SENIORS-D: Person-centred care for people with dementia
| ISRCTN | ISRCTN18012991 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18012991 |
| Secondary identifying numbers | BASEC-Nr. 2020-01872 |
- Submission date
- 03/02/2021
- Registration date
- 12/02/2021
- Last edited
- 27/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Dementia is a general term for loss of memory, language, problem-solving and other thinking abilities that are severe enough to interfere with daily life. Alzheimer's is the most common cause of dementia.
People suffering from dementia (PwD) are often no longer able to express symptoms such as pain due to their illness. In order for these to be recognised and treated, a systematic recording and assessment of these distressing symptoms using a reliable instrument is required. The IPOS-Dem is a robust, high-quality, easy-to-use measurement instrument that was developed in England with the involvement of carers and relatives for the assessment of these distressing symptoms. There is currently no comparable instrument available in Switzerland. For use in Switzerland, the IPOS-Dem was translated and adapted to the Swiss cultural context. In a next step, the validity of the translated IPOS-Dem version will be evaluated in both the acute setting and community care setting in the German-speaking part of Switzerland.
Who can participate?
- Every person with dementia (diagnosed or verified by health care professionals).
- Relatives of the person with dementia, who are directly involved in the care.
- Nurses of any grade, who are directly involved in the care of the person with dementia.
What does the study involve?
Nurses and relatives are asked to complete the IPOS-Dem and additional assessment instruments at two time points. The time required to complete the documents varies between 10 and 30minutes.
What are the possible benefits and risks of participating?
PwD: Immediate overview about most critical symptoms to be addressed.
Relatives: Immediate overview about most critical symptoms to be addressed.
Nurses: Ability to assess symptom burden and -severity systematically and within a short period of time.
Relatives: potential emotional response due to the scale of the symptom burden and -severity and consequent impact on PwD.
Nurses: potential emotional response due to the scale of the symptom burden and -severity and consequent impact on PwD.
Where is the study run from?
This study is run from 21 (updated 01/04/2022, previously: ten) different sites (acute care ward (hospital) and district nurse services) in the German-speaking part of Switzerland.
When is the study starting and how long is it expected to run for?
July 2020 to February 2023
Who is funding the study?
This project is funded from the Gloria Grathwohl-Palliative-Foundation: https://www.gloria-grathwohl-palliativ-stiftung.ch/ (Switzerland)
Who is the main contact?
Professor Dr Maria Schubert, maria.schubert@zhaw.ch
Contact information
Scientific
Katharina Sulzer Platz 9
CH-8400 Winterthur
Winterthur
8400
Switzerland
 ORCID ID |
0000-0002-0382-9290 |
|---|---|
| Phone | + 41 (0)58 934 6503 |
| maria.schubert@zhaw.ch |
Public
Katharina-Sulzer Platz 9
CH-8400 Winterthur
Winterthur
8400
Switzerland
| ORCID ID |
0000-0003-3421-2418 |
|---|---|
| Phone | +41796658051 |
| susanne.dewolf-linder@zhaw.ch |
Study information
| Study design | Multicenter non-randomized quasi-experimental repeated measures intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | SENIORS-D Project: PerSon-cENtred care for people with dementIa: Outcome guided palliative caRe through impeccable recognition of relevant Symptoms, neeDs, and care issues. |
| Study acronym | SENIORS-D |
| Study objectives | For this full psychometric validation, objectives are defined, which are of similar rank and follow a linear alignment and cannot be divided in primary and secondary objective: To assess the validity and reliability of the Swiss-German IPOS-Dem To assess interpretability of the Swiss-German IPOS Dem To assess responsiveness to change of the Swiss-German IPOS Dem To evaluate the construct validity of the IPOS-DEM with reference to the internal structure, convergent and discriminant validity |
| Ethics approval(s) | Approved 08/04/2021, Cantonal Ethics Committee Zurich (Stampfenbachstrasse 121, P8090 Zürich, Switzerland; +41 43 259 79 70; admin.kek@kek.zh.ch), ref: 2020-01872 |
| Health condition(s) or problem(s) studied | Recognition of burdensome symptoms and needs in people with dementia |
