Trial document




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  DRKS00004915

Trial Description

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Title

Pharmaceutical Care of patients during and after hospitalisation for Acute Coronary Syndrome

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Trial Acronym

PHAIRPLAY

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Our main attempt is to investigate, to which extent patients who suffered a heart attack can benefit from additional counselling by a pharmacist within and after their hospital stay. Beside, we would like to find out, how the patients' health state develops as well as how they are able to cope with their medical therapy during the first year after their heart attack.
In order to answer these questions, we offer the opportunity to patients who suffered a heart attack to take part in our study at the Clinic for Cardiology & Angiology of Hanover Medical School:
Patients who will be chosen for our Innovative Study Group by lot receive, in addition to the standard care by physicians, couselling by a pharmacist concerning their medication before being discharged. In the course of one year, two follow-up interviews will take place, i.e. after 6 and 12 months, respectively, which will be conducted via telephone. During these interviews, additional counselling will be offered, and, at the same time, data relevant to the study will be collected.
Being chosen by lot for the Traditional Study Group, these patients will exclusively experience care by medical staff. Study data will be collected - equally to the Innovative Study Group - during the patient's stay in hospital as well as during two telephone interviews after 6 and 12 months, respectively.
In our study, neither any physical examinations will take place nor any new drugs will be tested.

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Brief Summary in Scientific Language

In our study, we aim to evaluate the benefit of pharmaceutical care for patients who suffered an acute coronary syndrome by performing a randomised controlled interventional trial. Additionally, the current state of drug supply for these patients will be researched.
As patient outcomes are considerably impaired within the first year after index hospitalisation, a multimodal intersectoral intervention for boosting patients' adherence and persistence was tailored to the needs of this patient collective. The study is to reveal the extent up to which pharmaceutical care contributes to an ameliorated patient outcome.

Core intervention of our programme is an in-patient counselling session. Futhermore, patients of the intervention group will be provided with additional couselling within the follow-up after 6 and 12 months post-discharge, respectively. However, patients of the control group receive care and couselling by physicians only.
Endpoint will be assessed by patient-reported outcomes. Primary endpoint is the patient-reported medication adherence, while health-related quality of life serves as key secondary endpoint.

Data will be collected by use of standardised psychometric instruments. As by default no medical out-patient follow-up care is provided, the follow-up will be conducted in a remote mode via telephone as well as being merged with the follow-up intervention in the case of the intervention group.

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Organizational Data

  •   DRKS00004915
  •   2013/05/10
  •   [---]*
  •   yes
  •   Approved
  •   1784-2013, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Acute Coronary Syndrome, i.e. STEMI or NSTE-ACS
  •   I21 -  Acute myocardial infarction
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Interventions/Observational Groups

  •   Patients of the intervention group receive intersectoral pharmaceutical care: detailled pre-discharge counselling according to a multimodal concept serves as main intervention. Further counselling is offered during the follow-up telephone calls after 6 and 12 moneths, respectively. In-patient and out-patient care by physicians remains completely unaffected by the interventions.
  •   Patients of the control group will be cared of solely by physicians. Follow up telephone calls only serve to collect data.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Patient-reported medication adherence 12 months post-discharge as measured by the German Version of the Morisky Medication Adherence Scale / 8-item Version

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Secondary Outcome

Key secondary endpoint: patient-reported physical functioning as key dimension of health-related quality of life, as measured with the German Version of the Physical Funktioning Scale of the SF-12v2® Health Survey 12 months post-discharge.

Further secondary endpoints:
A. MACCE incidence: incidence and time up to a possible major adverse cardiac or cerebrovascular event during follow-up, i.e. non-fatal reinfarction, any repeat target lesion revascularisation (TLR), cerebrovascular accident or cardiac death.
B. Patient's diesease and drug related knowledge: essential content of the in-patient educative session will be assessed with a short self-designed questionnaire at discharge.
C. Patient satisfaction: satisfaction with drug related counselling will also be assessed at discharge unsing the drug information scale of the German Hamburger Fragebogen zum Krankenhausaufenthalt.
D. Health-related quality of life in the dimensions Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health as measured by the SF-12v2® Health Survey 12 months post-discharge.
E. Categorial interpretation of medication adherence: patient-reported medication adherence 12 months post-discharge will be interpreted according to the adherence categories by Morisky et al.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/05/27
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

a. patients 18 yrs. of age or older
b. acute coronary syndrome as confirmed admission diagnosis, i.e. st-segment elevated myocardial infarction (STEMI), non st-segment elevated myocardial infaction (NSTEMI) or unstable angina pectoris (UA).
c. informed consent

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Exclusion Criteria

a. restricted cognitive abilities, i.e. patients who are not able to care for themselves (patients with neurological/psychiatric disorders, patients receiving care or live in a nursing home)
b. patients with terminal renal impairment who receive blood dialysis regularly
c. patients under antineoplastic treatment
d. patients not capable of sufficient knowledge of German language

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Kardiologie & Angiologie der Medizinischen Hochschule Hannover
    • Mr.  Prof. Dr. med.  Andreas  Schäfer 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Institut für Biometrie der Medizinischen Hochschule Hannover
    • Mr.  Theodor  Framke 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Jan  Fodor 
    • OE 8500, Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Jan  Fodor 
    • OE 8500, Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Zentralapotheke der Medizinischen Hochschule Hannover
    • Ms.  Dr. rer. biol. hum.  Heike  Alz 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   [---]*
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Trial Publications, Results and other Documents

  •   Krankenhauspharmazie 34(4): 201-2 (2013).
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* This entry means the parameter is not applicable or has not been set.