Trial document





This trial has been registered retrospectively.
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  DRKS00006081

Trial Description

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Title

Problems of care of elderly insulin-dependent diabetics in general practice - testing a standardised information system between general practices and care workers (BAIDIA II)

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Trial Acronym

BAIDIA II

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URL of the Trial

http://web.uk-halle.de/index.php?id=5127

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Brief Summary in Lay Language

The BAIDIA I enquiry showed that between general practitioners, medical assistants and care workers remarkable mutual information deficits prevail in view of therapy aims, therapy instructions (e.g. insulin schemes and insulin doses), therapy follow-up, report intervals and indications for mutual sharing of information as well as home visits.
A format for a systematic ensuring of understanding as well as a covering of therapy aims respectively power to act is needed.
Such a format for a standardised exchange of information could be (with a positive evaluation and broader implementation) a relevant indicator for remuneration of structural quality in selective or collective treatment contracts between general practitioners, care workers and medical insurance companies in the future.
Therefore the pilot study BAIDIA II not only foculises on clinical relevant endpoints of diabets bt also on the improvement of actual treatment reality older type 2 diabetics, inter-professional approach to therapy options and in view of interverntion on the communicative transfer of therapy management (doctor) to realised therapy and its possible complications (care).

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Brief Summary in Scientific Language

The prevalence of diabetes mellitus rises up to 20 percent in the age group of over 70 years old besides a demographic dependent proportion of geriatric patients at the general medical care.
While an intensive and complex diabetes therapy for non-geriatric patients is more beneficial for morbidity processes, an intensified diabetes therapy for geriatric patients is valued more often as complicated and since the ACCORD study more and more reluctant.
With the discussion about an adequate diabetes therapy for geriatric patients comes the question, how demands on an autonomous cooperation of this patient group can be realised, to the fore.
Since the insulin utilization and the daily dealing with the disease (diet, dining intervals etc.) ist not only ensured by the patients itself but by fostering people from domestic environment or professional care workers.
Guidelines for diagnostic and therapy of diabetes can not unconditional be transferred on the observed geriatric clientele but require transmission into individualised guidance for patients and their fostering relatives resp. care workers.
The BAIDIA I study revealed, with the help of interviews with general practitioners, their medical assistants and professional care workers, mutual coordination- and information-needs between the involved occupational groups.
Especially care workers required appropriate insulin therapy-schemes with information about measurement-dependent dose-correction, general practitioners required prompt information about diabetes lapses and care- resp. supply-problems.
Therefore focuses the submitted follow-up study BAIDIA II on an enhancement of supply reality of older type 2 diabetics by the use of a standardised fax-based communication tool between care workers and general practitioners.

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Organizational Data

  •   DRKS00006081
  •   2015/01/13
  •   [---]*
  •   yes
  •   Approved
  •   2014-94, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

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

  •   E10 -  Insulin-dependent diabetes mellitus
  •   E11 -  Non-insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   Implementation of a standardised bilateral information system between family practices and care attendants (and vice versa) as an one-sided facsimile template (obligation of nonproliferation of the template).
    At the beginning of the study-implementation (t0) a product-neutral advanced training course, concerning insulin management and diabetes, will take place with at least 8 family practices.
  •   Implementation of an identic advanced training course concerning insulin management without the facsimile template at at least 8 family practices.
    Practices in the control group receive coded documentation templates and furthermore a facsimile template which informs the care attendants about the study in general, announces both an endpoint elicitation and patients' satisfaction questionnaire and urges alternating communication ("placebo" facsimile template).
    Cooperating care facilities/nursing services will be gathered and excluded if necessary in order to minimize contamination of the study arms by intergroup contact care attendants.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Amount of reported blood sugar lapses (< 4 or > 20 mmol/l [< 72 or > 360 mg/dl]] from care attandants to general practitioner at the time of 3 and 6 month after intervention (t1 + t2).

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Secondary Outcome

Amount of planned/unplanned home vistits by genaral practitioners and/or medical assistants

Amonut of diabetes caused hospital and/or specialist treatment (t0 + t1 + t2)

HbA1c values (t0 + t1 + t2)

Patients-/(relatives-) satisfaction (EUROPEP questionnaire) ( only t2)

Evaluation of quality of communication, patients safty and work simplification of the information system by general practitioners, medical assistants and care workers (only t2)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2014/11/15
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Age > 65 years
insulin-dependent diabetes mellitus type 1 and 2 (every kind of insulin regime blood sugar controls at least once a week)
being under general practitioner's care and care attandants' care (ambulant/stationary)

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Exclusion Criteria

Age ≤ 65 years
diabetes mellitus without insulin therapy or with blood sugar controls less than once a week
being under non-professionals' care (e.g. relatives)
unfavourable primary deseases with a life expectancy less than 6 months
risk of contamination by congruent identities of professional care attandents (nursering services, nursering homes) in intervention and control group
denial of disclosure of secundary data by the principal investigator

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Dekan der Medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg
    • Mr.  Professor Dr. med.  Michael  Gekle 
    • Magdeburger Straße 8
    • 06112  Halle
    • Germany
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    •   [---]*
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    • Sektion AllgemeinmedizinMedizinische FakultätMartin-Luther-Universität Halle-Wittenberg
    • Mr.  Professor Dr. med.  Andreas  Klement 
    • Magdeburger Straße 8
    • 06112  Halle
    • Germany
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    • Sektion AllgemeinmedizinMedizinische FakultätMartin-Luther-Universität Halle-Wittenberg
    • Mr.  Professor Dr. med.  Andreas  Klement 
    • Magdeburger Straße 8
    • 06112  Halle
    • Germany
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Sources of Monetary or Material Support

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    • Kassenärztliche Vereinigung Sachsen-Anhalt
    • Doctor-Eisenbart-Ring 2
    • 39120  Magdeburg
    • Germany
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    •   (0391)6276000
    •   (0391)6278999
    •   [---]*
    •   http://www.kvsa.de
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    • Sanofi-Aventis Deutschland GmbH
    • Industriepark Höchst, K703
    • 65926  Frankfurt am Main
    • Germany
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    • Hausärzteverband Schsen-Anhalt e.V.
    • Margaretenstraße 2
    • 39218  Schönebeck
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.