Trial document




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  DRKS00014300

Trial Description

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Title

Adaptation of a mobile-based intervention to improve mental health and promote positive health behavior in patients after acute coronary syndrome

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Trial Acronym

MBI+PSY

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URL of the Trial

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Brief Summary in Lay Language

The aims of the study are to determine the effectiveness and acceptance of an SMS-based intervention on a German-speaking sample of patients after a heart attack and to calculate initial observations of various measures of psychological well-being (including anxiety, depression and optimism) and health behaviour (including physical activity). Participants recruited in cardiology will receive a short SMS every day for 14 days to encourage them to do exercises or give advice based on the concept of positive psychology.

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Brief Summary in Scientific Language

Objectives of this pilot study are to investigate the feasibility based on the assessments of participants of the mobile-based intervention (PACT - Promoting Activity in Cardiac Patients via text messages) in a German-speaking sample of patients afteran acute coronary syndrome (ACS). In addition to that, the aim is to provide observations of the course of self-reported data of various measures of psychological well-being (including anxiety, depression and optimism) and health behavior (including physical activity). Appropriate patients will receive a short text message every day for a period of 14 days asking them to perform exercises. The exercises are based on the concept of positive psychology and are complemented by advice and recommendations from the European Society of Cardiology (ESC).

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Organizational Data

  •   DRKS00014300
  •   2018/03/16
  •   [---]*
  •   yes
  •   Approved
  •   2018-13053-KliFo, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   I21 -  Acute myocardial infarction
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Interventions/Observational Groups

  •   All participants will receive over 14 days daily a text message on their mobile phone asking them to perform exercises or receive advice and recommendations from the European Society of Cardiology. The exercises are based on the concept of positive psychology. The participants are interviewed before, at the end and two weeks after the intervention by means of a telephone interview on the use and acceptance of the intervention as well as on health and psychological measures.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Before, at the end and two weeks after the intervention, a telephone interview with the study participants is conducted .

Utilization and acceptance of the mobile-based intervention (Likert scale of 0-5, how useful specific text messages and their contents were, evaluation of the frequency of text messages and the duration of the program, if necessary indicating an "ideal" frequency and duration, question, whether one or more several text messages led to a specific change of action)

At the end of the third telephone interview, study participation is over.

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Secondary Outcome

Secondary outcome criteria are the psychological well-being (0 - 10 Likert scale assessment of positive (happiness / satisfaction, optimism and determination) and negative (General health, depression, anxiety) psychological factors) and the physical activity (two items ask extent and duration of physical activity) of the subjects.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/05/17
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

-Acute coronary Syndrom
-Treated in the cardiology of the Johannes Gutenberg-University Mainz
-Consent declaration for participation
-Owner of a mobile phone

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Exclusion Criteria

-Severe physical or cognitive impairments
-Severe psychological diseases
-Insufficient german language skills

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Addresses

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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie der Universitätsmedizin Mainz
    • Untere Zahlbacher Str.8
    • 55131  Mainz
    • Germany
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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie,Universitätsmedizin der Johannes Gutenberg Universität Mainz
    • Mr.  Dipl.-Psych. Dr.  Rüdiger  Zwerenz 
    • Untere Zahlbacher Str. 8
    • 55131  Mainz
    • Germany
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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Ms.  M.Sc.Psych.  Carlotta  Baumgarten 
    • Untere Zahlbacher Str. 8
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Inneruniversitäre Forschungsförderung der Johannes Gutenberg-Universität Mainz
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/11/16
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Trial Publications, Results and other Documents

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