Impact of mHealth in Heart Transplant Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness Improving Medication Adherence in Heart Transplant Management

Conditions
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Heart Transplant

Intervention / Treatment
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* Other: Multidisciplinary follow-up programme supported by mHealth


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmaceutical care programme supported by mHealth<br> | Other: Multidisciplinary follow-up programme supported by mHealth<br>* The follow-up programme integrates an online health platform (app and web) to monitor patients remotely, into the multidisciplinary team workflow, in order to improve heart transplant management. Patients will use the mobile application designed to help them to manage their health issues and facilitate communication with the transplant team. Data recorded manually by the patient using the mHealth application include pharmacotherapeutic information (medication adherence, barriers to adherence, side effects, interactions, etc.), clinical symptoms and other relevant clinical information (blood pressure, cardiac frequency, exercise, glucose level, diet, mood, etc.). mHealth will be used by the transplant team as a complementary way of deliver patient care. Analysis of the data collected by the multidisciplinary team may help to prioritise and provide personalized pharmacotherapeutic and medical interventions to patients and their families.<br>* Other names: Heart transplantation management by a multidisciplinary team and supported by mobile health (mHealth);|
| No Intervention: Routine healthcare by the transplant team<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence measured on validated scales and questionnaires | Change From Baseline in Medication Adherence on the Simplified Medication Adherence Questionnaire (SMAQ) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, multidisciplinary team, immunosuppressive medication, pharmaceutical care, adherence, heart transplant, recipients