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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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8 April 2024 |
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Main ID: |
DRKS00014279 |
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Date of registration:
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27/04/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Well informed physician patient communication in consultations on back pain
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Scientific title:
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Well informed physician patient communication in consultations on back pain - GAP |
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Date of first enrolment:
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01/09/2018 |
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Target sample size:
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1500 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00014279 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
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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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Sebastian
Voigt-Radloff |
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Address:
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Hugstetter Str. 49
79106
Freiburg
Germany |
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Telephone:
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+49 (0) 761 270 74470 (Sekretariat) |
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Email:
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sebastian.voigt@uniklinik-freiburg.de |
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Affiliation:
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Institut für Medizinische Biometrie und Statistik, Sektion Versorgungsforschung und Rehabilitationsforschung, Universitätsklinikum Freiburg, Medizinische Fakultät, Albert-Ludwigs-Universität Freiburg |
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Name:
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Piet
van der Keylen |
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Address:
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Universitätsstr. 29
91054
Erlangen
Germany |
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Telephone:
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09131-85-45771 |
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Email:
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piet.Keylen@uk-erlangen.de |
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Affiliation:
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Allgemeinmedizinisches Institut, Universitätsklinikum Erlangen |
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Key inclusion & exclusion criteria
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Inclusion criteria: Eligible are persons aged 18 years or older, insured by a company health insurance fund in Bavaria (BKK), presenting with back pain symptoms in a participating GP practice and providing written informed consent.
Exclusion criteria: Patients with insufficient German language skills to fill in the study questionnaires are excluded from the study.
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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M54.5
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Low back pain
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M54.5
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Intervention(s)
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Group 1: Usage of the GAP-portal during and after the consultation. The portal includes evidence-based, easy-to-understand and easy-to-use health information on low back pain.
Group 2: Treatment as usual in case of low back pain
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Primary Outcome(s)
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(1) Self-assessed knowledge of the patients on back pain and perceived information.
(2) Quality of physician-patient communication.
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Secondary Outcome(s)
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(3) self-reported self-efficacy regarding own communication behaviour; (4) health literacy; (5) pain intensity; (6) days of sick leave; (7) back pain related costs for the health care system.
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Source(s) of Monetary Support
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Innovationsausschuss beim Gemeinsamen Bundesausschuss
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Ethics review
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Status: Approved
Approval date: 27/02/2018
Contact:
ekfr.mpg@uniklinik-freiburg.de
Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
+49-761-27072600
ekfr.mpg@uniklinik-freiburg.de
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