Heart Failure With Reduced Ejection Fraction, HIV Infections
Conditions
Keywords
Medication adherence, Polypill
Brief summary
A novel four-drug regimen for heart failure with reduced ejection fraction (HFrEF) extends patients' life expectancy by an average of 6 years compared to traditional therapies, in addition to improving quality of life. Unfortunately, uptake of this complex multi-drug regimen has been low, especially among underserved communities with barriers to medication adherence. Although combination tablets have transformed access to care for conditions such as HIV and tuberculosis, no combination pill is available for HFrEF. In the proposed study, the investigators will utilize inexpensive over-encapsulation techniques to develop a novel combination pill (polypill) for patients with HFrEF. In Aim 1, the investigators will conduct stakeholder interviews with patients, providers, and pharmacists to inform the design of a HFrEF polypill. In Aim 2, the investigators will conduct a pilot, single-center, crossover randomized clinical trial to investigate whether, compared to usual care, a HFrEF polypill increases medication adherence among 20-40 adults with HFrEF. Given the high daily pill burden among patients with HIV and HFrEF, the investigators aim to recruit a subgroup of patients with HIV (\ 10-20 participants) in addition to a subgroup of patients without HIV (\ 10-20 participants).
Detailed description
Hypothesis: Compared with usual care, a HFrEF polypill implementation strategy will increase adherence to GDMT 4 weeks and reduce total daily pill burden among patients with HFrEF. Rationale:HFrEF among PWH is associated with a high pill burden, which adversely impacts adherence. Over-encapsulation is an inexpensive and replicable method to co-package several tablets into a single capsule at the level of the pharmacy. However, the role of over-encapsulation to reduce pill burden among adults with HIV and HFrEF is unknown. Design: Pilot phase II open-label randomized trial with a 2x2 crossover design (AB/BA) Intervention: The intervention will be pharmacy-level over-encapsulation of once-daily heart failure medications (beta-blocker, SGLT2 inhibitor, spironolactone, and ACE/ARB/ARNI) into a single capsule. For some patients, other once-daily cardiovascular medications, such as a diuretic, may be included if capsule size allows (otherwise, these medications will continued to be filled separate to the polypill, as individual tablets). If the patient uses a twice-daily ARNI medication, the morning dose may be included in the polypill and the PM dose will continue to be dispensed separately. The investigators will partner with Daniel's Pharmacy, a local community pharmacy with proficiency in over-encapsulation and over 20 years' experience working with ZSFG to deliver adherence interventions. Polypill Description: For patients in the polypill arm, heart failure medications will be filled as usual, but rather than dispensing each medication separately, the pharmacy technician will hand-pack all once-daily heart failure medications into a small plastic capsule. The doses will be individualized to the patient based on their physician's prescription. Thus, the polypill will be a late-stage implementation intervention to reduce pill burden, without restricting dose possibilities or interfering with medication titration. Visit Schedule and Randomization: Patients will first attend an intake visit (week T-1), where eligibility will be reviewed, informed consent will be obtained, baseline patient questionnaires will be collected, and additional GDMT agents may be prescribed by the study clinician if clinically indicated and there are no contraindications. At the first trial visit (week 0), baseline labs will be collected and additional GDMT agents may prescribed if clinically indicated, with the goal of all participants being prescribed guideline-directed quad therapy for HFrEF prior to randomization if there are no contraindications. During the first trial visit (week 0), half of participants will be randomized to the AB group (polypill for 4 weeks, then individual tablets for 4 weeks). The other half of participants will be randomized to the BA group (individual tablets for 4 weeks, then polypill for 4 weeks). After randomization, participants assigned to receive the polypill up-front will be delivered 30-day supplies of the polypill via their preferred delivery method (mail, pick up at a ZSFG clinic, or pick up at Daniel's Pharmacy). Participants assigned to usual care will be mailed or pick up their existing heart failure medications as individual pills. The screening visit and first trial visit may be timed by study clinicians based on when the participant's heart failure medications will be ready for a refill according to insurance. At trial follow-up visits at 4 and 8 weeks, participants will be assessed for outcomes and adverse events and will undergo lab monitoring as clinically indicated. Patients will be asked to bring in their pill bottles and/or MediSets or bubble packs. Medication doses may be titrated at these visits if clinically indicated. Participants in the AB and BA arms will have the same follow-up schedule, and can opt to receive refills of their medications by mail, at the pharmacy, or in clinic. Any new starts of guideline-directed heart failure medications that are included in the polypill will be continued as individual pills when the polypill group crosses over to the individual tablet condition, and/or when the trial concludes. All participants will be referred to cardiology clinic, if not already established there, for ongoing management of their heart failure therapies after the trial.
Interventions
DRUGHeart failure polypill
Copackaging of heart failure medications (beta blocker, SGLT2i, MRA, and ACE/ARB/ARNI) in an overencapsulated polypill. Individual tablets will be hand-packed into a single capsule at the level of the pharmacy. Specific medications and doses will be individualized to the participant.
DRUGControl Rx
GDMT delivered as individual tablets
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults age 18+ with heart failure (current or prior NYHA stage II-IV) * Ejection fraction \<50% on the most recent echocardiogram or MRI * Last eGFR \> 30 * Able to conveniently obtain medications through one of 3 available mechanisms (mail, pick up at a ZSFG clinic, or pick up at Daniel's pharmacy) * Working phone number for telephone visits * In addition to the inclusion criteria above, the investigators will preferentially recruit the following patient groups: people with HIV for a recruitment subgroup; patients who are less connected to cardiology care; people who are on \<4 pillars of GDMT, and have difficulty with medication adherence (as evidenced by detectable HIV viral load or refill gaps in Epic); and people who do not use bubble packs and do not have daily medication support staff for med administration.
Exclusion criteria
* Patients who are not fluent in English (due to constraints of the small pilot trial) * Patients who are incarcerated * Patients who cannot provide informed consent * Patients with a ventricular assist device (VAD) or patients with an MI, unstable angina, stroke, or TIA within 12 weeks prior to enrollment * Women who are pregnant, breastfeeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods). * Concomitant medical condition which in the opinion of the study team could interfere with the safe conduct of the study including outcome assessment. * Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible. * Participant's responsible physician believes it is not appropriate for participant to take part in the study. * Unable to complete study procedures and/or plan to move out of the study area in the next 2 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measured Adherence to GDMT by Pill Count | The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use. | The primary outcome will be overall adherence to GDMT, as determined by pill count. We will first calculate the % adherence ratio for each prescribed class of GDMT (# pills missing / # pills supposed to be missing). The adherence ratio for each prescribed class of GDMT will then be averaged to derive the overall adherence ratio to GDMT. Pill count may be performed in-office or over videoconferencing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implementation Outcome: Time Required to Manufacture the HFrEF Polypill at Our Community Pharmacy Partner | Assessed at week 0 or week 4 | Time required to prepare a 30-day supply of HFrEF polypill |
| Implementation Outcome: Cost of HFrEF Polypill Manufacturing at Our Community Pharmacy Partner | Assessed at week 0 or week 4 | Cost of manufacturing a 30-day supply of HFrEF polypill |
| Morisky Medication Adherence-8 (MMAS-8) Questionnaire | The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use. | The MMAS-8 scale consists of 8 items. Each of the first 7 items has 2 possible responses (yes/no), while the 8th item is answered with a 5-point Likert scale. The possible total medication adherence score ranges between 0 and 8, and the higher the score, the better the adherence level. A total score \< 6 is considered low adherence, while a total score of ≥ 6 but \< 8 indicates moderate adherence, and a score of 8 indicates high adherence. |
| Treatment Satisfaction Using the Treatment Satisfaction Questionnaire for Medication (TSQM 9) | The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use. | TSQM scores range from 0 to 100, with higher scores indicating greater treatment satisfaction. |
| Heart Failure Admission Rate | The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use. | As a pilot trial, our study will not be powered for clinical outcomes, but key exploratory outcomes will include HFrEF admissions. |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) 12 | The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use. | Exploratory clinical outcomes will include change in health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire. KCCQ scores range from 0 to 100, with higher scores indicating higher quality of life. |
| Adherence Ratio to Individual Components of GDMT by Pill Count | The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use. | The investigators will calculate the adherence ratio for each individual component of GDMT (beta blocker, MRA, SGLT2i, and ACE/ARB/ARNI). This will be calculated as the (# pills missing) / (# pills supposed to be missing based on time elapsed between visits). This will allow us to investigate whether there is differential adherence to some categories of GDMT (for example, lower adherence to beta-blockers). |
| Blood Pressure (mmHg) | The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use. | Systolic Blood pressure at baseline and study follow-up |
| Heart Rate | The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use. | Heart rate (beats per minute) |
| Number of Participants Completing a Qualitative Exit Interview | After study completion (between 8 and 12 weeks) | Participation in a semi-structured exit interview using a RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) |
| Number of Days Off of GDMT | Assessed at weeks 4 and 8 | Number of days off GDMT due to a clinical event (e.g. hospitalization) or due to logistical / pharmacy issues |
| Weight | The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use. | Weight at baseline and study follow-up |
| NT-ProBNP | The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use. | Lab test |
| Adverse Events | 0, 2, 4, 6, and 8 weeks | The investigators will document adverse events throughout the study period, for example, hyperkalemia, dizziness, or other medication-related side effects. The investigators will ask participants about adverse events at in-person visits (0, 4, and 8 weeks) and at telephone calls at approximately 2 and 6 weeks. |
| Total Daily Pill Burden of the Patient | The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use. | This will be calculated based on the patient's active medication list. |
| Number of GDMT Pillars Prescribed | The outcome will be measured 1) at the start of the polypill intervention, and 2) at the start of the individual tablet intervention. | The number of GDMT pillars prescribed to the patient (BB, MRA, SGLT2i, and either ACEi, ARB, or ARNI) will be calculated at baseline and week 4. |
| HFrEF Polypill Patient Satisfaction Exit Survey | After study completion | A Likert scale-style exit survey will be administered asking participants to compare their experience with the HFrEF polypill vs. individual tablets. 4 questions will comprise an Acceptability of Intervention Measure (AIM): 1) the polypill met my approval; 2) the polypill was appealing to me; 3) I liked the polypill; and 4) I welcomed the polypill as a treatment option for my heart failure. Each question includes a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree). Participants' responses to the 4 AIM questions will be averaged to comprise an AIM summary score. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment | Completion of recruitment within 1 year of initiating recruitment | Number of months taken to recruit 30-40 people to consent to participate in the study |
| Feasibility of Adherence to Study Protocols | Assessed following study completion (approximately 1 year) | Successful completion of study related procedures for at least 20 participants (screening, randomization, drug allocation, follow-up procedures, retention, and transition to ongoing care) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GDMT Delivered in a Heart Failure Polypill First (Individual Tablets Second) The polypill intervention will be pharmacy-level over-encapsulation of heart failure medications (beta-blocker, SGLT2 inhibitor, mineralocorticoid receptor antagonist, and ACE/ARB/ARNI) into a single capsule. For patients on twice-daily sacubitril/valsartan, one dose will be included in the polypill and the second dose will be dispensed separately. The investigators will partner with a local community pharmacy with proficiency in over-encapsulation. For patients in the polypill arm, heart failure medications will be filled as usual, but rather than dispensing each medication separately, the pharmacy technician will hand-pack all once-daily heart failure medications into a small vegan capsule. This group is assigned to polypill first and individual tablets second. | 17 |
| GDMT Delivered as Individual Tablets First (Polypill Second) As described above, participants who are not already prescribed a beta blocker, SGLT2i, ACE/ARB/ARNI, and MRA will be initiated on these medications prior to randomization if no contraindications exist. Participants randomized to usual care will receive their heart failure medications as individual pills. They will have the option to receive medications by mail, clinic pick-up, or pharmacy pick-up. After 1 month, participants assigned to individual tablets first will be switched to the polypill intervention. | 18 |
| Total | 35 |
Baseline characteristics
| Characteristic | GDMT Delivered in a Heart Failure Polypill First (Individual Tablets Second) | GDMT Delivered as Individual Tablets First (Polypill Second) | Total |
|---|---|---|---|
| Age, Continuous | 55 years | 50.5 years | 54 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 14 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 7 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 3 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 9 Participants |
| Sex: Female, Male Male | 15 Participants | 11 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 5 / 31 | 6 / 30 |
| serious Total, serious adverse events | 1 / 31 | 1 / 30 |
Outcome results
Primary
Measured Adherence to GDMT by Pill Count
The primary outcome will be overall adherence to GDMT, as determined by pill count. We will first calculate the % adherence ratio for each prescribed class of GDMT (# pills missing / # pills supposed to be missing). The adherence ratio for each prescribed class of GDMT will then be averaged to derive the overall adherence ratio to GDMT. Pill count may be performed in-office or over videoconferencing.
