Impact of mHealth in Heart Transplant Management

Not Applicable

• Conditions: Heart Transplant

• Registration Number: NCT02554578
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

The purpose of this study is to improve medication adherence, engagement and support to heart transplant patients through implementation of a new clinical care programme conducted by the clinical pharmacy service in cooperation with the heart transplant team and supported by mobile health (mHealth).

Detailed Description

Non-adherence to immunosuppressive medications generally ranges from 20-40% and is associated with acute rejection episodes and graft loss. Many solid organ transplant centres have incorporated transplant pharmacists into the multidisciplinary transplant clinical team focused on improving outcomes and safety associated with drug therapy.

Mobile technology has undergone rapid advances in the past several years and the use of mHealth in pharmaceutical care is changing pharmacy practice. Several published reports have identified general mobile applications suited for improve adherence. But evidence supporting the benefits in clinical practice is limited.

This study expects to analyse the potential of mHealth to improve medication adherence and heart transplant patient management in real clinical practice.

The investigators asses a new multidisciplinary follow-up programme in heart transplant recipients supported by mobile health (mHealth) with the aim to improve medication adherence, prevent drug related problems and improve patient clinical outcomes.

Study Timeline

• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Study Start: 2015-10
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-22
• Last Update Posted: 2016-08-23
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• Heart transplant patients ≥ 18 years of age
• Give informed consent.
• Be able to use a mobile device (smartphone).
• Sign a confidentiality agreement (interventional group).

Exclusion Criteria

• Do not meet all the inclusion criteria.
• Non-available to receive a minimum of one-year clinical follow-up by the heart transplant unit.
• Suffer severe mental disorders, other mental pathologies or conditions that can be a barrier to use the mobile application

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medication adherence measured on validated scales and questionnaires	6 months	Change From Baseline in Medication Adherence on the Simplified Medication Adherence Questionnaire (SMAQ)