Trial document

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DRKS-ID: DRKS00000683

Trial Description

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Title

Adult attachment and self management in patients with multimorbidity in primary care

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In an observation study with prospektiv design the connection between attachment styles and self management in primary care patients with multimorbidity will examine. The attachment theory has the potential to explain interindividual differences in illness from a developmental psychological perspective. 200 patients with 3 chronic illnesses, between 50-85 years from 8 GPs are examined after recruitment (baseline) and 12 months later. The classification of the attachment style occurs by selfmeasure instruments and interviews. The primary outcome is self management, the secondary outcome are drug compliance, quality of life, state of health and frequencies of medical contacts. The expected results can give a base for the development of interventions which are fitted on different patient's types.

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Brief Summary in Scientific Language

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Organizational Data

DRKS-ID: DRKS00000683
Date of Registration in DRKS: 2011/02/23
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 3009-12/10, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät

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Secondary IDs

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Health Condition or Problem studied

Free text: 3 chronical diseases (KHK, Diabetes II, Hypertonie)
ICD10: E11 - Non-insulin-dependent diabetes mellitus
ICD10: I10 - Essential (primary) hypertension
ICD10: I20 - Angina pectoris
ICD10: I21 - Acute myocardial infarction
ICD10: I25 - Chronic ischaemic heart disease

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Interventions/Observational Groups

Arm 1: observationalgroup 1: primary care patients were confered with questionnaires (interviews) baseline and follow up after 12 month

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Observational study
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Prognosis
Assignment: Single (group)
Phase: N/A
Off-label Drug use: [---]*

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Primary Outcome

Self Management (FERUS Jack)
Baseline and Follow up afer 12 month

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Secondary Outcome

Complicance (Morisky), Control Preference (CPS), Quality of life (SF 12), state of health (Euro Qol), Depression (PHQ-9), medical care, Baseline and Follow up afer 12 month

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2011/11/01
Target Sample Size: 200
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 50 Years
Maximum Age: 85 Years

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Additional Inclusion Criteria

>=3 chronic diseases, 50-85 years, in primary care, at least one contact with the GP in the last 3 month

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Exclusion Criteria

disability for an informed consent

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Addresses

Primary Sponsor
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- Institut für Allgemeinmedizin, Universitätsklinikum Jena
- Mr. Prof. Dr. med. habil., Dipl.-Päd.
- Bachstrasse 18
- 07743 Jena
- Germany
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- Telephone: 03641/9-39 58 00
- Fax: 03641/9-39 58 02
- E-mail: jochen.gensichen at med.uni-jena.de
- URL: http://www.allgemeinmedizin.uni-jena.de
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Contact for Scientific Queries
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- Institut für Allgemeinmedizin Universitätsklinikum Jena
- Ms. Dipl.-Psych. Katja Brenk-Franz
- Bachstrasse 15
- 07743 Jena
- Germany
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- Telephone: 03641/9-39 58 10
- Fax: 03641/9-39 58 02
- E-mail: katja.brenk-franz at med.uni-jena.de
- URL: http://www.allgemeinmedizin.uni-jena.de/content/team/katja_brenk_franz/index_ger.html
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Contact for Public Queries
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- Institut für Allgemeinmedizin des Universitätsklinikums Jena
- Ms. Dipl.-Psych. Katja Brenk-Franz
- Bachstrasse 15
- 07743 Jena
- Germany
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- Telephone: 03641/9-39 58 10
- Fax: 03641/9-39 58 02
- E-mail: katja.brenk-franz at med.uni-jena.de
- URL: http://www.allgemeinmedizin.uni-jena.de/content/team/katja_brenk_franz/index_ger.html
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Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
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- Institut für Allgemeinmedizin des Universitätsklinikums Jena
- Mr. Jochen Gensichen
- 07743 Jena
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.allgemeinmedizin.uni-jena.de
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Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.dfg.de
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Status

Recruitment Status: Recruiting complete, follow-up continuing
Study Closing (LPLV): [---]*

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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.