Trial document




This trial has been registered retrospectively.
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  DRKS00022467

Trial Description

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Title

Digital IRENA - Sustainable therapeutic success and a comprehensive aftercare offer with the help of a multimodal telerehabilitation app

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Trial Acronym

digIRENA

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URL of the Trial

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Brief Summary in Lay Language

One aim of pension insurance is to make people independent again after a health impairment and thus help them to restore or maintain their ability to work. In many cases, however, pure rehabilitation measures are not yet sufficient to ensure the success of treatment. For this reason, the German pension fund (Deutsche Rentenversicherung) has launched the IRENA model (Intensive Rehabilitation Aftercare), which allows the success of the therapy to be ensured retrospectively. One problem with this model, however, is that it is limited in time and place, which makes regular participation more difficult. For this reason, the idea of closing this gap in care with a digital telerehabilitation aftercare programme was born. The aim of the study is to test a digital aftercare program in combination with outsourced therapeutic care and to examine its effectiveness with regards to work ability, subjective health, motivation, and drop-out rates in orthopedic rehabilitation patients. Furthermore, the aspects of practicability, user-friendliness and acceptance will be qualitatively examined.

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Brief Summary in Scientific Language

A mixed-method procedure is used to achieve the goals of the study. To assess the efficacy of the telerehabilitation program, four measurement times with three different groups are used in the quantitative assessment. A partial randomisation will be used to classify the patients into three groups: traditional aftercare, telerehabilitation care, control group. First the patients can choose whether they want to participate in the traditional aftercare. Only if the patients deny this group, they will be randomly assigned into the telerehabilitation aftercare or the control group. The measurement times are when the patients are at the rehabilitation centre and 13, 26, and 43 weeks after they have left the centre. Validiated questionnaires will be used to investigate work ability (WAI), subjective health (SF-12), and motivation (BREQ-2). Furthermore, the drop-out rate will be assessed in the two aftercare programs. Finally, qualitative interviews with therapeuts as well as patients will be conducted to assess the practicability, user-friendliness, and acceptance of the telerehabilitation platform.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00022467
  •   2020/07/24
  •   [---]*
  •   yes
  •   Approved
  •   [---]*, Ethikkommission des Karlsruher Instituts für Technologie
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Secondary IDs

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Health Condition or Problem studied

  •   ORTHOPAEDIC DISEASE
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Interventions/Observational Groups

  •   Orthopaedic rehabilitation test persons - classic IRENA
  •   Orthopaedic rehabilitation test persons - digIRENA
  •   Orthopaedic rehabilitation test persons - control group
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Characteristics

  •   Interventional
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  •   Other
  •   Open (masking not used)
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  •   Active control (effective treament of control group), Control group receives no treatment
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The study includes 4 measurement times:

1) t0 takes place during the stay at the rehabilitation centre and assesses the baseline scores.
2) t1 takes place 13 weeks after the patient has left the rehabilitation centre
3) t2 takes place 26 weeks after the patient has left the rehabilitation centre
4) t3 takes place 43 weeks after the patient has left the rehabilitation centre

At all measurement times, work ability (WAI), subjective health (SF-12) and motivation (BREQ-2) are assessed. In addition, the drop-out rates of the two aftercare programs are assessed from t1 onwards.

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Secondary Outcome

The study also includes interviews with different groups of test persons - patients and therapists - which are conducted between t0 and t3 with the aim of testing the user friendliness, practicability and acceptance of the users.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2019/11/22
  •   1150
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Orthopaedic injuries.
Need for an IRENA measure.

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Exclusion Criteria

Lack of basic knowledge of German

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Addresses

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    • Deutsche Rentenversicherung Knappschaft-Bahn-See
    • Pieperstr. 14-28
    • 44789  Bochum
    • Germany
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    • Karlsruher Institut für Technologie Institut für Sport und Sportwissenschaft
    • Mr.  Prof. Dr.  Darko  Jekauc 
    • Engler-Bunte-Ring 15
    • 76131  Karlsruhe
    • Germany
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    • Karlsruher Institut für Technologie Institut für Sport und Sportwissenschaft
    • Mr.  Julian  Fritsch 
    • Engler-Bunte-Ring 15
    • 76131  Karlsruhe
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Arbeit und Soziales
    • Rochusstraße 1
    • 53123  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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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.