Secondary Prevention of Dug-related Problems Through Digital Health
NCT ID: NCT04841863
Last Updated: 2021-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2021-04-30
2023-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Drug Code Active Patient o DCAP
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.
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.
Standard care
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.
Satndard care
Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care.
Interventions
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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.
Satndard care
Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Ana Juanes
Doctor
Principal Investigators
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Laia López Vinardell
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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IIBSP-COD-2019-46
Identifier Type: -
Identifier Source: org_study_id
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