The main objective of this study is to investigate whether access to a peer support platform, age-dependent information provision and games in a smartphone application increases self-reported quality of life, for children receiving a stoma.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome of this study is Quality of life.
Secondary outcome
Secondary outcomes are knowledge retention, patient satisfaction, patient
skills and ability to take care of their stoma, digital literacy.
Background summary
Peer support, patient education and guidance are of crucial importance for
children undergoing surgery for 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. Peer
support helps to cope with the new situation and insecurities. Self-efficacy is
known to be associated with a reduction of psychosocial problems and
stoma-related morbidities.
Study objective
The main objective of this study is to investigate whether access to a peer
support platform, age-dependent information provision and games in a smartphone
application increases self-reported quality of life, for children receiving a
stoma.
Study design
Multicentre randomized controlled trial
Intervention
The intervention group will be asked to install the mobile application and will
be provided an access code to enter the application. The application will give
the participants in the intervention group access to a peer support platform,
age dependent information provision, serious games, quizzes and built-in
questionnaires.
Study burden and risks
The only difference is the use of the mobile application; therefore, no
additional risks are associated with participation in this trial. In the
intervention group the burden of participation is restricted to the
pushed-messages with information to improve self-efficacy and to register the
progress of self-care or outcomes in the app. Both groups are asked to fill out
several questionnaires.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Children between 6 and 18 years old receiving surgery for the creation of a
ileostomy, colostomy, or continent urostomy.
Exclusion criteria
No access to mobile device (smartphone or tablet)
Insufficient understanding of the Dutch language
Incapability to use a mobile device due to physical disabilities
Design
Recruitment
Medical products/devices used
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 | NL81685.018.22 |