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

Organizational Data

DRKS-ID:
DRKS00006081
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2015-01-13
Last update in DRKS:
2017-10-18
Registration type:
Retrospective

Acronym/abbreviation of the study

BAIDIA II

URL of the study

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

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).

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.

Health condition or problem studied

ICD10:
E10 - Type 1 diabetes mellitus
ICD10:
E11 - Type 2 diabetes mellitus
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 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.
Arm 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.

Endpoints

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).
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)

Study Design

Purpose:
Other
Allocation:
Randomized controlled study
Control:
  • Placebo
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Doctor's practice Halle (Saale) und Umgebung

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2014-11-15
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
120
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
65 Years
Maximum Age:
no maximum age
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)

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

Addresses

Primary Sponsor

Address:
Dekan der Medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg
Professor Dr. med. Michael Gekle
Magdeburger Straße 8
06112 Halle
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Sektion AllgemeinmedizinMedizinische FakultätMartin-Luther-Universität Halle-Wittenberg
Professor Dr. med. Andreas Klement
Magdeburger Straße 8
06112 Halle
Germany
Telephone:
0345/5575338
Fax:
0345/5575340
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.medizin.uni-halle.de/index.php?id=1758&L=0&BF=0

Contact for Public Queries

Address:
Sektion AllgemeinmedizinMedizinische FakultätMartin-Luther-Universität Halle-Wittenberg
Professor Dr. med. Andreas Klement
Magdeburger Straße 8
06112 Halle
Germany
Telephone:
0345/5575338
Fax:
0345/5575340
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.medizin.uni-halle.de/index.php?id=1758&L=0&BF=0

Principal Investigator

Address:
Sektion AllgemeinmedizinMedizinische FakultätMartin-Luther-Universität Halle-Wittenberg
Professor Dr. med. Andreas Klement
Magdeburger Straße 8
06112 Halle
Germany
Telephone:
0345/5575338
Fax:
0345/5575340
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.medizin.uni-halle.de/index.php?id=1758&L=0&BF=0

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Address:
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst, K703
65926 Frankfurt am Main
Germany
Telephone:
0180/2222010
Fax:
0180/2222011
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.sanofi.de

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
Kassenärztliche Vereinigung Sachsen-Anhalt
Doctor-Eisenbart-Ring 2
39120 Magdeburg
Germany
Telephone:
(0391)6276000
Fax:
(0391)6278999
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.kvsa.de

Private sponsorship (foundations, study societies, etc.)

Address:
Hausärzteverband Schsen-Anhalt e.V.
Margaretenstraße 2
39218 Schönebeck
Germany
Telephone:
(03928)69170
Fax:
(03928)900555
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.hausaerzteverband-sachsen-anhalt.de/

Ethics Committee

Address Ethics Committee

Address:
Ethik-Kommission der Medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg
Magdeburger Str. 12
06112 Halle (Saale)
Germany
Telephone:
+49-345-5574476
Fax:
+49-345-5574477
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2014-07-10
Ethics committee number:
2014-94
Vote of the Ethics Committee:
Approved
Date of the vote:
2014-10-16

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry