ISRCTN ISRCTN14095773
DOI https://doi.org/10.1186/ISRCTN14095773
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Tanja Schmidt
Scientific

Campusvej 55
Odense
5230
Denmark

ORCiD logoORCID ID 0000-0003-2476-8711
Phone +45 61361525
Email tbschmidt@health.sdu.dk

Study information

Study designSingle-cased quasi-experimental intervention study with no control group
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Care home
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleNature-based palliative rehabilitation for people with dementia to lower behavioural and psychological symptoms of dementia
Study objectivesRationale: 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) studiedLowering behavioural and psychological symptoms of dementia (BPSD) symptoms and medication in people with severe dementia
InterventionWe 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 typeBehavioural
Primary outcome measureBehavioural and psychological symptoms of dementia (BPSD) measured using the Neuropsychiatric Inventory Nursing Home Version (NPI-NH) survey at baseline and 1 month after
Secondary outcome measures1. Staff burnout measured using a questionnaire administered to staff at baseline and 1 year after
2. Medication measured using staff registrations at baseline and 1 month after
Overall study start date01/01/2019
Completion date29/09/2023

Eligibility

Participant type(s)Patient, Health professional
Age groupAdult
SexBoth
Target number of participants52 people with dementia and 86 care staff
Key inclusion criteria1. 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 criteriaStaff who do not have care responsibilities
Date of first enrolment01/06/2022
Date of final enrolment01/06/2022

Locations

Countries of recruitment

  • Denmark

Study participating centre

Kildebakken Plejecenter
Varbergvej 13
Haderslev
6100
Denmark

Sponsor information

The Velux Foundations
Charity

Tobaksvejen 10
Søborg
2860
Denmark

Phone +45 39 57 09 57
Email info@VELUXFOUNDATIONS.dk
Website https://veluxfoundations.dk
ROR logo "ROR" https://ror.org/007ww2d15

Funders

Funder type

Charity

Velux Fonden
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Velux Foundations, The Velux Foundations
Location
Denmark

Results and Publications

Intention to publish date01/07/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planCurrent publication and dissemination plan as of 08/05/2025:
1. Planned publication in peer-reviewed journals
2. Participation in two international conferences
3. Develop a practical guide (The Dementia-Friendly Garden) for further dissemination




Previous publication and dissemination plan:
1. Planned publication in a high-impact peer-reviewed journal
2. Participation in two international conferences
IPD sharing planCurrent 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

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.