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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: |
DRKS00014086 |
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Date of registration:
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26/02/2018 |
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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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Stay healthy - from the bottom of your heart
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Scientific title:
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Stay healthy - from the bottom of your heart - FBH |
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Date of first enrolment:
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26/02/2018 |
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Target sample size:
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1400 |
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Recruitment status: |
Pending |
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URL:
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http://drks.de/search/en/trial/DRKS00014086 |
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Study type:
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interventional |
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Study design:
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Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: No treatment / Standard of care; Assignment: parallel; Study design purpose:
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Phase:
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1
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Countries of recruitment
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Austria
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Germany
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Luxembourg
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Switzerland
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Contacts
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Name:
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Robert
Zieringer |
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Address:
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Theodor-W.-Adorno-Platz 6
60323
Frankfurt
Germany |
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Telephone:
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015774607212 |
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Email:
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zieringer.robert@gmail.com |
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Affiliation:
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Goethe Universität Frankfurt am Main |
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Name:
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Robert
Zieringer |
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Address:
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Theodor-W.-Adorno-Platz 6
60323
Frankfurt
Germany |
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Telephone:
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015774607212 |
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Email:
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zieringer@psych.uni-frankfurt.de |
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Affiliation:
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Goethe Universität Frankfurt am Main |
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Key inclusion & exclusion criteria
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Inclusion criteria: working at least 20h/week as an employee of an organization/company
Exclusion criteria: Conditions:
o Heart attack less than 5 years ago
o Angina pectoris
o Peripheral arterial disease
o chronic heart failure
Medication:
o Beta-Blocker
o Calciumantagonists
o Antidepressives
Age minimum:
16 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psychological Strain
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Intervention(s)
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Group 1: Short term psychosocial, health, legal, financial and elder care counseling provided by psychologists, medical doctors, lawyers, debt advisers and elder care experts.
The intervention is targeted towards sustaining and reestablishing the clients' work ability.
Counselling duration usually does not exceed 5h.
Group 2: no intervention
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Primary Outcome(s)
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Work Ability Index (WAI): beginning, before each counseling sessions, end, 6 month follow-up
Work Limitations Questionnaire (WLQ-8): beginning, end, 6 month follow-up
Health and Work Performance Questionnaire (HPQ): beginning, before each counseling sessions, end, 6 month follow-up
Absenteeism: beginning, before each counseling sessions, end, 6 month follow-up
Workforce Retention: end, 6 month follow-up
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Secondary Outcome(s)
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Heart Rate/Heart Rate Variability (HR/HRV): beginning, before each counseling sessions, end, 6 month follow-up
Job Satisfaction (ABB): beginning, end, 6 month follow-up
Work Engagement (UWES): beginning, end, 6 month follow-up
Work Accidents: beginning, end, 6 month follow-up
Need for Recovery (NFR): beginning, end, 6 month follow-up
Rumination (RRS-5): beginning, end, 6 month follow-up
Worrying (PSWQ-4): beginning, end, 6 month follow-up
Work Performance Appraisals: beginning, end, 6 month follow-up
Development of Chronic Diseases: end, 6 month follow-up
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Source(s) of Monetary Support
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Insite-Interventions GmbH
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Ethics review
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Status: Approved
Approval date: 18/01/2018
Contact:
Ethikkommission des Fachbereichs 5 Psychologie und Sportwissenschaften der Goethe Universität Frankfurt am MainVorsitzender: Prof. A. Klein, Goethe-Universität, Gebäude PEG, Abt. Methodenlehre [Ethikkommission des Fachbereiches 5 "Psychologie und Sportwissenschaften" der Goethe Universität]
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