| Intervention | The nature of the intervention is the nurse’s or relative’s estimation and documentation of possible symptoms, which affect the PwD. The IPOS-Dem (instrument to be validated) is guiding the nurses’ and relatives’ estimation and documentation. In order to evaluate the psychometric properties of the IPOS-Dem, the intervention will be conducted at one time point (validity) and two time points (reliability, responsiveness to change, and interpretability) by the corresponding participants, who are looking after PwD. The exact same intervention will be conducted for each PwD included into the study. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 01/04/2022: Burden of physical-, psychological, social-, and spiritual symptoms measured with the Integrated Palliative Care Outcome Scale for People with Dementia (IPOS-Dem), the German version of the Edmonton Symptom Assessment System (revised version) (ESAS-r), and the Nursing Diagnosis according to the NANDA-I Taxonomy. Measured at two-time points with a minimum of three days in between, i.e. at baseline and when the PwDs health status changes or at day 45, whichever comes first Previous primary outcome measure: Burden of physical-, psychological, social-, and spiritual symptoms measured with the Integrated Palliative Care Outcome Scale for People with Dementia (IPOS-Dem), the German version of the Edmonton Symptom Assessment Scale (MIDOS2), and the Nursing Diagnosis according to the NANDA-I Taxonomy. Measured at two-time points with a minimum of three days in between, i.e. at baseline and when the PwDs health status changes or at day 45, whichever comes first |
| Secondary outcome measures | Current secondary outcome measures as of 01/04/2022: Measured at baseline and when the PwDs health status changes or at day 45, whichever comes first: 1. Functional Status measured with the German Version of the Edmonton Symptom Assessment System (revised version) (ESAS-r) 2. Quality of life in Dementia measured with the QUALIDEM 3. Australian Karnofsky Performance Scale (AKPS) 4. Global Rating of Change (GRC) Previous secondary outcome measures: Measured at baseline and when the PwDs health status changes or at day 45, whichever comes first: 1. Functional Status measured with the German Version of the Edmonton Symptom Assessment Scale (MIDOS2) 2. Quality of life in Dementia measured with the QUALIDEM |
| Overall study start date | 01/07/2020 |
| Completion date | 28/02/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 370 |
| Total final enrolment | 193 |
| Key inclusion criteria | PwD (patients at home and/or on the acute geriatric ward): 1. PwD with a diagnosis of vascular dementia or Alzheimer disease, which is documented in the patient notes, or 2. PwD with dementia-like symptoms (cognitive impairment measured with the MMSE< 24, and people who are unable to self-report due to cognitive impairment will be included in this study 3. PwD, who have a next of kin or a legal guardian Nurses and relatives (relatives at home and/or acute geriatric ward and district nurses or ward nurses): 1. Nursing staff and relatives must be at least 18 years of age. Nursing staff must have been employed at least six months 2. Nursing staff and relatives must be able to communicate (speak and understand) in German 3. Relatives, who care for a family member or close friend who is diagnosed with vascular dementia or Alzheimer disease or who presents with dementia-like symptoms |
| Key exclusion criteria | PwD (patients at home and/or on acute geriatric ward): 1. PwD, who are dying when admitted to hospital 2. PwD, who have no next of kin and no legal guardian Nurses and relatives (relatives at home and/or acute geriatric ward and district nurses or ward nurses): 1. Member of nursing staff or relatives younger than 18 years 2. Relative who is not involved in the daily care of PwD |
| Date of first enrolment | 01/04/2021 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Switzerland
Sponsor information
University/education
Gertrudstrasse 15
Winterthur
8401
Switzerland
| Phone | +41 589347171 |
|---|---|
| info@zhaw.ch | |
| Website | https://www.zhaw.ch/en/university/ |
"ROR" |
https://ror.org/05pmsvm27 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 21/12/2024 | 27/01/2025 | Yes | No |
Editorial Notes
27/01/2025: Publication reference added.
17/09/2024: The intention to publish date was changed from 30/09/2024 to 01/01/2025.
25/06/2024: The following changes were made:
1. The total final enrolment was changed from 155 to 193.
2. The intention to publish date was changed from 31/12/2023 to 30/09/2024.
09/01/2023: Total final enrolment was added.
29/12/2022: The overall trial end date has been changed from 18/02/2023 to 28/02/2023.
28/12/2022: The following changes have been made:
1. The overall trial end date has been changed from 31/12/2022 to 18/02/2023 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 31/03/2023 to 31/12/2023.
01/04/2022: The following changes have been made:
1. The primary outcome measure has been updated.
2. The secondary outcome measures have been updated.
3. The trial website link has been changed.
4. The plain English summary has been updated.
31/03/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2022 to 31/12/2022.
2. The overall trial end date has been changed from 31/03/2022 to 31/12/2022 and the plain English summary has been updated to reflect this change.
3. The trial website has been added.
21/04/2021: The ethics approval has been added.
15/03/2021: The recruitment start date has been changed from 01/03/2021 to 01/04/2021.
12/02/2021: Trial’s existence confirmed by Cantonal Ethics-committee Zurich.
