Trial document



drksid header

  DRKS00022339

Trial Description

start of 1:1-Block title

Title

Burden of disease of people with dementia in nursing homes measured by IPOS-Dem: a stepped-wedge cluster randomised controlled trial

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

IPOS-Dem

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

https://www.heds-fr.ch/media/2272/fiche_projet_ako_ipos-dem.pdf

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In this study, we check the IPOS-Dem instrument for its validity (1). Also, we check if there is a long-term effect on the burden of disease when using the IPOS-Dem Instrument in nursing homes. IPOS-Dem should be capable of recognising and prioritising all Symptoms and Needs of people with dementia. Highlighting those symptoms and needs helps to reduce the burden of disease. As far as we know, this is the first study into long-term effects of such a needs and symptom assessment for people with dementia in nursing homes.
GOALS:
*To reduce the burden of disease in people with dementia.
*To help the family frequently tell their understanding in an orderly way to nursing home staff.
*To improve the display of value and results from nursing care.
METHODS:
We include people with dementia, nursing staff of all qualification levels and family members. The study contains two interventions. All nursing homes will receive both interventions. Nurses and family members learn to use IPOS-Dem in the first intervention. During the second intervention, the staff gets coached in symptom management. The interventions inside the nursing homes last 17 months.
BACKGROUND:
People with dementia often suffer from more than one disease and symptoms. Often the symptoms and illnesses are not well treated. In turn, this leads to unnecessary suffering and stress, lowering the quality of life for people with dementia. Diversity among people with dementia and cognitive manifestations (e.g. impaired memory or communication) may lead to misinterpretation or dismissal of needs and symptoms. While swiss nursing homes use routine assessments like RAI or BESA for regular examination, documentation and tariff, only authorised nurses may utilise them. Validated holistic assessment instruments (e.g. IPOS-Dem) may support staff and family to reveal the needs of people with dementia.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This study will be conducted as a stepped wedge design (SW-CRT), involving two complex interventions for people with dementia in nursing homes. 13 nursing homes will be randomized in three steps. In three monthly intervals, 4-5 nursing homes will switch from the intervention 1 to the intervention 2 at given periods until all nursing homes are applying the intervention.
The study will train family members and nurses in nursing homes in their symptom assessment based on an instrument which is called IPOS-Dem (Integrated Palliative care Outcome Scale for Dementia). The training will include systematic observation training in assessing unmet needs of people with dementia (complex intervention no 1). Nurses will be also trained in symptom management (complex intervention no 2).

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

Dataset: Expected mid 2022, indexed and for download on https://zenodo.org/ (eventually embargoed, dependant on publisher)

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00022339
  •   2020/10/05
  •   [---]*
  •   yes
  •   Approved
  •   2019-01847, Kantonale Ethikkommission Zürich Stampfenbachstrasse 121 Postfach 8090 Zürich
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1254-4246 
  •   SNCTP000003941  (SNTCP)
  •   2019-01847  (BASEC-ID)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Dementia, Alzheimer
  •   F00 -  Dementia in Alzheimer disease
  •   F01 -  Vascular dementia
  •   F02 -  Dementia in other diseases classified elsewhere
  •   F03 -  Unspecified dementia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The study will train family members and nurses in nursing homes in their symptom assessment based on an instrument which is called IPOS-Dem (Integrated Palliative care Outcome Scale for Dementia). The training will include systematic observation training in assessing unmet needs of people with dementia (complex intervention no 1).
  •   Nurses will be also trained in symptom management (complex intervention no 2).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Supportive care
  •   Crossover
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Burden of disease (BOD):
The primary endpoint of this study is the reduction of burden of disease (BOD), measured with the total IPOS-Dem score (sum-score) in PwD compared to before and after the interventions. The primary endpoint will be assessed with the clinically relevant difference of 8 between baseline, and month 1-17.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

The secondary endpoint of this study is the improvement (= significant improvement of p<0.05) of Quality of life in PwD measured with the QUALIDEM outcome measure. The QUALIDEM will be measured every three months for 17 months. Longitudinal, total domain scores for PwD will be calculated and illustrated to demonstrate the quality of life trajectory.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Switzerland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/10/01
  •   260
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

(1) Nursing Homes (NH): at least 8 People with dementia (PWD), use BESA or RAI for Routine Assessment; (2) PWD: Diagnosed with Alzheimers' disease or vascular dementia OR Symptoms of Dementia documented in NH Records.; (3) Nursing Staff: At least 18 years old, employed in respective NH for at least three months with a quota equivalent to at least 20% (= working one day per week), speak german; (4) Relative: family member OR legal guardian of PWD fullfilling criteria listed above (2)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

(1) PwD, who are hospitalised during the recruitment phase and therefore not physically in the nursing home at the time of study start; (2) Relative: family member OR legal guardian of PWD fullfilling criteria listed above (1)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Heds FR, School of Health Professions
    • Ms.  Professor  Andrea Luise  Koppitz 
    • Route des Arsenaux 16a
    • 1700  Freiburg
    • Switzerland
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Heds FR, School of Health Professions
    • Mr.  Frank  Spichiger 
    • Route des Arsenaux 16a
    • 1700  Freiburg CH
    • Switzerland
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Heds FR, School of Health Professions
    • Ms.  Professor  Andrea Luise  Koppitz 
    • Route des Arsenaux 16a
    • 1700  Freiburg
    • Switzerland
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Heds FR, School of Health Professions
    • Ms.  Professor  Andrea Luise  Koppitz 
    • Route des Arsenaux 16a
    • 1700  Freiburg
    • Switzerland
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Schweizerische Akademie der Medizinischen Wissenschaften
    • Haus der Akademien, Laupenstrasse 7
    • 3001  Bern
    • Switzerland
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Gottfried und Julia Bangerter-Rhyner-Stiftung
    • Lange Gasse 15, Postfach
    • 4002  Basel
    • Switzerland
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.