Heart TransplantmHeartNCT02554578
Impact of mHealth in Heart Transplant Management
A study testing Multidisciplinary follow-up programme supported by mHealth in people with Heart Transplant, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant
- What is being tested?
- Multidisciplinary follow-up programme supported by mHealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart transplant patients ≥ 18 years of age
- Give informed consent.
- Be able to use a mobile device (smartphone).
- Sign a confidentiality agreement (interventional group).
Who cannot join
- 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
About this study
Official title: 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).
Read the 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.
- Conditions
- Heart Transplant
- Being tested
- Multidisciplinary follow-up programme supported by mHealth
- Keywords
- mHealth, multidisciplinary team, immunosuppressive medication, pharmaceutical care, adherence, heart transplant, recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary follow-up programme supported by mHealthOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmaceutical care programme supported by mHealth | Experimental | Not described Receives: Other: Multidisciplinary follow-up programme supported by mHealth |
| Routine healthcare by the transplant team | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence measured on validated scales and questionnaires
Change From Baseline in Medication Adherence on the Simplified Medication Adherence Questionnaire (SMAQ)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart TransplantStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554578
- Sponsor's protocol ID
- IIBSP-MHE-2014-55
- Acronym
- mHeart
- Status last verified
- Aug 2016
- First submitted
- 15 Sep 2015
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36094829
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Improving Medication Adherence in Heart Transplant Management
- ClinicalTrials.gov ID
- NCT02554578
- Acronym / sponsor ID
- mHeart / IIBSP-MHE-2014-55
- Conditions
- Heart Transplant
- Keywords
- mHealth, multidisciplinary team, immunosuppressive medication, pharmaceutical care, adherence, heart transplant, recipients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmaceutical care programme supported by mHealth | Experimental | Other: Multidisciplinary follow-up programme supported by mHealth |
| Routine healthcare by the transplant team | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Heart transplant patients ≥ 18 years of age
- Give informed consent.
- Be able to use a mobile device (smartphone).
- Sign a confidentiality agreement (interventional group).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary follow-up programme supported by mHealthAlso: 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. | Other | Pharmaceutical care programme supported by mHealth |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Derived from this study: PubMed 36094829Mellon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary follow-up programme supported by mHealth in people with Heart Transplant, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence measured on validated scales and questionnaires (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02554578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.