Time frame: The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.
Population: As part of the crossover analysis, the individual tablet periods were combined from both assignment groups (individual tablets first and polypill first), and the polypill periods were combined.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Individual Tablets | Measured Adherence to GDMT by Pill Count | 74.6 adherence ratio expressed in % |
| Polypill | Measured Adherence to GDMT by Pill Count | 83.3 adherence ratio expressed in % |
Secondary
Adherence Ratio to Individual Components of GDMT by Pill Count
The investigators will calculate the adherence ratio for each individual component of GDMT (beta blocker, MRA, SGLT2i, and ACE/ARB/ARNI). This will be calculated as the (# pills missing) / (# pills supposed to be missing based on time elapsed between visits). This will allow us to investigate whether there is differential adherence to some categories of GDMT (for example, lower adherence to beta-blockers).
Time frame: The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.
Population: Included participants who had this measure for both study periods (polypill and individual tablets); for beta blockers this is 23, ACE/ARB/ARNI 23, MRA 26, and SGLT2i 22.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Individual Tablets | Adherence Ratio to Individual Components of GDMT by Pill Count | Beta Blockers | 73.8 adherence ratio expressed in % |
| Individual Tablets | Adherence Ratio to Individual Components of GDMT by Pill Count | ACE/ARB/ARNI | 71.1 adherence ratio expressed in % |
| Individual Tablets | Adherence Ratio to Individual Components of GDMT by Pill Count | MRA | 74.4 adherence ratio expressed in % |
| Individual Tablets | Adherence Ratio to Individual Components of GDMT by Pill Count | SGLT2i | 73.4 adherence ratio expressed in % |
| Polypill | Adherence Ratio to Individual Components of GDMT by Pill Count | SGLT2i | 81.6 adherence ratio expressed in % |
| Polypill | Adherence Ratio to Individual Components of GDMT by Pill Count | Beta Blockers | 83.6 adherence ratio expressed in % |
| Polypill | Adherence Ratio to Individual Components of GDMT by Pill Count | MRA | 83.7 adherence ratio expressed in % |
| Polypill | Adherence Ratio to Individual Components of GDMT by Pill Count | ACE/ARB/ARNI | 80.4 adherence ratio expressed in % |
Secondary
Adverse Events
The investigators will document adverse events throughout the study period, for example, hyperkalemia, dizziness, or other medication-related side effects. The investigators will ask participants about adverse events at in-person visits (0, 4, and 8 weeks) and at telephone calls at approximately 2 and 6 weeks.
Time frame: 0, 2, 4, 6, and 8 weeks
Population: Safety endpoints include participants who started the intervention but did not complete it due to study dropout or loss to follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Individual Tablets | Adverse Events | Serious Adverse Events | 1 Participants |
| Individual Tablets | Adverse Events | Any Adverse Event | 6 Participants |
| Polypill | Adverse Events | Serious Adverse Events | 1 Participants |
| Polypill | Adverse Events | Any Adverse Event | 7 Participants |
Secondary
Blood Pressure (mmHg)
Systolic Blood pressure at baseline and study follow-up
Time frame: The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.
Population: Included participants who had this measure for both study periods (polypill and individual tablets).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Individual Tablets | Blood Pressure (mmHg) | 126 mm Hg |
| Polypill | Blood Pressure (mmHg) | 124 mm Hg |
Secondary
Heart Failure Admission Rate
As a pilot trial, our study will not be powered for clinical outcomes, but key exploratory outcomes will include HFrEF admissions.
Time frame: The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.
Population: For safety endpoints the number of participants included any participant who started that intervention period, so it is higher than then number analyzed who completed the efficacy outcome measures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individual Tablets | Heart Failure Admission Rate | 0 Participants |
| Polypill | Heart Failure Admission Rate | 1 Participants |
Secondary
Heart Rate
Heart rate (beats per minute)
Time frame: The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.
