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Care4Youngdem: Care for people with Young-Onset Dementia towards the end of life/ Zorg bij dementie op jonge leeftijd


- candidate number25265
- NTR NumberNTR5989
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-sep-2016
- Secondary IDs839120003 ZonMw 
- Public TitleCare4Youngdem: Care for people with Young-Onset Dementia towards the end of life/ Zorg bij dementie op jonge leeftijd
- Scientific TitleEnd-of-life care in institutionalized people with Young-Onset Dementia (YOD): the Care4Youngdem study
- ACRONYMCare4Youngdem
- hypothesisThe aim of this study is to describe the last phase of life of people with young-onset dementia. The research questions for this prospective observational study are:
1. What is the practice of end of life care in people with young-onset dementia regarding advance care planning, symptom prevalence, pharmacological and non-pharmacological treatments, and spirituality?
2. What are the views of family members on end of life care regarding the process of shared decision making, social support, quality of life, quality of dying and satisfaction with care?
3. What are the views of elderly care physicians and nursing staff members of people with young-onset dementia on end of life care regarding the process of shared decision making, symptom management and quality of life?
4. What is the difference between the practice of end-of-life care and views in the terminal phase (last month of life) compared to the period prior to the terminal phase?
- Healt Condition(s) or Problem(s) studiedYoung-Onset Dementia
- Inclusion criteriaPatients are included when they:
(1) have a clinical diagnosis of dementia according to the diagnostic criteria with first symptom onset before the age of 65 years.
(2) provide informed (proxy) consent, and have a primary informal caregiver who is willing to participate in the questionnaire-based survey.
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2016
- planned closingdate1-jan-2021
- Target number of participants300
- InterventionsNot applicable
- Primary outcomeWe partly replicate our Dutch End-of-Life in Dementia (DEOLD) study, a large national cohort study on the course and care-related aspects of institutionalized people with late-onset dementia. Elderly care physicians and family members completed questionnaires covering a broad range of care-related aspects with a special emphasis on palliative care and end-of-life issues. In the DEOLD-study, patients were followed from the time of admission to the time of death or study conclusion, with semi-annual assessments/questionnaires in-between. In the current Care4Youngdem-study we will use a slightly different approach. For reason of feasibility we will only administer questionnaires at inclusion in the study (not necessarily upon admission) and after death of the patients. Furthermore, we will develop questionnaires for nursing staff members, in addition to the questionnaires for elderly care physicians and family-members, since they are important members of the health-care team.
We will address all long-term care facilities/organizations that have a specialized young-onset dementia care unit, and ask if they are willing to participate in the study. For feasibility and to reach adequate power for this study, all patients residing on this care unit, as well as patients who are newly admitted during the data collection period, are eligible for inclusion in the study.
The greater part of the DEOLD-questionnaires is appropriate for the use in the Care4Youngdem-study. This is important for reason of comparability. However, we carefully reviewed the questionnaires based on existing literature on YOD, methods used in, and results of, our NEEDYD and BEYOND-studies. We have slightly adapted the questionnaires where needed.
The questionnaires assess patient characteristics including type of dementia, comorbidity, Activities of Daily Living, and severity of dementia using the Bedford Alzheimer Nursing-Severity Scale (BANS-S) and the Global Deterioration Scale (GDS). Further, items on symptoms such as agitation, pain and shortness of breath, pharmacological treatments including use of opioids and non-pharmacological treatments such as the use of urinary catheters or tube feeding are included. The End-of-Life in Dementia (EOLD) subscales Symptom Management (EOLD-SM), Satisfaction With Care (EOLD-SWC) and Comfort Assessment in Dying (EOLD-CAD) the Quality of Life in Late-stage Dementia (QUALID), the short nursing home version of the Zarit Burden Interview (ZBI), the Quality of Dying in Long-Term Care (QOD-LTC) scale and the Social Support List (SSL) subscale emotional support with problems are also part of the questionnaires.
