Impact of mHealth in Heart Transplant Management
mHeart
Effectiveness Improving Medication Adherence in Heart Transplant Management
1 other identifier
interventional
158
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2015
CompletedFirst Posted
Study publicly available on registry
September 18, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedAugust 23, 2016
August 1, 2016
1.2 years
September 15, 2015
August 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication adherence measured on validated scales and questionnaires
Change From Baseline in Medication Adherence on the Simplified Medication Adherence Questionnaire (SMAQ)
6 months
Study Arms (2)
Pharmaceutical care programme supported by mHealth
EXPERIMENTALRoutine healthcare by the transplant team
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- Heart transplant patients ≥ 18 years of age
- Give informed consent.
- Be able to use a mobile device (smartphone).
- Sign a confidentiality agreement (interventional group).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
PMID: 36094829DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2015
First Posted
September 18, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2016
Last Updated
August 23, 2016
Record last verified: 2016-08