heart faliure heart failure, polypharmacy, elderly
Conditions
Interventions
This study implements a comprehensive medication management program for patients in the intervention group. This program consists of: 1) Reducing or discontinuing inappropriate medications, primarily
2) Medication counseling (at baseline and after 2 or 4 months)
3) Reducing the number of daily doses
4) Using combination medications
5) Switching from regular to as-needed medications
6) Unit-dose packaging
7) Strengthening GDMT. No pharmaceuticals, medical devices, or medical supplies beyond those covered by insurance will be used.
Sponsors
Obokata Masaru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 18 years or older at the time of consent acquisition 2) Patients with heart failure 3) Patients taking five or more regular oral medications 4) Patients for whom written consent for study participation is obtained from the individual
Exclusion criteria
Exclusion criteria: 1) Patients for whom the physician clinically determines that the ASK-20 is difficult to administer due to cognitive impairment 2) Patients with comorbid conditions other than heart failure whose prognosis is less than six months 3) Patients participating in other interventional trials 4) Other patients deemed ineligible by the physician's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ASK-20 scores from baseline to 6 months post-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adherence rate over the most recent month (28 days) at 6 months 2. Changes in total barrier count from baseline to 6 months 3. Incidence of greater than or equal to 30% decline in eGFR, hyperkalemia (K greater than or equal to 5.5 mEq/L or initiation of a potassium binder), or hypokalemia (K <3.0 mEq/L) within 6 months 4. Changes in NT-proBNP levels from baseline to 6 months 5. Incidence of greater than 30% increase in NT-proBNP levels from baseline to 6 months 6. Changes in the GNRI from baseline to 6 months 7. All-cause mortality up to 12 months 8. Hospitalization for HF or unplanned visit requiring IV diuretics up to 12 months 9. Up-titration or initiation of loop diuretics up to 12 months 10. Composite endpoint of HF hospitalization, unplanned visit requiring IV diuretics, or up-titration or initiation of non-GDMT diuretics up to 12 months 11. Hospitalization up to 12 months caused by the following: fracture, fall, delirium/impaired consciousness, cognitive decline, syncope, bleeding, infection, malnutrition/appetite loss, electrolyte abnormalities, blood glucose abnormality, renal dysfunction, hepatic dysfunction, drug allergy, constipation/bowel obstruction, or drug-induced movement disorder 12. Adherence rate over the most recent month (28 days) at 12 months 13. Changes in the ASK-20 score from baseline to 12 months 14. Changes in total barrier count from baseline to 12 months 15. Incidence of greater than or equal to 30% decline in eGFR, hyperkalemia, or hypokalemia within 12 months 16. Changes in NT-proBNP levels from baseline to 12 months 17. Changes in the GNRI from baseline to 12 months 18. Identifying the optimal medication management strategy to maximize changes in ASK-20 using artificial intelligence | — |
Contacts
Public ContactKazuki Kagami
Gunma University Hospital
Outcome results
None listed