To evaluate the feasibility of (1) the use of the Beter Voorbereid* application and the study procedures of a randomized controlled trial (finished in June 2019) and (2) evaluating the effectiveness of the *Beter Voorbereid* application on improved…
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) The main study endpoint is on feasibility.
Feasibility of the use of BeterVoorbereid* application will be assessed by
usability questions (Net promotor score and other usability questions; all
patients in the intervention arm) and by semi-structured telephone interviews
(random selection of 20 patients in the intervention arm).
(2) The main study endpoint is effectiveness.
The effectiveness will be evaluates using a physical functioning questionnaire
on several timepoints, until 12 weeks after hospital discharge
Secondary outcome
(1) we explore whether the use of this eHealth app leads to changes in
preoperative lifestyle (i.e. exercise and/or smoking cessation and/or and/or
nutrition) compared to control patients. Feasibility of the study procedures
will be assessed using registration of patient recruitment and participation
and monitoring of data collection.
(2) 'global health', patient satisfaction, global perceived effect, lifestyle
changes, length of hospital stay, postoperative complications
Background summary
The eHealth application *Beter Voorbereid* is a mobile eHealth application that
uses a set of questions to map a patient*s lifestyle risk factors for delayed
postoperative recovery in patients undergoing major surgery. Based on the life
style of the patient, a tailored preoperative lifestyle advise is provided.
Additonal guidance by a physiotherapist will be advised based on the level of
pre-operative physical functioning and/or present medical risk factors.
Study objective
To evaluate the feasibility of (1) the use of the Beter Voorbereid* application
and the study procedures of a randomized controlled trial (finished in June
2019) and (2) evaluating the effectiveness of the *Beter Voorbereid*
application on improved functional recovery after surgery when compared to
control patients.
Study design
(1) Feasibility study (pilot randomized controlled trial) (finished)
(2) Effectiveness study (RCT)
Intervention
Use of an eHealth application for prehabilitation of surgical patients in the
preoperative period. The intervention group is compared to control subjects
receiving usual care.
Study burden and risks
There are minimal risks associated with this study. Patients in the
intervention group may increase their daily activities and/or visit a
physiotherapist. Moreover, all patients included in this study will be followed
until the 12 weeks after hospital discharge, with a minimal set of questions
per time point (4 post-discharge time points with maximum of 10 minutes per
time point to fill in questionnaire).
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Age >= 18 years old
Indication for postoperative hospital stay (minimum of two nights)
One or more lifestyle risk factor
Informed consent
Exclusion criteria
Emergency surgery
Unable to work with the eHealth application
Dutch language inproficiency
No access to a tablet or smartphone
Planned for brain surgery
Less than 7 days between inclusion and surgery
Already participating in intensive pre-operative care pathway (including
exercise program)
Already participating in a conflicting study (to be determined per
participating center)
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL61503.029.18 |
| OMON | NL-OMON28174 |