Heart FailureNCT06247371
Impact of a Novel Heart Failure Medication Decision Aid
A study testing Decision aid in people with Heart Failure, run by National University of Singapore at 1 site in Singapore.
Trial summary
A modified Zelen design randomised controlled trial over 6 months period is designed to investigate the influence of a heart failure medication decision aid prior to clinic session on shared decision making and its long term effect. Participants are randomised to either the decision aid arm or the usual care arm. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- 9 Apr 2024to 10 Feb 2025
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with heart failure with reduced ejection fraction (HFrEF)
- Singaporean nationality
Who cannot join
- Patient is currently on Medifund OR have Medical Claims Pro-ration System (MCPS)
- Pregnant
- Age 21 years and below
- Incapable of personally giving consent
- Unable to speak and read English or Chinese
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial of a Heart Failure Medication Decision Aid in Singapore
A modified Zelen design randomised controlled trial over 6 months period is designed to investigate the influence of a heart failure medication decision aid prior to clinic session on shared decision making and its long term effect. Participants are randomised to either the decision aid arm or the usual care arm.
Read the detailed description
A novel heart failure (HF) medication decision aid (DA) has been constructed, taking into account the needs of both patients and clinicians. Developed with a focus on brevity, this single-page DA is designed to offer patients a quick and concise overview of the information they desire about their medication ahead of their clinic session. It encompasses personalised cost information, considering the subsidies available in Singapore. The aim of the DA is to improve the communication between clinicians and HF patients. The conduct of this randomized controlled trial (RCT) is to study the effectiveness of the HF DA in the real-world setting.
Patients are randomized to either the DA arm or the usual care (UC) arm. In the DA group, patients will be provided with a DA featuring duration and frequency of use, benefits, side effect and cost information about angiotensin receptor neprilysin inhibitor and angiotensin-converting enzyme inhibitor medications. These patients will then be tasked to choose a preferred medication and reflect on which attribute holds the most significance for them. The preferred medication will be communicated to the clinicians during the clinic session. For the UC arm, clinicians will manage the encounter as per current usual routine.
- Conditions
- Heart Failure
- Being tested
- Decision aid
- Keywords
- Randomised controlled trial, Decision aid, Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidBehavioural
The Singapore developed HF DA is a A3 sized one-page poster designed to convey information about HF medications options (ACEI and ARNI only) and their pros and cons. The DA contains informative attributes of both medications that are presented side by side for comparison. These attributes include subsidized cost, frequency of use, duration of use, route of administration, low blood pressure side effect rate and benefits such as non-hospitalization rate and survival rate.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid | Experimental | Patients will be presented with a decision aid featuring personalized cost information, as well as other information about angiotensin receptor neprilysin inhibitor (ARNI) and angiotensin-converting enzyme inhibitor (ACEI) medications. These patients will then be tasked to choose a preferred medication and reflect on which attribute holds the most significance for them. The preferred medication will be communicated to the clinicians during the clinic session. Receives: Behavioral: Decision aid |
| Usual care | No intervention | Patients are managed as per usual clinical routine without the decision aid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Medication cost discussion
This outcome will be measured using an audio recording of the clinic session. Audio recording will be transcribed. The presence of cost discussion during the clinic session will coded based on Hunter et al. (2016) definition. Presence of cost discussion is coded as 1 and absence of cost discussion is coded as 0. Coding of cost discussion frequency will be done by 2 analysts who are blinded to the randomisation.
Measured: Day 1 (Clinic session)
Secondary outcomes (9)
Decisional conflict
Decisional conflict is defined as uncertainty when faced with choosing among competing options that can impact patient's personal values or well-being. The Decisional Conflict Scale (DCS) contains 16 items with 5 responses. The level of decisional conflict is reported from 0 to 100, with 0 indicating a high degree of certainty about the best choice and 100 indicating a significant degree of uncertainty about the best choice.
Measured: Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
Decision satisfaction
Patient's satisfaction with their decision will be measured with the Satisfaction with Decision Scale (SWD) developed by Holmes-Rovner. The SWD is a reliable tool consisting of 6 items. Respondents rate each item on a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree." A higher score indicates greater decisional satisfaction.
Measured: Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
Decision regret
The Decision Regret Scale (DRS) evaluates the degree of regret that an individual experiences after making a decision. DRS has demonstrated strong internal consistency and includes five items. A score of 0 suggests the absence of any regret, while a score of 100 indicates a high level of regret.
Measured: Day 180 (Follow-up appointment)
Prescribed medication agreement with preferred medication
Patient's prescribed medication record will be obtained from the electronic medical record. Their preferred medication choice will be documented after reading the decision aid. Presence of agreement is coded as 1 and presence of discrepancy is coded as 0.
Measured: Day 1 (Immediately after clinic session)
Health-related quality of life
Patients will assess their HRQoL with EuroQol scale (EQ-5D-5L). The EQ-5D-5L score is calculated using a standardized algorithm that considers five dimensions (mobility, self-care, usual activities, pain, and anxiety/depression). Each dimension has five response levels (no problems, slight problems, moderate problems, severe problems or extreme problems). The algorithm produces a level sum score that ranges from 5 to 25 with 25 being the worst health and 5 being perfect health.
Measured: Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
Financial toxicity
Patient's financial well-being will be assessed with COST-FACIT questionnaire. The questionnaire contains twelve items with a total score of 0 to 44. The higher the score, the better the financial well-being. The threshold for financial toxicity is defined as a score < 26.
