Trial document



drksid header

  DRKS00003554

Trial Description

start of 1:1-Block title

Title

Development of a quality-tested patient decision aid for lowering cardio-vascular risk

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

QEH-CVR

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Cardiovascular diseases are the leading causes of death in industrialised nations. High blood pressure and unhealthy lifestyle (smoking, physical inactivity, obesity and excessive alcohol consumption) increase the risk of heart attack or stroke, particularly in combination with additional risk factors such as family history and diabetes mellitus. Lifestyle changes and medical adherence can lower cardiovascular risk. Active patient participation is needed for a higher level of treatment adherence. Decision aids facilitate patients’ understanding of the disease and available therapies, thus empowering patients so as to enhance their participation in medical decision making.
The aim of this study is to develop an evidence-based decision aid to decrease cardiovascular risk. The decision aid will be designed as a booklet which may be used in addition to a cardiovascular risk calculator. The decision aid will contain information on evidence-based treatment options (including their advantages and disadvantages) to reduce cardiovascular risk. Additionally it includes worksheets which support patients in weighting their preferences and in implementing lifestyle changes. Furthermore, the decision aid is to stimulate patients and their general practitioners to develop an individual treatment plan with realistic goals. The goals should be discussed and, if necessary, adapted in the following consultations.
The evidence-based decision aid will be elaborated according to the International Patient Decision Aid Standards (IPDAS). In a structured multi-step process, involving experts and patients, qualitative and quantitative methods will be applied including (1) expert evaluations, (2) focus groups with experts and patients, (3) questionnaire survey, and (4) final expert rating.

Future research is needed to verify the practical application and effectiveness of the decision aid.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Cardiovascular diseases are the leading causes of death in industrialised nations. High blood pressure and unhealthy lifestyle (smoking, physical inactivity, obesity and excessive alcohol consumption) increase the risk of heart attack or stroke, particularly in combination with additional risk factors such as family history and diabetes mellitus. Lifestyle changes and medical adherence can lower cardiovascular risk. Active patient participation is needed for a higher level of treatment adherence. Decision aids facilitate patients’ understanding of the disease and available therapies, thus empowering patients so as to enhance their participation in medical decision making.
The aim of this study is to develop an evidence-based decision aid to decrease cardiovascular risk. The decision aid will be designed as a booklet which may be used in addition to a cardiovascular risk calculator. The decision aid will contain information on evidence-based treatment options (including their advantages and disadvantages) to reduce cardiovascular risk. Additionally it includes worksheets which support patients in weighting their preferences and in implementing lifestyle changes. Furthermore, the decision aid is to stimulate patients and their general practitioners to develop an individual treatment plan with realistic goals. The goals should be discussed and, if necessary, adapted in the following consultations.
The evidence-based decision aid will be elaborated according to the International Patient Decision Aid Standards (IPDAS). In a structured multi-step process, involving experts and patients, qualitative and quantitative methods will be applied including (1) expert evaluations (thinking aloud method), (2) focus groups, (3) questionnaire survey, and (4) final expert rating.

Future research is needed to verify the practical application and effectiveness of the decision aid.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003554
  •   2012/09/27
  •   [---]*
  •   yes
  •   Approved
  •   39/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I10-I15 -  Hypertensive diseases
  •   I25.0 -  Atherosclerotic cardiovascular disease, so described
  •   I73.9 -  Peripheral vascular disease, unspecified
  •   E10-E14 -  Diabetes mellitus
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Development of an evidenced-based decision aid for patients to decrease cardiovascular risk by involving experts and patients.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Development of an evidence-based decision aid for patients to decrease cardiovascular risk.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Acceptance of the decision aid by patients and general practitioners. Evaluation by survey and expert rating

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
  • other 
  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/10/24
  •   45
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients: high cardiovascular risk
Minimum age: 18 years.
Experts: Practitioners or scientists with high knowledge about evidence based medicine regarding cardiovascular diseases, health behavior, and shared decision making.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Patients: Limits of understanding because of mental diseases or insufficient language skills or Patients with serious illness and/or short life expectancy. Pregnant women.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik Freiburg Lehrbereich Allgemeinmedizin
    • Ms.  M.A.  Iris  Tinsel 
    • Elsässer Straße 2m
    • 79110  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinik Freiburg Lehrbereich Allgemeinmedizin
    • Ms.  M.A.  Iris  Tinsel 
    • Elsässer Straße 2m
    • 79110  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinik Freiburg Lehrbereich Allgemeinmedizin
    • Ms.  M.A.  Iris  Tinsel 
    • Elsässer Straße 2m
    • 79110  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg. Nachwuchsförderung Versorgungsforschung Baden-Württemberg
    • Königstraße 46
    • 70173  Stuttgart
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/04/08
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.