Observing and recognizing symptoms and needs in people with dementia in care homes using a measurement instrument called IPOS-Dem
Zusammenfassung der Studie
We are conducting this project to reduce the symptom burden in people with dementia.
(BASEC)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Aarau, Basel, Bern, Luzern, St Gallen, Winterthur, Zürich
(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)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
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)
Allgemeine Auskünfte
Heds FR, School of Health Professions
+41 26 429 60 44
andrea.koppitz@clutterhefr.ch(ICTRP)
Wissenschaftliche Auskünfte
Heds FR, School of Health Professions
+41 26 429 60 44
andrea.koppitz@clutterhefr.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
04.06.2020
(BASEC)
ICTRP Studien-ID
DRKS00022339 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Burden of disease of people with dementia in nursing homes measured by IPOS-Dem: a stepped-wedge cluster randomized controlled trial (BASEC)
Wissenschaftlicher Titel
Burden of disease of people with dementia in nursing homes measured by IPOS-Dem: a stepped-wedge cluster randomised controlled trial - IPOS-Dem (ICTRP)
Öffentlicher Titel
Burden of disease of people with dementia in nursing homes measured by IPOS-Dem: a stepped-wedge cluster randomised controlled trial (ICTRP)
Untersuchte Krankheit(en)
Dementia, Alzheimer
F00
F01
F02
F03Dementia in Alzheimer diseaseVascular dementiaDementia in other diseases classified elsewhereUnspecified dementia (ICTRP)
Untersuchte Intervention
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)
Studientyp
interventional (ICTRP)
Studiendesign
Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: crossover; Study design purpose: supportive care (ICTRP)
Ein-/Ausschlusskriterien
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)
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
05.10.2020 (ICTRP)
Einschluss des ersten Teilnehmers
12.10.2020 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Andrea Luise Koppitz, andrea.koppitz@hefr.ch, +41 26 429 60 44, Heds FR, School of Health Professions (ICTRP)
Sekundäre IDs
U1111-1254-4246, SNCTP000003941, 2019-01847 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
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)
Weitere Informationen zur Studie
http://drks.de/search/en/trial/DRKS00022339 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
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 zu den Ergebnissen im Primärregister
nicht verfügbar