation, pain score, nausea (yes/no). With those basic vital signs deviations of regular reconvalescence after surgery can be detected (e.g. nausea in combination of decreased urine produced as sign for acidosis). The APP reminds patients to document their data in intervals as described above. Patient's adherence will be evaluated at the end of 90 days. Also during the study periode surgeons are capable of intervene by calling patients in any case of deviation from normal status (e.g. if fever is documented).
Finally, the aim also is the evaluation of the APP's potential to reduce readmission rates in most vulnerable phase 90 days post surgery after discharge from hospital.
Intervention code [1] 315568 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321388 0
Number of prevented readmissions due to complication after radical cystectomy, assessed by direct feedback (vital signs) from patients in the APP.
Timepoint [1] 321388 0
within 90 days post cystectomy
Secondary outcome [1] 374844 0
usefulness of APP evaluated by patients with visual analogue score
Timepoint [1] 374844 0
at 90 days post surgery

Eligibility
Key inclusion criteria
All patients undergoing radical cystectomy at our institution.
Cell phone with technical requirements for developed APP.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not willing or not able to use the APP.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
18
Final
Recruitment outside Australia
Country [1] 21859 0
Switzerland
State/province [1] 21859 0
Lucerne

Funding & Sponsors
Funding source category [1] 303818 0
Other
Name [1] 303818 0
Urologie St. Anna
Country [1] 303818 0
Switzerland
Primary sponsor type
Other
Name
Urologie St. Anna
Address
St. Anna Strasse 32
6006 Luzern
Country
Switzerland
Secondary sponsor category [1] 303942 0
None
Name [1] 303942 0
Address [1] 303942 0
Country [1] 303942 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 304332 0
Ethics committee address [1] 304332 0
Ethics committee country [1] 304332 0
Date submitted for ethics approval [1] 304332 0
Approval date [1] 304332 0
Ethics approval number [1] 304332 0

Summary
Brief summary
Intervention and study purpose:
By intensified communication between patient and involved surgeon imminent complications after major surgery can be detected at an early stage and therefore prevented by early interventions. An APP simplifies communication between those two parties and provides a simple platform for record basic vital signs.
Study hypothesis: Patient's self monitoring and communication with involved surgeon help to detect potential deviations from regular reconvalescence after major surgery (e.g. radical cystectomy).
Trial website
Trial related presentations / publications
Public notes
No ethical approval necessary for evaluating patients postoperative vital signs by an APP, since these data are evaluated in clinical follow-ups on a regular base.

Contacts
Principal investigator
Name 96574 0
Dr Philipp Huber
Address 96574 0
Urologie St. Anna
St. Anna Strasse 32
6006 Luzern
Country 96574 0
Switzerland
Phone 96574 0
+41414104170
Fax 96574 0
Email 96574 0
[email protected]
Contact person for public queries
Name 96575 0
Dr Philipp Huber
Address 96575 0
Urologie St. Anna
St. Anna Strasse 32
6006 Luzern
Country 96575 0
Switzerland
Phone 96575 0
+41414104170
Fax 96575 0
Email 96575 0
[email protected]
Contact person for scientific queries
Name 96576 0
Dr Philipp Huber
Address 96576 0
Urologie St. Anna
St. Anna Strasse 32
6006 Luzern
Country 96576 0
Switzerland
Phone 96576 0
+41414104170
Fax 96576 0
Email 96576 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patients data will be handled the same as in clinical follow-up in outclinic patients where providing data is not usually done.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIntensified and Standardized Digital Communication with Cystectomy Patients as a Potentially Simple and Effective Modality for Early Detection of Postoperative Complications: Results from a Pilot Study.2020https://dx.doi.org/10.1016/j.euros.2020.08.005
N.B. These documents automatically identified may not have been verified by the study sponsor.