Secondary Prevention of Dug-related Problems Through Digital Health

NCT04841863 | Unknown

• 1 other identifier: IIBSP-COD-2019-46
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug-Related Problems

Keywords

DRP; Digital Health

Outcome Measures

Primary Outcomes (2)

• Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.

  Change in clinical impact during the follow-up time will be evaluated in terms of number of readmissions, number of revisits and quality of life (based on the result obtained in the EQ-5D-3L51 questionnaire)

  Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)

• Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.

  Change in clinical impact during the follow-up time will be evaluated in terms of number of readmissions, number of revisits and quality of life (based on the result obtained in the EQ-5D-3L51 questionnaire)

  Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)

Secondary Outcomes (11)

• Identify, classify, and quantify DRP that cause urgent care in a tertiary hospital in this patient population.

  Baseline

• Identify risk factors for ED visits related to DRP

  Baseline

• Identify which groups of drugs are more frequently associated to DRP

  Baseline

• Change in the patient therapeutic adherence

  Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)

• Change in the patient therapeutic adherence

  Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)

Study Arms (2)

Drug Code Active Patient o DCAP

ACTIVE COMPARATOR

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. Patients will receive follow-up by videoconference 48 hours after discharge and in the phase II, at 6 and 12 months after discharge.

Device: MyPlan digital health platform

Standard care

PLACEBO COMPARATOR

Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care. Patients will receive follow-up by videoconference 48 hours after discharge and in the phase II, at 6 and 12 months after discharge.

Other: Satndard care

Interventions

MyPlan digital health platform DEVICE

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.

Drug Code Active Patient o DCAP

Satndard care OTHER

Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care.

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years.
• Visit ED for a DRP caused bu a drug of the ATC groups A, B, C or N.
• Be independent for activities of daily living (equivalent to Barthel 100).
• Have a Chalson Comorbidity Index 2 \<= 3.
• Not present cognitive impairment.
• Be directly responsible for pharmacotherapy.
• Have a mobile device compatible with the MyPlan mobile application and access to Wi-Fi or mobile data, enabling the use of the technology platform from home.

You may not qualify if:

• Important language barrier.
• Impossibility of carrying out the necessary questionnaires or interviews defined in the methods of this study.
• Mental pathology that makes the autonomous use of technology impossible or that represents a safety problem for the patient according to clinical criteria.
• Patients not residing in the territory who cannot be followed-up later.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

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Study Officials

• Laia López Vinardell

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Juanes Borrego, Doctor

CONTACT

932 91 90 00; ajuanes@santpau.cat

Jesús Ruiz Ramos, Doctor

CONTACT

932 91 90 00; jruiz@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: April 12, 2021
• Study Start: April 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: April 1, 2023
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be avaliable for monitor during the whole study period
• Access Criteria: All data may be analysed and revised during the whole study period by the monitor and investigators

Locations

ES (1)