Measured: Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
Readmission rate
Electronic medical record will be used to evaluate this outcome measures. The frequency of readmission into hospital within 6 months of recruitment will be tallied and compared between arms.
Measured: Day 180 (Follow-up appointment)
Heart Failure symptoms and Adverse drug reactions
Clinician's notes will be used to evaluate these two outcome measures. The frequency of various heart failure symptoms and drug reactions will be tallied within 6 months of recruitment and compared between arms.
Measured: Day 180 (Follow-up appointment)
Medication Adherence
Medication adherence will be captured by generating the Medication Possession Ratio using the pharmacy database. The higher the ratio, the better the medication adherence. The ratio between the two arms will be compared.
Measured: Day 180 (Follow-up appointment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start9 Apr 2024
- Primary completion25 Jul 2024
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study incorporates a prospective single centre, two arms parallel randomised controlled trial with 1:1 patient allocation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ng Teng Fong General Hospital
- Responsible party
- Principal investigator, Shen Qianyu, National University of Singapore
- Investigators
- Hwee Lin Wee, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247371
- Sponsor's protocol ID
- 2023/00772
- Other IDs
- 2023
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available for sharing upon request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of a Heart Failure Medication Decision Aid in Singapore
- ClinicalTrials.gov ID
- NCT06247371
- Acronym / sponsor ID
- 2023/00772
- Conditions
- Heart Failure
- Keywords
- Randomised controlled trial, Decision aid, Heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Ng Teng Fong General Hospital
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 7 Feb 2024 (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.
A modified Zelen design randomised controlled trial over 6 months period is designed to investigate the influence of a heart failure medication decision aid prior to clinic session on shared decision making and its long term effect. Participants are randomised to either the decision aid arm or the usual care arm.
Detailed description
A novel heart failure (HF) medication decision aid (DA) has been constructed, taking into account the needs of both patients and clinicians. Developed with a focus on brevity, this single-page DA is designed to offer patients a quick and concise overview of the information they desire about their medication ahead of their clinic session. It encompasses personalised cost information, considering the subsidies available in Singapore. The aim of the DA is to improve the communication between clinicians and HF patients. The conduct of this randomized controlled trial (RCT) is to study the effectiveness of the HF DA in the real-world setting.
Patients are randomized to either the DA arm or the usual care (UC) arm. In the DA group, patients will be provided with a DA featuring duration and frequency of use, benefits, side effect and cost information about angiotensin receptor neprilysin inhibitor and angiotensin-converting enzyme inhibitor medications. These patients will then be tasked to choose a preferred medication and reflect on which attribute holds the most significance for them. The preferred medication will be communicated to the clinicians during the clinic session. For the UC arm, clinicians will manage the encounter as per current usual routine.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study incorporates a prospective single centre, two arms parallel randomised controlled trial with 1:1 patient allocation.
| Arm | Type | Receives |
|---|---|---|
| Decision aid | Experimental | Behavioral: Decision aidPatients will be presented with a decision aid featuring personalized cost information, as well as other information about angiotensin receptor neprilysin inhibitor (ARNI) and angiotensin-converting enzyme inhibitor (ACEI) medications. These patients will then be tasked to choose a preferred medication and reflect on which attribute holds the most significance for them. The preferred medication will be communicated to the clinicians during the clinic session. |
| Usual care | No intervention | –Patients are managed as per usual clinical routine without the decision aid. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with heart failure with reduced ejection fraction (HFrEF)
- Singaporean nationality
Key exclusion criteria (5 listed)
- Patient is currently on Medifund OR have Medical Claims Pro-ration System (MCPS)
- Pregnant
- Age 21 years and below
- Incapable of personally giving consent
- Unable to speak and read English or Chinese
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 |
|---|---|---|
| Decision aidThe Singapore developed HF DA is a A3 sized one-page poster designed to convey information about HF medications options (ACEI and ARNI only) and their pros and cons. The DA contains informative attributes of both medications that are presented side by side for comparison. These attributes include subsidized cost, frequency of use, duration of use, route of administration, low blood pressure side effect rate and benefits such as non-hospitalization rate and survival rate. | Behavioural | Decision aid |
Primary outcome
Frequency of Medication cost discussion
Time frame: Day 1 (Clinic session)
This outcome will be measured using an audio recording of the clinic session. Audio recording will be transcribed. The presence of cost discussion during the clinic session will coded based on Hunter et al. (2016) definition. Presence of cost discussion is coded as 1 and absence of cost discussion is coded as 0. Coding of cost discussion frequency will be done by 2 analysts who are blinded to the randomisation.
9 secondary outcomes
Decisional conflict
Time frame: Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
Decision satisfaction
Time frame: Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
Decision regret
Time frame: Day 180 (Follow-up appointment)
Prescribed medication agreement with preferred medication
Time frame: Day 1 (Immediately after clinic session)
Health-related quality of life
Time frame: Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
Financial toxicity
Time frame: Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment)
Readmission rate
Time frame: Day 180 (Follow-up appointment)
Heart Failure symptoms and Adverse drug reactions
Time frame: Day 180 (Follow-up appointment)
Medication Adherence
Time frame: Day 180 (Follow-up appointment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: Yes. De-identified data will be made available for sharing upon request.
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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.
Hwee Lin Wee, PhD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Heart Failure, run by National University of Singapore at 1 site in Singapore.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of Medication cost discussion (time frame: Day 1 (Clinic session)). 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 11 Feb 2025.