Population: Included participants who had this measure for both study periods (polypill and individual tablets).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Individual Tablets | Heart Rate | 77 beats per minute |
| Polypill | Heart Rate | 77 beats per minute |
Secondary
HFrEF Polypill Patient Satisfaction Exit Survey
A Likert scale-style exit survey will be administered asking participants to compare their experience with the HFrEF polypill vs. individual tablets. 4 questions will comprise an Acceptability of Intervention Measure (AIM): 1) the polypill met my approval; 2) the polypill was appealing to me; 3) I liked the polypill; and 4) I welcomed the polypill as a treatment option for my heart failure. Each question includes a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree). Participants' responses to the 4 AIM questions will be averaged to comprise an AIM summary score.
Time frame: After study completion
Population: All participants who completed both intervention periods.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Individual Tablets | HFrEF Polypill Patient Satisfaction Exit Survey | 4.75 Score on a 5-point scale |
Secondary
Implementation Outcome: Cost of HFrEF Polypill Manufacturing at Our Community Pharmacy Partner
Cost of manufacturing a 30-day supply of HFrEF polypill
Time frame: Assessed at week 0 or week 4
Population: All participants who had polypills manufactured were included. The cost of manufacturing was the same for each patient, and was determined by the pharmacy partner (i.e. time and labor cost of preparing 1 month of polypill supply for 1 patient).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Tablets | Implementation Outcome: Cost of HFrEF Polypill Manufacturing at Our Community Pharmacy Partner | 60 Dollars | Standard Deviation 0 |
Secondary
Implementation Outcome: Time Required to Manufacture the HFrEF Polypill at Our Community Pharmacy Partner
Time required to prepare a 30-day supply of HFrEF polypill
Time frame: Assessed at week 0 or week 4
Population: The pharmacy measured the time it took them to prepare the polypills for a subset of participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Tablets | Implementation Outcome: Time Required to Manufacture the HFrEF Polypill at Our Community Pharmacy Partner | 27 minutes | Standard Deviation 4 |
Secondary
Kansas City Cardiomyopathy Questionnaire (KCCQ) 12
Exploratory clinical outcomes will include change in health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire. KCCQ scores range from 0 to 100, with higher scores indicating higher quality of life.
Time frame: The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.
Population: Included participants who had this measure for both study periods (polypill and individual tablets).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Individual Tablets | Kansas City Cardiomyopathy Questionnaire (KCCQ) 12 | 67.9 Overall Summary Score |
| Polypill | Kansas City Cardiomyopathy Questionnaire (KCCQ) 12 | 70.6 Overall Summary Score |
Secondary
Morisky Medication Adherence-8 (MMAS-8) Questionnaire
The MMAS-8 scale consists of 8 items. Each of the first 7 items has 2 possible responses (yes/no), while the 8th item is answered with a 5-point Likert scale. The possible total medication adherence score ranges between 0 and 8, and the higher the score, the better the adherence level. A total score \< 6 is considered low adherence, while a total score of ≥ 6 but \< 8 indicates moderate adherence, and a score of 8 indicates high adherence.
Time frame: The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.
Population: Included participants who had this measure for both study periods (polypill and individual tablets).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Individual Tablets | Morisky Medication Adherence-8 (MMAS-8) Questionnaire | 4.1 Total Score |
| Polypill | Morisky Medication Adherence-8 (MMAS-8) Questionnaire | 4.6 Total Score |
Secondary
NT-ProBNP
Lab test
Time frame: The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.
