Heart Failure With Reduced Ejection Fraction (HFrEF)NCT06900803
Evaluating Dashboard-Integrated Pharmacist-Led Education on Improving Sacubitril/Valsartan Adherence in Heart Failure (PharmD ASSIST HFrEF)
A study testing interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard) in people with Heart Failure With Reduced Ejection Fraction (HFrEF) and Sacubitril/Valsartan, run by National Taiwan University Hospital.
Trial summary
The goal of this pragmatic clinical trial is to evaluate whether pharmacist-led education, integrated with interactive visualization dashboards, can enhance medication adherence in patients with heart failure who are prescribed sacubitril/valsartan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HFrEF), Sacubitril/Valsartan, Medication Adherence
- What is being tested?
- interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 7 Apr 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults aged 20 or older
- a diagnosis of HFrEF, which is defined by a left ventricular ejection fraction of 40% or less
- currently receiving sacubitril/valsartan at the time of recruitment
- receiving care at the cardiology department or cardiology ward at National Taiwan University Hospital
- referral from the clinicians at National Taiwan University Hospital
Who cannot join
- unable or unwilling to provide informed consent, adhere to study protocols, or complete required questionnaires in person during three scheduled visits (i.e., 3, 6, 12 months after the baseline measurement)
- having received care at the pharmacist-led HF clinic at National Taiwan University Hospital
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pharmacist-Led Education Through Interactive Visualization Dashboards for Adherence Support and Sustained Involvement in Sacubitril/Valsartan Therapy for Patients With Heart Failure With Reduced Ejection Fraction (PharmD ASSIST HFrEF): Study Protocol for Implementation in a Parallel-Group, Pragmatic Randomized Controlled Trial
The goal of this pragmatic clinical trial is to evaluate whether pharmacist-led education, integrated with interactive visualization dashboards, can enhance medication adherence in patients with heart failure who are prescribed sacubitril/valsartan. The main question it aims to answer is: Can pharmacist-led interactive visualization dashboards improve adherence to sacubitril/valsartan compared to usual care without the dashboard intervention?
Researchers will compare patients receiving pharmacist-led education with interactive dashboards to those receiving standard education, assessing differences in medication adherence and clinical outcomes, among others.
Read more
Participants will:
- Complete baseline and follow-up questionnaires on medication adherence and satisfaction with pharmacist-provided services, and others.
- Engage in education sessions led by pharmacists, with or without dashboard integration.
The study outcomes will include medication adherence, and secondary outcomes such as patient satisfaction with pharmacist-provided services, optimized guideline-directed medical therapy score, time to high medication adherence, the calculated proportion of days covered, New York Heart Association functional classification, and the net promoter score used for evaluating recommendation and satisfaction with the dashboard intervention.
- Conditions
- Heart Failure With Reduced Ejection Fraction (HFrEF), Sacubitril/Valsartan, Medication Adherence
- Being tested
- interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard)
- Keywords
- heart failure with reduced ejection fraction, medication adherence, dashboard, health information technology, patient education, pharmacist, pragmatic trial, randomized controlled trial, sacubitril/valsartan, implementation
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard)Device
The dashboard serves as an interactive communication tool during education sessions, promoting real-time dialogue between patients and pharmacists. By collaboratively entering patient-specific data, patients gain insight into personalized visual representations of actionable risk factors. Initially, data specific to the patient are inputted to generate a baseline assessment, presenting hazard ratios that indicate the current condition and pinpoint areas needing improvement. To simulate potential changes, an alternative dataset is deliberately entered, portraying either improvement or deterioration in the patient's status, thereby acting as a motivational tool. Throughout the education session, the dashboard continuously updates hazard ratios, enabling direct comparisons of patient outcomes under varying conditions or treatment scenarios. This dynamic process clearly demonstrates individualized risk-benefit trade-offs in diverse treatment contexts.
| Study group | Role | What they receive |
|---|---|---|
| Low Adherence Cluster - Intervention Group | Experimental | Dashboard interventions integrated into pharmacist-led education in the low adherence cluster Receives: Device: interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard) |
| Low Adherence Cluster - Control Group | No intervention | Pragmatic pharmacist-led education, without dashboard interventions, in the low adherence cluster |
| High Adherence Cluster - Intervention Group | Experimental | Dashboard interventions integrated into pharmacist-led education in the high adherence cluster Receives: Device: interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard) |
| High Adherence Cluster - Control Group | No intervention | Pragmatic pharmacist-led education, without dashboard interventions, in the high adherence cluster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence to sacubitril/valsartan
Medication adherence will be assessed using the Morisky 8-item Medication Adherence Scale (MMAS-8) for sacubitril/valsartan, with scores ranging from 0 to 8, where higher scores indicate better medication adherence.
