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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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4 November 2019 |
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Main ID: |
DRKS00006081 |
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Date of registration:
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13/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Problems of care of elderly insulin-dependent diabetics in general practice - testing a standardised information system between general practices and care workers (BAIDIA II) - BAIDIA II |
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Date of first enrolment:
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15/11/2014 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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http://www.drks.de/DRKS00006081 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled trial;. Masking: Blinded (patient/subject). Control: Placebo. Assignment: Parallel. Study design purpose: Other;
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Andreas
Klement |
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Address:
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Magdeburger Straße 8
06112
Halle
Germany |
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Telephone:
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0345/5575338 |
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Email:
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andreas.klement@medizin.uni-halle.de |
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Affiliation:
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Sektion AllgemeinmedizinMedizinische FakultätMartin-Luther-Universität Halle-Wittenberg |
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Name:
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Andreas
Klement |
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Address:
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Magdeburger Straße 8
06112
Halle
Germany |
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Telephone:
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0345/5575338 |
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Email:
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andreas.klement@medizin.uni-halle.de |
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Affiliation:
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Sektion AllgemeinmedizinMedizinische FakultätMartin-Luther-Universität Halle-Wittenberg |
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Key inclusion & exclusion criteria
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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)
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
Age minimum:
65 Years
Age maximum:
no maximum age
Gender:
Both, male and female
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Health Condition(s) or Problem(s) studied
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E10 - Insulin-dependent diabetes mellitus
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E11 - Non-insulin-dependent diabetes mellitus
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Intervention(s)
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Intervention 1: 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. Intervention 2: 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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Primary Outcome(s)
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Amount of reported blood sugar lapses ( 20 mmol/l [ 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(s)
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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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Source(s) of Monetary Support
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Hausärzteverband Schsen-Anhalt e.V.
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Kassenärztliche Vereinigung Sachsen-Anhalt
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Sanofi-Aventis Deutschland GmbH
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Ethics review
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Status: approved
Approval date:
Contact:
(leading) Ethics Committee-No. (Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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