Observing and recognizing symptoms and needs in people with dementia in care homes using a measurement instrument called IPOS-Dem
Summary description of the study
We are conducting this project to reduce the symptom burden in people with dementia.
(BASEC)
Intervention under investigation
The observations of caregivers and family members of people with dementia are systematically documented using the measurement instrument IPOS-Dem (=Intervention 1). Then (= Intervention 2), in a case discussion, it is decided which nursing measures can be initiated to reduce the burdens caused by disease symptoms in the person with dementia.
(BASEC)
Disease under investigation
The project first investigates the validity of the measurement instrument IPOS-Dem. Secondly, it examines to what extent the symptom burden and the severity of symptom expression in people with dementia can be altered by applying the IPOS-Dem. In this evaluation, caregivers and family members are supported by an experienced healthcare professional when applying the IPOS-Dem.
(BASEC)
1. Care homes: must care for at least 8 residents with dementia and must work with a documentation system called BESA or RAI. 2. Residents with dementia: Must either have the medical diagnosis of Alzheimer’s or vascular dementia, or symptoms of dementia must be documented in the documentation system. 3. Caregivers: Must be at least 18 years old, employed in the selected care home for at least 3 months, must be proficient in the German language, and must work at least one day a week in the selected care home. 4. Family members: The person with dementia must have a family member or a guardian. (BASEC)
Exclusion criteria
1. Residents with dementia: Are in the hospital or another medical facility at the start of the study. 2. Caregivers: cannot communicate in German. (BASEC)
Trial sites
Aarau, Basel, Bern, Luzern, St. Gallen, Winterthur, Zurich
(BASEC)
Sponsor
HES-SO Fribourg University of Applied Sciences and Arts of Western Switzerland Institute of Applied Health Research School of Health Sciences Fribourg (HedS-FR)
(BASEC)
Contact
Contact Person Switzerland
Andrea L. Koppitz
+41 26 429 60 44
andrea.koppitz@clutterhefr.chHES-SO Fribourg University of Applied Sciences and Arts of Western Switzerland Institute of Applied Health Research School of Health Sciences Fribourg (HedS-FR) Route des Arsenaux 16a ▪ 1700 Fribourg ▪ Switzerland
(BASEC)
General Information
Heds FR, School of Health Professions
+41 26 429 60 44
andrea.koppitz@clutterhefr.ch(ICTRP)
Scientific Information
Heds FR, School of Health Professions
+41 26 429 60 44
andrea.koppitz@clutterhefr.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
04.06.2020
(BASEC)
ICTRP Trial ID
DRKS00022339 (ICTRP)
Official title (approved by ethics committee)
Burden of disease of people with dementia in nursing homes measured by IPOS-Dem: a stepped-wedge cluster randomized controlled trial (BASEC)
Academic title
Burden of disease of people with dementia in nursing homes measured by IPOS-Dem: a stepped-wedge cluster randomised controlled trial - IPOS-Dem (ICTRP)
Public title
Burden of disease of people with dementia in nursing homes measured by IPOS-Dem: a stepped-wedge cluster randomised controlled trial (ICTRP)
Disease under investigation
Dementia, Alzheimer
F00
F01
F02
F03Dementia in Alzheimer diseaseVascular dementiaDementia in other diseases classified elsewhereUnspecified dementia (ICTRP)
Intervention under investigation
Group 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 (active intervention component 1).
Group 2: Nurses will be also trained in symptom management (active intervention component 2). (ICTRP)
Type of trial
interventional (ICTRP)
Trial design
Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: crossover; Study design purpose: supportive care (ICTRP)
Inclusion/Exclusion criteria
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) (ICTRP)
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)
Primary and secondary end points
The improvement (= significant improvement of p<0.05) of Quality of life in People with Dementia (PwD) measured with the QUALIDEM outcome measure.
QUALIDEM is a proxy-rated, 18 item assessment instrument completed by frontline staff in nursing homes. The version used in this study assesses quality of life in people with moderate advanced dementia with regard to six dimensions and a total score.
The QUALIDEM will be measured every three months for 15 months. Longitudinal, total domain scores for People with Dementia will be calculated and illustrated to demonstrate the quality of life trajectory. The primary endpoint will be assessed between baseline, and month 1-15.
(ICTRP)
The secondary endpoint of this study is Burden of disease (BOD):
A reduction of burden of disease (BOD), measured with the total IPOS-Dem score (sum-score) in PwD compared to before and after the interventions. (ICTRP)
Registration date
05.10.2020 (ICTRP)
Incorporation of the first participant
12.10.2020 (ICTRP)
Secondary sponsors
not available
Additional contacts
Andrea Luise Koppitz, andrea.koppitz@hefr.ch, +41 26 429 60 44, Heds FR, School of Health Professions (ICTRP)
Secondary trial IDs
U1111-1254-4246, SNCTP000003941, 2019-01847 (ICTRP)
Results-Individual Participant Data (IPD)
YesSpichiger, F., & Koppitz, A. (2024). Intervention effect of person profiles for people with advanced dementia: Stepped-wedge cluster randomised trial [Data set]. Zenodo. https://doi.org/10.5281/zenodo.4008427 Frank Spichiger, & Andrea Koppitz. (2023). Inter-rating reliability of the Swiss Easy-Read Integrated Palliative Care Outcome Scale for People with Dementia [Data set]. Zenodo. https://doi.org/10.5281/zenodo.8036812 Frank Spichiger, & Andrea L. Koppitz. (2023). Recruitment material and templates for the IPOS-Dem trial. Zenodo. https://doi.org/10.5281/zenodo.7840060 (ICTRP)
Further information on the trial
http://drks.de/search/en/trial/DRKS00022339 (ICTRP)
Results of the trial
Results summary
We recruited 240 people with dementia from 23 long-term care facilities. Modeling 1143 observations, we found a statistically significant positive intervention effect of 2.6 points according to the QUALIDEM (95% CI, 1.34�3.86; P < .001; total QUALIDEM intervention: 67; 95% CI, 64.8�69.1 vs 64.4; 95% CI, 62.3�66.4 for the control). We also found positive effects of the intervention on all secondary outcomes. (ICTRP)
Link to the results in the primary register
not available