The main objective of this study is to investigate whether quality of life can be improved by personalised and timed guidance, and/or use of the peer-support platform; as provided by a patient-centred mobile application.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Bladder and bladder neck disorders (excl calculi)
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life
Secondary outcome
Postoperative data < 30 days
• Length of hospital stay: continuous variable, measured in days
• Complications - major: ordinal variable, Clavien Dindo Classification of
surgical complications (III-V)
• Complications - minor: ordinal variable, Clavien Dindo Classification of
surgical complications (I-II)
• Overall morbidity within the first 30 days postoperative
• Reoperations: dichotomous variable, Yes/No
• Readmission <30 days: dichotomous variable, Yes/No
• In-hospital mortality: dichotomous variable, Yes/No
• Number of outpatients visits: continuous variable,
• Self-reported problems related to a stoma: nominal ordinal
Postoperative data < 90 days
• Complications - major: ordinal variable, Clavien Dindo Classification of
surgical complications (III-V)
• Complications - minor: ordinal variable, Clavien Dindo Classification of
surgical complications (I-II)
• Overall morbidity within the first 90 days postoperative
• Reoperations: dichotomous variable, Yes/No
• Readmission <90 days: dichotomous variable, Yes/No
• Number of outpatients visits: continuous variable,
• Self-reported problems related to a stoma: nominal ordinal
Postoperative data < 180 days
• Complications - major: ordinal variable, Clavien Dindo Classification of
surgical complications (III-V)
• Complications - minor: ordinal variable, Clavien Dindo Classification of
surgical complications (I-II)
• Overall morbidity within the first 180 days postoperative
• Reoperations: dichotomous variable, Yes/No
• Readmission <180 days: dichotomous variable, Yes/No
• Number of outpatients visits: continuous variable,
• Self-reported problems related to a stoma: nominal ordinal
Postoperative data < 1 year
• Complications - major: ordinal variable, Clavien Dindo Classification of
surgical complications (III-V)
• Complications - minor: ordinal variable, Clavien Dindo Classification of
surgical complications (I-II)
• Overall morbidity within the first 180 days postoperative
• Reoperations: dichotomous variable, Yes/No
• Readmission <180 days: dichotomous variable, Yes/No
• Number of outpatients visits: continuous variable,
• Self-reported problems related to a stoma: nominal ordinal
PROMS
• General quality of life: measured with the WHOQoL: questionnaire consisting
of ordinal variables
• Stoma quality of life: measured with the Stoma-QoL questionnaire consisting
of ordinal variables
• Disabillity: measured with the WHODAS2 questionnaire consisting of ordinal
variables
• Psychosocial adaption measured with the OAI-23 questionnaire consisting of
ordinal variables
• Patient satisfaction questionnaire: measured with a self-developed patient
satisfaction questionnaire consisting of ordinal variables
Background summary
Having a stoma often has a negative impact on the self-image and daily
functioning of the patient, resulting in a reduced quality of life. Patient
education and -guidance is of crucial importance for patients having a stoma.
Patients have to adapt to and cope with the new situation, which might be
difficult and result in insecurities. Insecurities are reported to lead to a
variety of psychosocial problems. Self-efficacy is known to be associated with
a reduction of these psychosocial problems and stoma-related morbidities.
Study objective
The main objective of this study is to investigate whether quality of life can
be improved by personalised and timed guidance, and/or use of the peer-support
platform; as provided by a patient-centred mobile application.
Study design
Multicenter double blinded randomized controlled trial, with a control group
Intervention
A mobile applicaton offering personalised and timed guidance and information
-such as operation-specific information and the associated care path. Also,
they have access to a peer-support platform. Based on the date of surgery and
discharge, a timeline is generated within the application. Information becomes
available when it's relevant for the patient. Information is brought to the
user's attention with pushnotifications.
Besides informing patients and motivating them to participate in their own care
pathway, the app has a function in registering study outcomes,
Study burden and risks
Both the control group as well as the intervention group will receive care
conform the current standard and use a mobile application. The only difference
is the personalised and timed information and peer-contact within the
intervention group, therefore no additional risks are associated with
participation in this trial. Burden of participation is restricted to the
completion of five different questionnaires
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Individuals scheduled for elective surgery ending in urostomy.
Adults aged >=18 years
Possession of a smartphone operated with iOS 9 and up or Android 8.0 and up
Exclusion criteria
Patients with a Karnofsky score <=40
Incompetence of understanding the Dutch language
Visual impairment, unless well corrected with visual aids
Physical disabilities limiting the use of a mobile application, such as
Parkinson*s disease
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78192.018.21 |