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Note: This record shows only the 20 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.
Register: German Clinical Trials Register
Last refreshed on: 9 October 2017
Main ID:  DRKS00006081
Date of registration: 13/01/2015
Prospective Registration: No
Primary sponsor: Dekan der Medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg
Public 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)
Scientific 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) - BAIDIA II
Date of first enrolment: 15/11/2014
Target sample size: 120
Recruitment status: Recruiting
URL:  http://www.drks.de/DRKS00006081
Study type:  interventional
Study design:  Allocation: Randomized controlled trial;. Masking: Blinded (patient/subject). Control: Placebo. Assignment: Parallel. Study design purpose: Other;  
Phase:  N/A
Countries of recruitment
Germany
Contacts
Name: ***  ***
Address:  Magdeburger Straße 8 06112 Halle Germany
Telephone: ***
Email: 325352444465576541704958323537794c646363657952354c4a6d78716e32777a674968554649536d2b72565573666164615973582b7053585045775a466b63@drks.de
Affiliation:  Sektion AllgemeinmedizinMedizinische FakultätMartin-Luther-Universität Halle-Wittenberg
Name: ***  ***
Address:  Magdeburger Straße 8 06112 Halle Germany
Telephone: ***
Email: 325352444465576541704958323537794c646363657952354c4a6d78716e32777a674968554649536d2b72565573666164615973582b7053585045775a466b63@drks.de
Affiliation:  Sektion AllgemeinmedizinMedizinische FakultätMartin-Luther-Universität Halle-Wittenberg
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
E10 - Insulin-dependent diabetes mellitus
E11 - Non-insulin-dependent diabetes mellitus
Intervention(s)
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.
Primary Outcome(s)
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).
Secondary Outcome(s)
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)
Secondary ID(s)
2014-94
Source(s) of Monetary Support
Sanofi-Aventis Deutschland GmbH
Hausärzteverband Schsen-Anhalt e.V.
Kassenärztliche Vereinigung Sachsen-Anhalt
Secondary Sponsor(s)
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