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-WittenbergProfessor Dr. med. Michael GekleMagdeburger Straße 806112 HalleGermany
- 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-WittenbergProfessor Dr. med. Andreas KlementMagdeburger Straße 806112 HalleGermany
- 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-WittenbergProfessor Dr. med. Andreas KlementMagdeburger Straße 806112 HalleGermany
- 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-WittenbergProfessor Dr. med. Andreas KlementMagdeburger Straße 806112 HalleGermany
- 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 GmbHIndustriepark Höchst, K70365926 Frankfurt am MainGermany
- 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-AnhaltDoctor-Eisenbart-Ring 239120 MagdeburgGermany
- 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 239218 SchönebeckGermany
- 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-WittenbergMagdeburger Str. 1206112 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
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