Trial document




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  DRKS00011802

Trial Description

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Title

Dysphagia therapy in the elderly: Weighing aspiration risk against quality of life in eating and drinking.
Which relevant aspects for decisions can be deducted from the patients’ and family members’ perspectives?
A qualitative pilot study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Swallowing therapy in the elderly suffering from multiple illnesses is embedded in a complex personal and medical situation. The modification of food and fluids to reduce the risk of aspiration pneumonia is a common instrument in swallowing therapy.
In daily clinical experience limitations concerning acceptance and feasibility of food modification become obvious. Swallowing therapy in a geriatric setting thus needs a careful adaptation of food consistency restrictions with regard to the general goals of geriatric treatment ranging from healing to maximizing quality of life.
Until now, there is little information on shared decision making by speech language therapists (SLPs) and patients in a geriatric setting which concerns the balancing of aspiration risk versus quality of life in case of eating and drinking.
The purpose of this study is to find out which aspects are important for patient and their closest family member when weighing aspiration risk against quality of life from eating and drinking.
Data are collected through interviews. Respectively one patient and the associated family member will both be interviewed separately. The patients registered for this study need to be capable of giving consent, have to have mild to severe swallowing difficulties, and need to have experience of at least one week with pureed or semi-solid food. Results from routinely performed endoscopic assessments of swallowing are included for the evaluation of aspiration risk, i.e. how likely is it that food and fluids might enter the lower airways.
Finally, the interviews will be transcribed into written text which will then be analysed.

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Brief Summary in Scientific Language

Dysphagia therapy in the elderly suffering from multimorbidity is embedded in a complex personal and medical situation. The modification of food and fluids to reduce the risk of aspiration pneumonia is a common instrument in dysphagia therapy.
In daily clinical experience limitations concerning acceptance and feasibility of food modification become obvious. Dysphagia therapy in a geriatric setting thus needs a careful adaptation of food consistency restrictions with regard to the general goals of geriatric treatment ranging from healing to maximizing quality of life.
Until now, there is little information on shared decision making by speech language therapists and patients in a geriatric setting which concerns the balancing of aspiration risk versus quality of life in case of oral nutrition.
The purpose of this qualitative study is to determine first important aspects of the patients’ and family members’ perspectives in decision making when balancing aspiration risk against quality of life from eating and drinking.
Data are collected through semi-structured, problem centered interviews. Respectively one patient and the associated family member will both be interviewed separately. The patients registered for this study need to be capable of giving consent, have to have mild to severe swallowing difficulties, and need to have experience of at least one week with pureed or semi-solid food. Results from routinely performed video-endoscopies of swallowing are included for the evaluation of aspiration risk.
Finally, the interviews will be transcribed into written text which will then be analysed.

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Organizational Data

  •   DRKS00011802
  •   2017/03/06
  •   [---]*
  •   yes
  •   Approved
  •   S-590/2016, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   R13.9 -  [generalization R13: Dysphagia]
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Interventions/Observational Groups

  •   The study includes geriatric patients suffering from multimorbidity who are able to give consent. Patients need to suffer from mild to severe dysphagia but are capable of oral nutrition. They are in-patients at the AGAPLESION Bethanien Krankenhaus, either in an acute or rehabilitative setting. Both, patients and family members, take part in a semi-structured interview.
    Contents of the interview:
    -Adaption of food and fluids
    -Risks
    -Quality of life
    -Decisions concerning risks versus quality of life
    -Concepts for making decisions
    -Relevance of age
    -Self perception
    -Importance of dysphagia
    -Role of spouse / family
    -Personality
    -Coping strategies
    -Dilemma
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Determination of relevant aspects from the perspective of geriatric patients with dysphagia and their family members concerning decisions between aspiration risk and quality of life from eating and drinking.
Data are collected through semi-structured, problem centered interviews. Respectively one patient and the associated family member will both be interviewed separately.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/03/01
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients/ Family Members of AGAPLESION Bethanien Krankenhaus Heidelberg
Patients of SLP colleagues
Cognitive abilities of patients: Mini Mental State ≥ 24
Dysphagia: GUSS* ≤ 19
At least one week pured or semi-solid food during the stay
NTID** ≥ 3, speech essentially understandable
Acute or rehabilitative geriatric treatment within the frame of multimorbidity
Age ≥ 75

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Exclusion Criteria

Patients at other institutions
Lack of family members
Patients with legal representatives
Patients of the investigator responsible for the study
Mini Mental State < 24
GUSS ≥ 20
Oral nutrition with solid consistencies (more than semi-solid)
Nil by mouth
NTID ≤ 2, speech mostly or totally incomprehensible
Aphasia
Age < 75

* GUSS = Gugging Swallowing Screen (Trapl, 2007)
** NTID = Comprehensibility scale, National Technical Institute for the deaf. (Ziegler, 1994)

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Addresses

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    • AGAPLESION Bethanien Krankenhaus Heidelberg
    • Ms.  Katja   Emmerich 
    • Rohrbacher Straße 149
    • 69126  Heidelberg
    • Germany
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    • AGAPLESION Bethanien Krankenhaus Heidelberg - Abteilung Logopädie
    • Ms.  Katja  Emmerich 
    • Rohrbacher Straße 149
    • 69126  Heidelberg
    • Germany
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    • AGAPLESION Bethanien Krankenhaus Heidelberg - Abteilung Logopädie
    • Ms.  Katja  Emmerich 
    • Rohrbacher Straße 149
    • 69126  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • AGAPLESION Bethanien KrankenhausAbteilung Logopädie
    • Ms.  Katja  Emmerich 
    • Rohrbacher Straße 149
    • 69126  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/05/31
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Trial Publications, Results and other Documents

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