Measured: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
Secondary outcomes (7)
Patient satisfaction with pharmacist-provided services
Patient satisfaction will be assessed using the adapted Traditional Chinese version of the modified Patient Satisfaction with Pharmacist Services Questionnaire 2.0 (C-mPSPSQ 2.0). C-mPSPSQ 2.0 is a 6-item scale, with scores ranging from 4 to 24, where higher scores indicate better patient satisfaction with pharmacist-provided services.
Measured: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
Optimized guideline-directed medical therapy (GDMT) score
The score, adapted from the ΔGDMT score from Man et al. (2024) and the Optimization Potential Score from Verma et al. (2023), is calculated by dividing the received dose by the target dose based on each class of GDMT according to the current HF guidelines, ranging from 0 to 1 per medication of GDMT. The maximum total score per patient is 5, with four pillars of GDMT and extra one point for a switch from ACEI/angiotensin receptor blockers to sacubitril/valsartan due to the complexity of reimbursement in Taiwan. If valid reasons for not prescribing GDMT are documented in the electronic health records, a score of 1 will still be assigned for each instance.
Measured: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
Medication adherence to guideline-directed medical therapy (GDMT)
Medication adherence will be assessed using the Morisky 8-item Medication Adherence Scale (MMAS-8) for GDMT, with scores ranging from 0 to 8, where higher scores indicate better medication adherence.
Measured: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
Time to high medication adherence
The time to achieving high medication adherence (defined as a score of 8 on the Morisky 8-item Medication Adherence Scale [MMAS-8]) will be analyzed separately for patients who attain high adherence to sacubitril/valsartan and guideline-directed medical therapy (GDMT), with scores ranging from 0 to 8, where higher scores indicate better medication adherence.
Measured: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
Proportion of days covered (PDC)
The PDC will also be calculated to triangulate and validate the results of the Morisky 8-item Medication Adherence Scale (MMAS-8). The data of the PDC will be accessed through the National Health Insurance MediCloud System in Taiwan. The PDC for each guideline-directed medical therapy (GDMT) is calculated by the total days covered in the period divided by the total prescription days in the period, with the common threshold of 80% indicating acceptable medication adherence.
Measured: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
New York Heart Association (NYHA) functional classification
The NYHA functional classification, which categorizes heart failure severity into four classes based on symptoms and limitations to physical activity, will be assessed by pharmacists.
Measured: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
Net Promoter Score (NPS)
The level of participant endorsement for the intervention (i.e., the ESAIC dashboard) will help identify areas for further enhancement and support its integration into routine clinical practice. The NPS ranges from 1 to 10, with increments of 1, and is classified into three distinct categories: promoters (scoring 9 or 10), passives (scoring 7 or 8), and detractors (scoring 6 or below). In this trial, both pharmacists and patients will provide NPS ratings.
Measured: From enrollment to the end of treatment at 12 months (two key time points: baseline (T0) and 3 months (T1) post-randomization).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start7 Apr 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900803
- Sponsor's protocol ID
- 202501197RINC
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We believe that safeguarding patient confidentiality is of utmost importance, and the current study protocol does not include provisions for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-Led Education Through Interactive Visualization Dashboards for Adherence Support and Sustained Involvement in Sacubitril/Valsartan Therapy for Patients With Heart Failure With Reduced Ejection Fraction (PharmD ASSIST HFrEF): Study Protocol for Implementation in a Parallel-Group, Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06900803
- Acronym / sponsor ID
- 202501197RINC
- Conditions
- Heart Failure With Reduced Ejection Fraction (HFrEF), Sacubitril/Valsartan, Medication Adherence
- Keywords
- heart failure with reduced ejection fraction, medication adherence, dashboard, health information technology, patient education, pharmacist, pragmatic trial, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 7 Apr 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 28 Mar 2025 (actual)
- 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 goal of this pragmatic clinical trial is to evaluate whether pharmacist-led education, integrated with interactive visualization dashboards, can enhance medication adherence in patients with heart failure who are prescribed sacubitril/valsartan. The main question it aims to answer is: Can pharmacist-led interactive visualization dashboards improve adherence to sacubitril/valsartan compared to usual care without the dashboard intervention?
