Trial document




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  DRKS00015493

Trial Description

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Title

Study on intensified nutritional counseling in patients during and after inpatient geriatric rehabilitation using a digital food diary and sensors for activity and body composition measurement for documentation in the DiDiER project

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Trial Acronym

DiDiER-EBFrail

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URL of the Trial

https://www.didier-projekt.de/wp/

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Brief Summary in Lay Language

Due to the increasing digitization, computer programs are also widely used in the field of nutritional counseling to support the counseling process. For the target group of older persons is known that they use and inquire little technology compared to young people. Furthermore for seniors receiving treatment in geriatric rehabilitation, it is known that malnutrition is widespread among them and that it can negatively affect the rehabilitation outcome, which requires effective nutritional counseling. It is to be examined to what extent intensified nutritional counseling is an advantage for the standard treatment in a rehabilitation center and to what extent a support through a digital food diary and through activity-measuring sensors is possible. The primary goal of the study-related measures is to increase the protein intake by at least 8 g / day.

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Brief Summary in Scientific Language

Malnutrition has a high prevalence in geriatric rehabilitation and may negatively affect the outcome of rehabilitation. The extent to which the nutritional status of seniors in geraitic rehabilitation can be improved by intensifying counseling and a parallel documentation supported by technology is to be investigated in a randomized controlled trial. The target population are consecutively admitted patients undergoing inpatient geriatric rehabilitation, aged 70 years or older, who are affected by malnutrition or related risk factors such as weight loss, underweight or reduced food intake. Subjects in the intervention group receive 5 counseling sessions and document their consumption and activity with a food diery and sensors respectively while subjects in the control group receive standard care of the rehabilitation center consisting of one-time counseling and a nutritional lecture. The main target criterion is the change in protein intake in g / day and g / kg / day over a period of 2 months beyond the end of the rehabilitation.

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Organizational Data

  •   DRKS00015493
  •   2018/12/11
  •   [---]*
  •   yes
  •   Approved
  •   2018-105, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Geriatric rehabilitation patients with malnutrition according to Mini Nutritional Assessment short form or the risk factors weight loss, reduced food intake or underweight
  •   E46 -  Unspecified protein-energy malnutrition
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Interventions/Observational Groups

  •   Intervention group: Intensified nutritional counseling consisting of 5 counseling units, 2 in geriatric rehabilitation and 3 after discharge from rehabilitation. Documentation of food intake via a food diary app and the activity with a smart watch and a sensor belt.
  •   Control group: Standard care of the rehab consisting of a one-time nutritional counseling and a nutrition lecture.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Delta protein intake g/day: Protein intake g/day t5 - protein intake g/day t1
t5= 2 month follow-up after discharge from rehab,
t1= at beginning of rehab

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Secondary Outcome

Change in energy, macro and micronutrient intake, body composition, body weight, MNA-SF score, fractile status, number of steps, detected sensor belt activity over the period t1-t5

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/01/18
  •   36
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Consecutive admission to the geriatric rehabilitation unit of the Rehazentrum Oldenburg,
Age ≥70 years, malnutrition according to MNA-SF (0-7 points), or the following risk factors for malnutrition: weight loss in the last 3 months, decreased food intake in the last 3 months, or decreased BMI (<23kg / m²),
prescription of nutritonal counseling

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Exclusion Criteria

Inability to understand the study content and course of study due to reduced cognitive status or language barriers, participation in another study, place of residence is further than 30 km away from Oldenburg

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Addresses

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    • Offis - Insitut für Informatik
    • Mr.  Prof. Dr.-Ing.  Andreas  Hein 
    • Escherweg 2
    • 26121  Oldenburg
    • Germany
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    • Abteilung für Assistenzsysteme und Medizintechnik, Department für Versorgungsforschung, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg
    • Ms.  M Sc Ernährungswissenschaften  Julia  Wojzischke 
    • Ammerländer Heerstraße 140
    • 26129  Oldenburg
    • Germany
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    • Abteilung für Assistenzsysteme und Medizintechnik, Department für Versorgungsforschung, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg
    • Ms.  M.Sc.  Julia  Wojzischke 
    • Ammerländer Heerstraße 140
    • 26129  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  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.