Chronic Heart FailurePHARM-CHFNCT01692119
Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure
A study testing Regular, pharmacy based intervention in people with Chronic Heart Failure, run by Federal Union of German Associations of Pharmacists at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Regular, pharmacy based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure (PHARM-CHF): A Randomized Controlled Trial
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.
- Conditions
- Chronic Heart Failure
- Being tested
- Regular, pharmacy based intervention
- Keywords
- chronic heart failure, medication adherence, pharmacy, interdisciplinary care, randomized controlled trial, mortality, hospitalization
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular, pharmacy based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| regular, pharmacy-based intervention | Experimental | providing medication in weekly dosing aids and regular contacts with the local pharmacy Receives: Behavioral: Regular, pharmacy based intervention |
| usual care | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Percentage of days covered (PDC) by prescribed medication and according to claims data
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Union of German Associations of Pharmacists
- Sponsor type
- University, hospital or other
- Collaborators
- Universität des Saarlandes
- Responsible party
- Sponsor
- Investigators
- Martin Schulz, Prof. PhD, Study chair, Federal Union of German Associations of PharmacistsUlrich Laufs, Prof. MD, Study chair, Universitätsklinikum Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692119
- Sponsor's protocol ID
- PHARM-CHF
- Acronym
- PHARM-CHF
- Status last verified
- Mar 2021
- First submitted
- 17 Sep 2012
- Last updated
- 22 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29846031
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure (PHARM-CHF): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01692119
- Acronym / sponsor ID
- PHARM-CHF / PHARM-CHF
- Conditions
- Chronic Heart Failure
- Keywords
- chronic heart failure, medication adherence, pharmacy, interdisciplinary care, randomized controlled trial, mortality, hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Federal Union of German Associations of PharmacistsUniversity, hospital or other
- Collaborators
- Universität des Saarlandes
- Study start
- Oct 2012 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Posted 26 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regular, pharmacy-based intervention | Experimental | Behavioral: Regular, pharmacy based interventionproviding medication in weekly dosing aids and regular contacts with the local pharmacy |
| usual care | No intervention | –usual care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Regular, pharmacy based interventionRegular, 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. | Behavioural | regular, pharmacy-based intervention |
Primary outcome
Medication Adherence
Time frame: 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
Time frame: 12 months
Days lost due to unplanned cardiovascular hospitalizations or death of any cause
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29846031Laufs 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.
- PHARM-CHF study home pageLink provided by the sponsor.
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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.
Martin Schulz, Prof. PhD study chair
Federal Union of German Associations of Pharmacists
Ulrich Laufs, Prof. MD study chair
Universitätsklinikum Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular, pharmacy based intervention in people with Chronic Heart Failure, run by Federal Union of German Associations of Pharmacists at 1 site in Germany.
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 5 inclusion and 6 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 22 Apr 2021. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 26 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Medication Adherence (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692119, which also lists 1 linked publication.
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 22 Apr 2021.