Chronic Heart Failure
Conditions
Keywords
chronic heart failure, medication adherence, pharmacy, interdisciplinary care, randomized controlled trial, mortality, hospitalization
Brief summary
The aim of the study is to investigate whether a continuous interdisciplinary intervention improves medication adherence (primary efficacy endpoint) and leads to a reduction of hospitalizations and mortality (primary safety endpoint) in elderly patients with chronic heart failure. The intervention, consisting of regular contacts with the local pharmacy and weekly dosing aids, aims to improve medication adherence and management.
Interventions
BEHAVIORALRegular, pharmacy based intervention
Regular, pharmacy-based intervention conducted in cooperation with the treating physician: * Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan. * Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.
Sponsors
Universität des Saarlandes
Federal Union of German Associations of Pharmacists
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: 60 years and older * Chronic heart failure (CHF) * Stable CHF medication including a diuretic * Hospitalization for decompensated heart failure within past 12 months OR a value of ≥ 350 pg/mL for BNP or ≥ 1,400 pg/mL for NT-proBNP * Written informed consent
Exclusion criteria
* Use of a weekly dosing aid * Unwillingness or inability to visit a participating pharmacy once a week * Planned cardiac surgery * Life-expectancy \< 6 months * Unwillingness or inability to comply with the study protocol (including drug abuse or alcohol dependency) * Participation in other studies (currently or in the last 4 weeks)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | 12 months | Percentage of days covered (PDC) by prescribed medication and according to claims data |
| Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause | 12 months | Days lost due to unplanned cardiovascular hospitalizations or death of any cause |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Regular, Pharmacy-based Intervention providing medication in weekly dosing aids and regular contacts with the local pharmacy
Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:
* Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.
* Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician. | 110 |
| Usual Care usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group. | 127 |
| Total | 237 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Intervention: pts. did not present to participating pharmacy | 17 | 0 |
| Overall Study | Protocol Violation | 3 | 1 |
Baseline characteristics
| Characteristic | Regular, Pharmacy-based Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 74.1 years STANDARD_DEVIATION 6.8 | 74.1 years STANDARD_DEVIATION 7.2 | 74.1 years STANDARD_DEVIATION 7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 42 Participants | 49 Participants | 91 Participants |
| Sex: Female, Male Male | 68 Participants | 78 Participants | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 110 | 8 / 127 |
| other Total, other adverse events | 0 / 110 | 0 / 127 |
| serious Total, serious adverse events | 0 / 110 | 0 / 127 |
Outcome results
Primary
Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause
Days lost due to unplanned cardiovascular hospitalizations or death of any cause
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Regular, Pharmacy-based Intervention | Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause | 24.8 days lost |
| Usual Care | Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause | 16.5 days lost |
Primary
Medication Adherence
Percentage of days covered (PDC) by prescribed medication and according to claims data
Time frame: 12 months
Population: Patients for whom we were able to calculate a PDC.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regular, Pharmacy-based Intervention | Medication Adherence | 91.2 percentage of days covered | Standard Deviation 11.9 |
| Usual Care | Medication Adherence | 85.5 percentage of days covered | Standard Deviation 16.6 |