ANZCTR - Registration

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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cystectomy

readmission rate

Condition category

Condition code

Renal and Urogenital

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]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Number of prevented readmissions due to complication after radical cystectomy, assessed by direct feedback (vital signs) from patients in the APP.

Timepoint [1]

within 90 days post cystectomy

Secondary outcome [1]

usefulness of APP evaluated by patients with visual analogue score

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Switzerland

State/province [1]

Lucerne

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Urologie St. Anna

Address [1]

St. Anna Strasse 32
6006 Luzern

Country [1]

Switzerland

Primary sponsor type

Other

Name

Urologie St. Anna

Address

St. Anna Strasse 32
6006 Luzern

Country

Switzerland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not required

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Dr Philipp Huber

Address

Urologie St. Anna
St. Anna Strasse 32
6006 Luzern

Country

Switzerland

Phone

+41414104170

Fax

[email protected]

Contact person for public queries

Name

Philipp Huber

Address

Urologie St. Anna
St. Anna Strasse 32
6006 Luzern

Country

Switzerland

Phone

+41414104170

Fax

[email protected]

Contact person for scientific queries

Name

Philipp Huber

Address

Urologie St. Anna
St. Anna Strasse 32
6006 Luzern

Country

Switzerland

Phone

+41414104170

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Intensified 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.	2020	https://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.

Trial Review

Documents added manually

Documents added automatically