The primary study objective is the assessment of changes in the stress exhibited by patients using the SAM solution versus those in the control group until the surgical procedure.
Source
Brief title
Condition
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoint will be the percentage change between the baseline
stress VAS score and the VAS score measure before surgery.
Secondary outcome
Secondary study endpoints include:
* The percentage change in stress VAS scores considering the different phases
of the patient journey (i.e., from baseline to hospital admission, from
hospital admission to surgery, from surgery to hospital discharge, and from
hospital discharge to the 14-day post-surgery visit).
* The percentage change in pain VAS scores considering the different phases of
the patient journey (i.e., from baseline to hospital admission, from hospital
admission to surgery, from surgery to hospital discharge, and from hospital
discharge to the 14-day post-surgery visit).
* The difference between study groups in the mean change of empowerment scores
measured according to the Patient Activation Measure® (PAM-13®) within the
different phases of the patient journey (i.e., from baseline to hospital
admission, from hospital admission to surgery, from surgery to hospital
discharge, and from hospital discharge to the 14-day post-surgery visit).
* The difference between study groups in the change of quality-of-life scores
measured according to the EuroQoL-5D-3L (EQ-5D-3L) (or the EQ-5D-Y for children
and adolescents), from baseline to the 14-day post-surgery visit.
* Differences between study groups in the frequencies of patients with wound
healing problems, including the categorisation of these problems, from the
surgery to the 14-day post-surgery visit.
* Correlations of stress levels measured on the VAS with stress levels
identified by the wristband and the SAM's voice tool in patients using the SAM
solution in all measurements performed throughout the study.
* The usability and satisfaction with the SAM solution reported in the
intervention group at hospital admission, hospital discharge, and the 14-day
post-surgery visit according to standard questions for patients and healthcare
professionals, a patient subjective 1-10 satisfaction scale and the Net
Promoter ScoreSM calculation.
Background summary
Based on the fact that stress can cause detriments in the quality of life of
patients facing surgery and have a negative impact on the different stages of
the patient journey, we developed a technological solution named SAM to manage
surgery-related stress. It was conceived as a comprehensive tool to monitor and
manage the stress exhibited by patients, as well as being also useful for both
healthcare professionals and caregivers. To do so, the SAM's mobile application
includes different tools to monitor stress and suggestions to manage it,
including the communication of patients with their healthcare professionals and
caregivers. Furthermore, the SAM solution includes a website specifically
designed for healthcare professionals that enable them to include basic patient
data, follow-up patients, and personalise informative contents that may be
useful for both patients and caregivers.
The technological solution needs to adapt to different personal profiles, which
include different contexts, preferences, circumstances, age, cultural
background, literacy level, and digital competences. Therefore, the patients to
be included in this clinical trial need to be barely selected, including both
adults and children.
We hypothesise that the use of the SAM solution may contribute to reducing the
stress caused by surgeries while empowering patients and supporting them until
their prompt recovery and return to normal life. However, it was not previously
tested in the target population and, therefore, it is still a hypothesis that
we intend to assess in this randomised controlled trial, in which patients
using the SAM solution will be compared with those followed up according to
routine clinical practice.
Study objective
The primary study objective is the assessment of changes in the stress
exhibited by patients using the SAM solution versus those in the control group
until the surgical procedure.
Study design
a multicentre, open-label, randomised, parallel-group clinical trial
Study burden and risks
It is expected that patients within the SAM solution group have less stress and
more empowerment, but we cannot assure it. As the use of the SAM solution is a
non-drug and non-invasive intervention, it should entail no risk for the
patient
Rambla del Celler 117-119
Sant Cugat del Valles Barcelona 08172
ES
Rambla del Celler 117-119
Sant Cugat del Valles Barcelona 08172
ES
Listed location countries
Age
Inclusion criteria
* Adults (with the exception of paediatric Hospital Sant Joan de Déu: children
*8 years old).
* Planned surgery of the following selected types:
* Coronary bypass surgery
* Orthognathic surgery
* Idiopathic scoliosis without mental impairment and hip surgery
* Maxillofacial surgery
* Hip and knee replacement
* Prostate, kidney and bladder cancer surgery
* Cardiac valve replacement, possibly in combination with coronary bypass
surgery
* Planned surgery 2 to 4 weeks after the moment of inclusion/signing the
informed consent.
* Signed informed consent
Exclusion criteria
* Dementia.
* Any other psychiatric disorder.
* Pregnant women.
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 | NL78536.068.21 |