Alzheimer DiseaseNCT04903171
Effects of Enriched Gardens in Nursing Home Residents With Dementia
A study testing INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN in people with Alzheimer Disease, run by RIVAGES at 1 site in France.
Trial summary
Comparing the effect of the frequentation of an enriched garden vs sensory conventional garden by nursing home residents with Alzheimer disease. The effects will be evaluated as regards to cognitive impairment (MMSE), autonomy (ADL) and prevention of falls (Unipodal stance and UpandGo Test) Read more about this study
- Who is it for?
- Ages 75 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2020to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Give consent
- Ability walking alone
- Alzheimer's disease
Who cannot join
- No dementia
- Severe dementia
- Severe behavioural disorder
- Inability to walk alone
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université
Ivry-sur-Seine, Val De Marne, 94200
About this study
Official title: Effects of Enriched Gardens on Cognition and Independence of Nursing Home Residents With Dementia: a Cluster-controlled Trial
Comparing the effect of the frequentation of an enriched garden vs sensory conventional garden by nursing home residents with Alzheimer disease. The effects will be evaluated as regards to cognitive impairment (MMSE), autonomy (ADL) and prevention of falls (Unipodal stance and UpandGo Test)
Read the detailed description
The cluster controlled trial is conducted over a six months period after recruitment of residents from 4 different nursing homes in France. The participants are distributed into 3 groups. One group does not receive incentive from carers to visit any garden, the second group receives incentives to visit regularly a conventional sensory garden and the third group receive incentives from carers to visit regularly an enriched garden. The study is conducted over a period of 6 months. All participants are giving consent to the study. They will be evaluated before and after over 4 different tests. MMSE (Mini Mental Status Examination) for cognitive impairment, ADL (Activity for day Living) for functional autonomy, TUG (Test up and Go) and Unipodal Stance for prevention of falls.
- Conditions
- Alzheimer Disease
- Being tested
- INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN
- Keywords
- Alzheimer, Enriched garden, Enriched environment, Dementia, Cognitive impairment, Functional autonomy
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDENOther
Carers invites every the participants of group 2 and 3 visiting their respective gardens (enriched or conventional sensory garden)
| Study group | Role | What they receive |
|---|---|---|
| GROUP ONE | No intervention | The participants do not receive incentive to visit any gardens |
| GROUP TWO | Placebo comparator | The participants receive incentives by carers to visit regularly a conventional sensory garden Receives: Other: INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN |
| GROUP THREE | Experimental | The participants receive incentives by carers to visit regularly an enriched garden Receives: Other: INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global cognitive function
Mini Mental Status Examination (MMSE) , 0-30, higher score is the better outcome
Measured: 6 MONTHS
Change in functional independence
Activities of daily living (ADL), 0-6, higher score is the better outcome
Measured: 6 MONTHS
Secondary outcomes (2)
Change in gait ability
Timed Up and Go test (sec), higher time is the worse outcome
Measured: 6 MONTHS
Change in balance
Unipodal Stance (sec), higher time is the better outcome
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start15 Mar 2020
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cluster controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- RIVAGES
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903171
- Sponsor's protocol ID
- RIVAGES
- Status last verified
- May 2021
- First submitted
- 3 Mar 2021
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be available to study reviewers
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Enriched Gardens on Cognition and Independence of Nursing Home Residents With Dementia: a Cluster-controlled Trial
- ClinicalTrials.gov ID
- NCT04903171
- Acronym / sponsor ID
- RIVAGES
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer, Enriched garden, Enriched environment, Dementia, Cognitive impairment, Functional autonomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- RIVAGESUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing the effect of the frequentation of an enriched garden vs sensory conventional garden by nursing home residents with Alzheimer disease. The effects will be evaluated as regards to cognitive impairment (MMSE), autonomy (ADL) and prevention of falls (Unipodal stance and UpandGo Test)
Detailed description
The cluster controlled trial is conducted over a six months period after recruitment of residents from 4 different nursing homes in France. The participants are distributed into 3 groups. One group does not receive incentive from carers to visit any garden, the second group receives incentives to visit regularly a conventional sensory garden and the third group receive incentives from carers to visit regularly an enriched garden. The study is conducted over a period of 6 months. All participants are giving consent to the study. They will be evaluated before and after over 4 different tests. MMSE (Mini Mental Status Examination) for cognitive impairment, ADL (Activity for day Living) for functional autonomy, TUG (Test up and Go) and Unipodal Stance for prevention of falls.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Cluster controlled trial
| Arm | Type | Receives |
|---|---|---|
| GROUP ONE | No intervention | –The participants do not receive incentive to visit any gardens |
| GROUP TWO | Placebo comparator | Other: INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDENThe participants receive incentives by carers to visit regularly a conventional sensory garden |
| GROUP THREE | Experimental | Other: INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDENThe participants receive incentives by carers to visit regularly an enriched garden |
Who may qualify
- Ages
- 75 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Give consent
- Ability walking alone
- Alzheimer's disease
Key exclusion criteria (4 listed)
- No dementia
- Severe dementia
- Severe behavioural disorder
- Inability to walk alone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDENCarers invites every the participants of group 2 and 3 visiting their respective gardens (enriched or conventional sensory garden) | Other | GROUP THREE, GROUP TWO |
Primary outcome
Change in global cognitive function
Time frame: 6 MONTHS
Mini Mental Status Examination (MMSE) , 0-30, higher score is the better outcome
Change in functional independence
Time frame: 6 MONTHS
Activities of daily living (ADL), 0-6, higher score is the better outcome
2 secondary outcomes
Change in gait ability
Time frame: 6 MONTHS
Change in balance
Time frame: 6 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Individual participant dataSharing planned: No. IPD will only be available to study reviewers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN in people with Alzheimer Disease, run by RIVAGES at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global cognitive function (time frame: 6 MONTHS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.