Gardens for people with dementia
| ISRCTN | ISRCTN14095773 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14095773 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | The Velux Foundations |
| Funder | Velux Fonden |
- Submission date
- 15/07/2022
- Registration date
- 28/07/2022
- Last edited
- 08/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
A limited amount of research has examined how nature-based palliative rehabilitation can be implemented in nursing homes for people with dementia, even though evidence suggests that these gardens are underused. The aim of the study is to develop and implement a nature-based palliative rehabilitation intervention on how nursing home gardens can be used by people with dementia to improve a range of health outcomes.
Who can participate?
People with dementia living in a long-term care nursing home and their care staff
What does the study involve?
An intervention where researchers, staff, residents and relatives co-design an activity program in a garden whereafter the program will be tested. The intervention involves staff using the garden together with residents twice a week for one month.
What are the possible benefits and risks of participating?
Possible benefits are improvements in well-being, better sleep and higher job satisfaction. Possible risks are that it may be time-consuming.
Where is the study run from?
The University of Southern Denmark (Denmark)
When is the study starting and how long is it expected to run for
January 2019 to September 2023
Who is funding the study
THE VELUX FOUNDATIONS (Velux Fonden) (Denmark)
Who is the main contact
Dr Tanja Schmidt (Denmark)
tbschmidt@health.sdu.dk
Contact information
Scientific
Campusvej 55
Odense
5230
Denmark
 ORCID ID |
0000-0003-2476-8711 |
|---|---|
| Phone | +45 61361525 |
| tbschmidt@health.sdu.dk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-cased quasi-experimental intervention study with no control group |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Nature-based palliative rehabilitation for people with dementia to lower behavioural and psychological symptoms of dementia |
| Study objectives | Rationale: we are assessing whether a nature-based palliative rehabilitation program in a nursing home for people with severe dementia, can positively affect residents' behavioural and psychological symptoms of dementia (BPSD), medication use, and care staff's burnout rate. |
| Ethics approval(s) |
Approved 26/11/2019, RIO (University of Southern Denmark ethics board) (Campusvej 55, Odense M, 5230, Denmark; +45 65507550; sdu.persondata@sdu.dk), ref: 10.804 |
| Health condition(s) or problem(s) studied | Lowering behavioural and psychological symptoms of dementia (BPSD) symptoms and medication in people with severe dementia |
| Intervention | We will create a nature-based palliative rehabilitation program together with a nursing home for people with dementia. This includes re-designing their garden to accommodate activities for people with dementia. Staff are required to use the garden together with residents 2 times a week for a whole month. We will collect baseline and follow-up data on behavioural and psychological symptoms of dementia (BPSD) symptoms using the Neuropsychiatric Inventory Nursing Home Version (NPI-NH) survey, registration of medication use, and a survey on staff burnout. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Behavioural and psychological symptoms of dementia (BPSD) measured using the Neuropsychiatric Inventory Nursing Home Version (NPI-NH) survey at baseline and 1 month after |
| Key secondary outcome measure(s) |
1. Staff burnout measured using a questionnaire administered to staff at baseline and 1 year after |
| Completion date | 29/09/2023 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 138 |
| Key inclusion criteria | 1. People with dementia living at a long-term care nursing home in Denmark 2. Staff caring for people with dementia living at a long-term care nursing home in Denmark |
| Key exclusion criteria | Staff who do not have care responsibilities |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 01/06/2022 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Haderslev
6100
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Current IPD sharing plan as of 08/05/2025: The data generated and/or analyzed during this study may be made available from the main contact person, Thomas Skovgaard (tskovgaard@health.sdu.dk), starting 01/01/2025, for a period of one year. Access may be granted upon reasonable request to researchers affiliated with recognized research institutions, for research purposes only. Data will be fully anonymized, and appropriate consent will be obtained prior to any sharing. Previous IPD sharing plan: The datasets generated during and analysed during the current study will be available upon request from Tanja Schmidt, tbschmidt@health.sdu.dk, anonymized data, 01/01/2025, for 1 year, by other researchers working at research institutes, for research purposes only, consent will be obtained, and data anonymized. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 23/10/2022 | 25/10/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/05/2025: The individual participant data (IPD) sharing plan and publication and dissemination plan were updated.
31/10/2024: The intention to publish date was changed from 01/12/2024 to 01/07/2025.
11/08/2023: The following changes have been made:
1. Care home was added as a study setting and Other was removed.
2. The overall study end date has been changed from 31/08/2023 to 29/09/2023 and the plain English summary was updated accordingly.
25/10/2022: Publication reference added.
29/07/2022: Trial's existence confirmed by sponsor Velux Fonden, which is funding the study.
