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| Name | Class |
|---|---|
| Universität des Saarlandes | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| regular, pharmacy-based intervention | Experimental | providing medication in weekly dosing aids and regular contacts with the local pharmacy |
|
| usual care | No Intervention | usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular, pharmacy based intervention | Behavioral | Regular, pharmacy-based intervention conducted in cooperation with the treating physician:
|
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence | Percentage of days covered (PDC) by prescribed medication and according to claims data | 12 months |
| Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause | Days lost due to unplanned cardiovascular hospitalizations or death of any cause | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Schulz, Prof. PhD | Federal Union of German Associations of Pharmacists | Study Chair |
| Ulrich Laufs, Prof. MD | Universitätsklinikum Leipzig | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saarland University | Homburg/Saar | 66421 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29846031 | Derived | Laufs U, Griese-Mammen N, Krueger K, Wachter A, Anker SD, Koehler F, Rettig-Ewen V, Botermann L, Strauch D, Trenk D, Bohm M, Schulz M. PHARMacy-based interdisciplinary program for patients with Chronic Heart Failure (PHARM-CHF): rationale and design of a randomized controlled trial, and results of the pilot study. Eur J Heart Fail. 2018 Sep;20(9):1350-1359. doi: 10.1002/ejhf.1213. Epub 2018 May 30. |
| Label | URL |
|---|---|
| PHARM-CHF study home page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
|
| FG001 | Usual Care | usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Medication Adherence | Percentage of days covered (PDC) by prescribed medication and according to claims data | Patients for whom we were able to calculate a PDC. | Posted | Mean | Standard Deviation | percentage of days covered | 12 months |
|
365 days and until end of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martin Schulz | ABDA, Department of Medicine | +49 30 40004-514 | arzneimittel@abda.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2019 | Mar 2, 2021 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 17, 2018 | Mar 2, 2021 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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|
| BG001 | Usual Care | usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Usual Care | usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group. |
|
|
| 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 | Posted | Mean | 95% Confidence Interval | days lost | 12 months |
|
|
|
| 8 |
| 110 |
| 0 |
| 110 |
| 0 |
| 110 |
| EG001 | Usual Care | usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group. | 8 | 127 | 0 | 127 | 0 | 127 |
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| D001519 | Behavior |