NCT04841863

Secondary Prevention of Dug-related Problems Through Digital Health

Secondary Prevention of Dug-related Problems Through Patient Empowerment Through Digital Health

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical impact of a program for the secondary prevention of drug-realted problems (DRP) focused on the patient empowerment through Digital Health in patients who visit the Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCiSP) for a health problem related to medication in terms of readmissions, revisits and quality of life.

Detailed description

After being infomed about the estudy and potential risks, all patients who meet the eligibility requirements and giving written informed consent, will be randomized. The project is structured in two consecutive phases. 1. st Phase: 3-month randomized pilot study. Patients will be randomized with a 1:1 distribution to be included in the Drug Code Active Patient or DCAP (intervention group) or to receive usual care (control group). The pilot study will confirm whether the proposed methodology is feasible to implement it on a large scale, as well as providing the information necessary to calculate the sample of patients according to the main objective of the study. 2. nd Phase: Randomized clinical trial lasting 18 months (6 of which will be recruitment and 12 months follow-up) following the methodology described for the pilot in a larger sample of patients until the calculated sample size is achieved.

Conditions

• Drug-Related Problems

Interventions

Type	Name	Description
DEVICE	MyPlan digital health platform	Inclusion in the active group involves the use of MyPlan digital health tool that aims to improve clinical-patient communication, enahnce patient empowerment, improve early detection of side effects and allows professionals to individualize interventions.
OTHER	Satndard care	Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care.

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-10-01
• Completion: 2023-04-01
• First posted: 2021-04-12
• Last updated: 2021-04-12

Locations

1 site across 1 country: Spain