Researchers will compare patients receiving pharmacist-led education with interactive dashboards to those receiving standard education, assessing differences in medication adherence and clinical outcomes, among others.
Participants will:
- Complete baseline and follow-up questionnaires on medication adherence and satisfaction with pharmacist-provided services, and others.
- Engage in education sessions led by pharmacists, with or without dashboard integration.
The study outcomes will include medication adherence, and secondary outcomes such as patient satisfaction with pharmacist-provided services, optimized guideline-directed medical therapy score, time to high medication adherence, the calculated proportion of days covered, New York Heart Association functional classification, and the net promoter score used for evaluating recommendation and satisfaction with the dashboard intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Adherence Cluster - Intervention Group | Experimental | Device: interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard)Dashboard interventions integrated into pharmacist-led education in the low adherence cluster |
| Low Adherence Cluster - Control Group | No intervention | –Pragmatic pharmacist-led education, without dashboard interventions, in the low adherence cluster |
| High Adherence Cluster - Intervention Group | Experimental | Device: interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard)Dashboard interventions integrated into pharmacist-led education in the high adherence cluster |
| High Adherence Cluster - Control Group | No intervention | –Pragmatic pharmacist-led education, without dashboard interventions, in the high adherence cluster |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adults aged 20 or older
- a diagnosis of HFrEF, which is defined by a left ventricular ejection fraction of 40% or less
- currently receiving sacubitril/valsartan at the time of recruitment
- receiving care at the cardiology department or cardiology ward at National Taiwan University Hospital
- referral from the clinicians at National Taiwan University Hospital
Key exclusion criteria (2 listed)
- unable or unwilling to provide informed consent, adhere to study protocols, or complete required questionnaires in person during three scheduled visits (i.e., 3, 6, 12 months after the baseline measurement)
- having received care at the pharmacist-led HF clinic at National Taiwan University Hospital
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 |
|---|---|---|
| interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard)The dashboard serves as an interactive communication tool during education sessions, promoting real-time dialogue between patients and pharmacists. By collaboratively entering patient-specific data, patients gain insight into personalized visual representations of actionable risk factors. Initially, data specific to the patient are inputted to generate a baseline assessment, presenting hazard ratios that indicate the current condition and pinpoint areas needing improvement. To simulate potential changes, an alternative dataset is deliberately entered, portraying either improvement or deterioration in the patient's status, thereby acting as a motivational tool. Throughout the education session, the dashboard continuously updates hazard ratios, enabling direct comparisons of patient outcomes under varying conditions or treatment scenarios. This dynamic process clearly demonstrates individualized risk-benefit trade-offs in diverse treatment contexts. | Device | High Adherence Cluster - Intervention Group, Low Adherence Cluster - Intervention Group |
Primary outcome
Medication adherence to sacubitril/valsartan
Time frame: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
Medication adherence will be assessed using the Morisky 8-item Medication Adherence Scale (MMAS-8) for sacubitril/valsartan, with scores ranging from 0 to 8, where higher scores indicate better medication adherence.
7 secondary outcomes
Patient satisfaction with pharmacist-provided services
Time frame: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
Optimized guideline-directed medical therapy (GDMT) score
Time frame: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
Medication adherence to guideline-directed medical therapy (GDMT)
Time frame: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
Time to high medication adherence
Time frame: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
Proportion of days covered (PDC)
Time frame: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
New York Heart Association (NYHA) functional classification
Time frame: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
Net Promoter Score (NPS)
Time frame: From enrollment to the end of treatment at 12 months (two key time points: baseline (T0) and 3 months (T1) post-randomization).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No. We believe that safeguarding patient confidentiality is of utmost importance, and the current study protocol does not include provisions for public data sharing.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard) in people with Heart Failure With Reduced Ejection Fraction (HFrEF) and Sacubitril/Valsartan, run by National Taiwan University Hospital.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 2 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wan-Tseng Hsu, PhD (+886 2 - 3366 - 8195, wantsenghsu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence to sacubitril/valsartan (time frame: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2025.