Burden of disease of people with dementia in nursing homes measured by IPOS-Dem: a stepped-wedge cluster randomised controlled trial
Organizational Data
- DRKS-ID:
- DRKS00022339
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2020-10-05
- Last update in DRKS:
- 2023-10-26
- Registration type:
- Retrospective
Acronym/abbreviation of the study
IPOS-Dem
URL of the study
https://www.heds-fr.ch/media/2272/fiche_projet_ako_ipos-dem.pdf
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 15 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.
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. 23 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).
Health condition or problem studied
- Free text:
- Dementia, Alzheimer
- ICD10:
- F00 - Dementia in Alzheimer disease
- ICD10:
- F01 - Vascular dementia
- ICD10:
- F02 - Dementia in other diseases classified elsewhere
- ICD10:
- F03 - Unspecified dementia
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 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).
- Arm 2:
- Nurses will be also trained in symptom management (complex intervention no 2).
Endpoints
- 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.
- 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.
Study Design
- Purpose:
- Supportive care
- Allocation:
- Non-randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Crossover
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Switzerland
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Other Sunneziel Meggen Meggen, LU
- Other Alenia – Gepflegt Leben im Alter Gümligen, BE
- Other Bethesda Alterszentren AG Baden, AG
- Other GAG Genossenschaft für Altersbetreuung und Pflege Gäu Niederbuchsiten, SO
- Other AZW Alterszentrum Weinfelden Weinfelden, TG
- Other Seniorenzentrum Naters Naters, VS
- Other Alterszentrum Emmersberg Schaffhausen, SH
- Other neues marthastift Basel, BS
- Other Pflegehotel St. Johann Basel, BS
- Other Alterszentrum Bussnang Bussnang, TG
- Other Dhalia Oberaargau Wiedlisbach, BE
- Other Alters- und Pflegeheim Rosenberg Altdorf, UR
- Other Haus St. Theodul Fiesch, VS
- Other Haslibrunnen AG Langenthal, BE
- Other APH Hasle-Rüegsau Rüegsauschachen, BE
- Other Pflegeheim Sennhof Vordemwald, AG
- Other Haus der Generationen Steg, VS
- Other Lindenfeld Suhr, AG
- Other Tilia Köniz, BE
- Other Abendfrieden Kreuzlingen, TG
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2020-10-01
- Planned study completion date:
- 2023-12-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 260
- Final Sample Size:
- 257
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- 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)
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)
Addresses
Primary Sponsor
- Address:
- Heds FR, School of Health ProfessionsProfessor Andrea Luise KoppitzRoute des Arsenaux 16a1700 FreiburgSwitzerland
- Telephone:
- +41 26 429 60 44
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.heds-fr.ch/de/forschung/forschungsbereiche/altern/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Heds FR, School of Health ProfessionsProfessor Andrea Luise KoppitzRoute des Arsenaux 16a1700 FreiburgSwitzerland
- Telephone:
- +41 26 429 60 44
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.heds-fr.ch/de/forschung/forschungsbereiche/altern/
Contact for Public Queries
- Address:
- Heds FR, School of Health ProfessionsProfessor Andrea Luise KoppitzRoute des Arsenaux 16a1700 FreiburgSwitzerland
- Telephone:
- +41 26 429 60 44
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.heds-fr.ch/de/forschung/forschungsbereiche/altern/
Principal Investigator
- Address:
- Heds FR, School of Health ProfessionsProfessor Andrea Luise KoppitzRoute des Arsenaux 16a1700 FreiburgSwitzerland
- Telephone:
- +41 26 429 60 44
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.heds-fr.ch/de/forschung/forschungsbereiche/altern/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Schweizerische Akademie der Medizinischen WissenschaftenHaus der Akademien, Laupenstrasse 73001 BernSwitzerland
- Telephone:
- +41 311 306 92 70
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.samw.ch
Private sponsorship (foundations, study societies, etc.)
- Address:
- Gottfried und Julia Bangerter-Rhyner-StiftungLange Gasse 15, Postfach4002 BaselSwitzerland
- Telephone:
- +41 61 277 01 22
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bangerter-stiftung.ch/bangerter/de/stiftung/portrait.html
Ethics Committee
Address Ethics Committee
- Address:
- Kantonale Ethikkommission ZürichStampfenbachstrasse 1218090 ZürichSwitzerland
- Telephone:
- (+41)43-2597970
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.zh.ch/kek
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-09-20
- Ethics committee number:
- 2019-01847
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-06-04
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
- Other secondary IDs:
- SNCTP000003941 - SNTCP
- Other secondary IDs:
- 2019-01847 - BASEC-ID
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Dataset: Expected mid 2023, indexed and for download on https://zenodo.org/ (eventually embargoed, dependant on publisher)
Study protocol and other study documents
- Study protocols:
- Spichiger F, Koppitz AL, De Wolf-Linder S, Murtagh FEM, Volken T, Larkin P. Improving caring quality for people with dementia in nursing homes using IPOS-Dem: A stepped-wedge cluster randomized controlled trial protocol. J Adv Nurs. 2021 Oct;77(10):4234-4245. doi: 10.1111/jan.14953. Epub 2021 Jul 7. PMID: 34235765; PMCID: PMC8518061.
- Study abstract:
- Aims: We aim to evaluate the effectiveness of the Integrated Palliative Care Outcome Scale for people with dementia-based case studies to improve the caring quality for people with dementia in nursing homes by frontline staff and family members. Background: Swiss nursing homes mostly care for people with dementia. This population is at high risk of receiving little to no palliation for their complex needs. The majority of Swiss frontline healthcare staff do not systematically report on the needs of their residents. Additionally, family members do not routinely participate in assessment processes. Design: We will conduct a stepped-wedge cluster randomized trial of repeated assessment using the Integrated Palliative Care Outcome Scale for people with dementia (IPOS-Dem) and subsequent case studies. Clusters will consist of Swiss nursing homes randomly assigned to one of three sequential intervention time points. Methods: The study population will consist of people with dementia living in nursing homes with and without specialized dementia care facilities. Over 16 months, staff working at the frontline and family members will assess the needs and concerns of people with dementia using IPOS-Dem. Depending on sequence allocation, facilitated case studies will start after 3, 6 or 9 months. The primary outcome will be caring quality measured by QUALIDEM. The secondary outcome will be symptoms and concerns, as indicated by the IPOS-Dem sum-score. The Zürich Ethics Committee approved the study in 2019 (2019-01847). Impact: The results of this study will contribute to improving the effectiveness of person-centred care for people with dementia. Collaboration between healthcare staff and family members will be systematically developed and built upon thorough assessment using the IPOS-Dem and related case studies. The use of IPOS-Dem will offer all frontline staff a systematic approach to have an independent voice within the nursing process, regardless of their qualification or grade.
- Other study documents:
- Spichiger F, Keller Senn A, Volken T, Larkin P, Koppitz A. Integrated Palliative Outcome Scale for People with Dementia: easy language adaption and translation. J Patient Rep Outcomes. 2022 Feb 15;6(1):14. doi: 10.1186/s41687-022-00420-7. PMID: 35169943; PMCID: PMC8847462.
- Spichiger F, Volken T, Larkin P, Meichtry AA, Koppitz A. Inter-rating reliability of the Swiss easy-read integrated palliative care outcome scale for people with dementia. PLoS One. 2023 Aug 2;18(8):e0286557. doi: 10.1371/journal.pone.0286557. PMID: 37531385; PMCID: PMC10395940.
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry