No registrations found.
ID
Source
Brief title
Health condition
Ileostomy and colostomy
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life
Secondary outcome
Postoperative data < 30 days
Length of hospital stay
Overall morbidity < 30 days
Complications - major
Complications – minor
Reoperations
Readmission <30 days
In-hospital mortality
Number of outpatients visits
Self-reported problems related to a stoma
Postoperative data < 90 days
Overall morbidity < 90 days
Complications - major
Complications – minor
Reoperations
Readmission <90 days
Number of outpatients visits
Self-reported problems related to a stoma
Postoperative data < 180 days
Overall morbidity < 180 days
Complications - major
Complications – minor
Reoperations
Readmission <180 days
Number of outpatients visits
Self-reported problems related to a stoma
Postoperative data < 1 year
Overall morbidity < 1year
Complications – major
Complications – minor
Reoperations
Readmission <1year
Number of outpatients visits
Self-reported problems related to a stoma
PROMS
General quality of life
Stoma quality of life
Disabillity
Psychosocial adaption
Patient satisfaction
Background summary
Patient education and guidance is of crucial importance for patients having a stoma. Patients have to adapt to the new situation and coping with a stoma might be difficult, resulting 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. The main objective of this study is to investigate whether self-reported quality of life can be enhanced by offering a personalised and timed guidance in a patient-centred mobile application.
Study objective
Patients supported by the intervention version of the app will report a significantly higher quality of life than cancer patients having a stoma who are supported by the control version of the app.
Study design
T0: Installation of the appliction after informed consent
T1: 2 weeks after surgery;
T2: 1 month after surgery;
T3: 3 months after surgery;
T4: 6 months after surgery;
T5: 12 months after surgery
Intervention
Personalized and timed information and guidance in the Stoma-APPtimize application
Inclusion criteria
- Individuals scheduled for elective or emergency colorectal surgery, ending in
o ileostomy
o colostomy
- 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
IPD sharing statement
Plan description
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 |
|---|---|
| NTR-new | NL8895 |
| Other | METC AMC : 75119 |