This trial is active, not recruiting.

Condition heart transplant
Treatment multidisciplinary follow-up programme supported by mhealth
Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Start date October 2015
End date December 2016
Trial size 158 participants
Trial identifier NCT02554578, IIBSP-MHE-2014-55


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
multidisciplinary follow-up programme supported by mhealth Heart transplantation management by a multidisciplinary team and supported by mobile health (mHealth)
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.
(No Intervention)

Primary Outcomes

Medication adherence measured on validated scales and questionnaires
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effectiveness Improving Medication Adherence in Heart Transplant Management
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.