The most important primary outcomes are the EOLD subscales and the QUALID-scale. The original EOLD-SM consists of 9 symptoms such as fear, depression and resistiveness to care that are rated on a frequency-scale ranging from ‘never’ to ‘every day.’ The EOLD-SWC consists of 10 statements such as: “ I felt fully involved in all decision making” and “All measures were taken to keep my care recipient comfortable,” and the EOLD-CAD consists of 14 items such as crying, peace, and difficulty of swallowing which are rated on an intensity scale ranging from ‘a lot’ tot ‘not at all’. All scales have good internal consistency and reliability. In a recent study of our group, the EOLD-SWC and EOLD-CAD performed better than any other such instruments. The QUALID-scale is an 11-item scale that measures quality of life specifically in late-stage dementia. Finally, questions about advance care planning, advance directives and the process of shared decision-making are included in the questionnaires. Some items in the baseline questionnaire are similar to those in the after-death questionnaire, to allow for identifying change, for example, change in symptoms or quality of life. Further, a few items in the family questionnaire are the same as in the questionnaires for the elderly care physicians and nursing staff members, such as satisfaction with communication. However, most items are exclusive to physicians (e.g., medication), nursing staff members (e.g., symptoms) or families (e.g., satisfaction with care).
- Secondary outcomeNot applicable
- TimepointsWe will administer adapted versions of the Dutch End-of-life in Dementia(DEOLD)-questionnaires for the elderly care physicians, nursing staff members and the family-members of the people with young-onset dementia at inclusion. The single follow-up questionnaire for the elderly care physicians and nursing staff members will be administered two weeks after the patients’ death and the family-members will be asked to complete a single follow-up questionnaire two months after death of their relative.
- Trial web sitehttp://ukonnetwerk.nl/care4youngdem
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD Jenny T. van der Steen
- CONTACT for SCIENTIFIC QUERIESPhD Jenny T. van der Steen
- Sponsor/Initiator Radboud University Nijmegen Medical Centre, Department of Primary and Community Care (huispost 117)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Stichting Beroepsopleiding Huisartsen (SBOH)
- Publications
- Brief summaryYoung-onset dementia refers to the onset of dementia before the age of 65. Studies on characteristics of institutionalized people with young-onset dementia are largely lacking. Our Dutch Behavior and Evolution in Young-Onset Dementia (BEYOND)-study is the only study that assessed institutionalized people with young-onset dementia, but did not aim at mapping end-of-life care. As in people with late-onset dementia, people with young-onset dementia will die with or from dementia, but there are only few studies that report survival, mortality and cause of death in people with young-onset dementia. There are hardly any reports about palliative care practices, end-of-life decision-making or symptom prevalence and symptom management in people with young-onset dementia. However, it is likely that dying because of young-onset dementia has a different impact on the person with dementia and his relatives than in people with late-onset dementia, probably resulting in different needs and a different processes of decision-making. The white paper of the European Association for Palliative Care (EAPC) on defining palliative care in dementia that was published in 2014 was based on a Delphi study and limited to people with late-onset dementia. We propose a study in which we map the practice of end-of-life care in people with young-onset dementia from the views of elderly care physicians, nursing staff members, people with young-onset dementia and their family members and to provide young-onset dementia specific recommendations on palliative care. One of the objectives of this study is to identify the differences between end-of-life care in people with young-onset dementia compared to end-of-life care in people with late-onset dementia. To this end, the Care4Youngdem-study partly replicates The Dutch End-of-Life in Dementia (DEOLD)-study. The DEOLD study was a large national cohort-study on the course and care-related aspects of institutionalized people with late onset dementia. Elderly care physicians and family-members completed questionnaires covering a broad area of care-related aspects with special emphasis on palliative care.
The Care4Youngdem-study is a mixed-method study and consists of three parts, the first part concerns the prospective observational study which is further clarified in the sections mentioned above:
1. a. Questionnaire-based survey among nursing staff members and elderly care physicians who care for people with young-onset dementia on palliative care practices at baseline and within two weeks after death of institutionalized people with young-onset dementia.
b. Questionnaire based survey among family members on palliative care practices at baseline and within two months after death of institutionalized people with young onset dementia.
2. a. Focus group interviews with elderly care physicians and nursing staff members who care for institutionalized people with young-onset dementia.
b. Focus group interviews with community dwelling people with young-onset dementia and with family-members (partner, children, parents) about views regarding palliative care.
3. Delphi consensus procedure in order to formulate young-onset dementia specific recommendations for optimal palliative care to supplement the white paper based on the outcomes of part 1 and 2.
- Main changes (audit trail)
- RECORD8-sep-2016 - 16-sep-2016


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