Empowering patients by professional STress Avoidance and Recovery Services using the Stress Adaptative Manager (SAM) solution

Empowering patients by professional STress Avoidance and Recovery Services using the Stress Adaptative Manager (SAM) solution - STARS-SAM

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49885

Enrollment

Registered

2021-10-27

Start date

2021-12-02

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life Stress

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: * Dementia. * Any other psychiatric disorder. * Pregnant women.

Design outcomes

Primary

Measure	Time frame
The primary study endpoint will be the percentage change between the baseline stress VAS score and the VAS score measure before surgery.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results