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Impact of mHealth in Heart Transplant Management (mHeart)

F

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

Status

Unknown

Conditions

Heart Transplant

Treatments

Other: Multidisciplinary follow-up programme supported by mHealth

Study type

Interventional

Funder types

Other

Identifiers

NCT02554578
IIBSP-MHE-2014-55

Details and patient eligibility

About

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).

Full 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.

Enrollment

158 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

158 participants in 2 patient groups

Pharmaceutical care programme supported by mHealth
Experimental group
Treatment:
Other: Multidisciplinary follow-up programme supported by mHealth
Routine healthcare by the transplant team
No Intervention group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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