Population: Included participants who had this measure for both study periods (polypill and individual tablets).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Individual Tablets | NT-ProBNP | 1040.5 pg/ml |
| Polypill | NT-ProBNP | 1086.5 pg/ml |
Secondary
Number of Days Off of GDMT
Number of days off GDMT due to a clinical event (e.g. hospitalization) or due to logistical / pharmacy issues
Time frame: Assessed at weeks 4 and 8
Population: The analysis population includes all participants who started the intervention period and were not lost to follow up during that intervention period.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Individual Tablets | Number of Days Off of GDMT | 8+days | 1 Participants |
| Individual Tablets | Number of Days Off of GDMT | 4-7 days | 0 Participants |
| Individual Tablets | Number of Days Off of GDMT | 0 days | 27 Participants |
| Individual Tablets | Number of Days Off of GDMT | 1-3 days | 1 Participants |
| Polypill | Number of Days Off of GDMT | 0 days | 23 Participants |
| Polypill | Number of Days Off of GDMT | 8+days | 0 Participants |
| Polypill | Number of Days Off of GDMT | 1-3 days | 3 Participants |
| Polypill | Number of Days Off of GDMT | 4-7 days | 1 Participants |
Secondary
Number of GDMT Pillars Prescribed
The number of GDMT pillars prescribed to the patient (BB, MRA, SGLT2i, and either ACEi, ARB, or ARNI) will be calculated at baseline and week 4.
Time frame: The outcome will be measured 1) at the start of the polypill intervention, and 2) at the start of the individual tablet intervention.
Population: This is measured at the start of each intervention period (because medication changes were only made for safety during each intervention period) so it includes all those who started each intervention period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Individual Tablets | Number of GDMT Pillars Prescribed | Beta Blocker | 30 Participants |
| Individual Tablets | Number of GDMT Pillars Prescribed | ACE/ARB/ARNI | 28 Participants |
| Individual Tablets | Number of GDMT Pillars Prescribed | SGLT2i | 29 Participants |
| Individual Tablets | Number of GDMT Pillars Prescribed | MRA | 30 Participants |
| Polypill | Number of GDMT Pillars Prescribed | SGLT2i | 29 Participants |
| Polypill | Number of GDMT Pillars Prescribed | Beta Blocker | 30 Participants |
| Polypill | Number of GDMT Pillars Prescribed | ACE/ARB/ARNI | 28 Participants |
| Polypill | Number of GDMT Pillars Prescribed | MRA | 29 Participants |
Secondary
Number of Participants Completing a Qualitative Exit Interview
Participation in a semi-structured exit interview using a RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance)
Time frame: After study completion (between 8 and 12 weeks)
Population: All participants who completed both arms of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individual Tablets | Number of Participants Completing a Qualitative Exit Interview | 27 Participants |
Secondary
Total Daily Pill Burden of the Patient
This will be calculated based on the patient's active medication list.
Time frame: The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.
Population: Included participants who had this measure for both study periods (polypill and individual tablets).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Individual Tablets | Total Daily Pill Burden of the Patient | 10 pills per day |
| Polypill | Total Daily Pill Burden of the Patient | 7 pills per day |
Secondary
Treatment Satisfaction Using the Treatment Satisfaction Questionnaire for Medication (TSQM 9)
TSQM scores range from 0 to 100, with higher scores indicating greater treatment satisfaction.
Time frame: The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.
Population: Included participants who had this measure for both study periods (polypill and individual tablets).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Individual Tablets | Treatment Satisfaction Using the Treatment Satisfaction Questionnaire for Medication (TSQM 9) | 69.0 Points on Global Satisfaction Score |
| Polypill | Treatment Satisfaction Using the Treatment Satisfaction Questionnaire for Medication (TSQM 9) | 73.6 Points on Global Satisfaction Score |
Secondary
Weight
Weight at baseline and study follow-up
Time frame: The outcome will be measured 1) following a month of polypill use, and 2) following a month of individual tablet use.
Population: Included participants who had this measure for both study periods (polypill and individual tablets).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Individual Tablets | Weight | 92.0 kg |
| Polypill | Weight | 93.0 kg |
Other Pre-specified
Feasibility of Adherence to Study Protocols
Successful completion of study related procedures for at least 20 participants (screening, randomization, drug allocation, follow-up procedures, retention, and transition to ongoing care)
Time frame: Assessed following study completion (approximately 1 year)
Population: Number consented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individual Tablets | Feasibility of Adherence to Study Protocols | 27 Participants |
Other Pre-specified
Feasibility of Recruitment
Number of months taken to recruit 30-40 people to consent to participate in the study
Time frame: Completion of recruitment within 1 year of initiating recruitment
Population: This includes all participants who consented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Individual Tablets | Feasibility of Recruitment | 6 months |