Impact of mHealth in Heart Transplant Management (mHeart)

August 22, 2016 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Effectiveness Improving Medication Adherence in Heart Transplant Management

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

158

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmaceutical care programme supported by mHealth
Other: Multidisciplinary follow-up programme supported by 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.

Other Names:
  • Heart transplantation management by a multidisciplinary team and supported by mobile health (mHealth)
No Intervention: Routine healthcare by the transplant team

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIBSP-MHE-2014-55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe