DementiaDEMACTIFLASHNCT04094779
Effect of "breath of Fresh Air" Flash Activity on Dementia Agitation : Pilot Study
A study testing Usual relation care and Flash activity "breath of fresh air" in people with Dementia, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Non-drug therapies (NDT) constitute a strong axis of the person with dementia behaviour management. Among these NDT, the flash activities constitute a mode of intervention to prevent and control the expression of the most disruptive behavior. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Usual relation care and Flash activity "breath of fresh air"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2019to 8 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New patients admitted in the unit to the management of the Psychological and Behavioural Symptoms of Dementia
- Dementia regardless of etiology and severity
- Score greater than 2 than NPI established on entry into service
- Free, informed and written consent signed by the person trust and/or family member and/or legal representative
- Health insurance membership
Who cannot join
- Absence of agitation
- Juveniles
- Pregnant women
- Patient who has previously participated in the study
- Persons under protection of justice
Trial locations and contacts
1 site in 1 country.
About this study
Non-drug therapies (NDT) constitute a strong axis of the person with dementia behaviour management. Among these NDT, the flash activities constitute a mode of intervention to prevent and control the expression of the most disruptive behavior. These are short-term activities with the objective of decreasing the behavioural disorders intensity in less than 15 minutes.
The aim of this pilot study is to test the effect of a flash activity "breath of fresh air" compared to the usual relational care on the short-term decrease (15 min.) of the agitation in hospitalized dementia patients.
Read the detailed description
The "breath of fresh air" flash strategy is to offer the patient the possibility to go out of the medical unity and walking outdoor.
When the caregiver identify a level of agitation greater or equal to two on the gravity score and greater or equal to two on the impact score with the NPI test (The Neuropsychiatric Inventory Test), the caregiver let the patient wandering in the outside lanes of the hospital and encourage him to us his senses. For example, the sight could be stimulated by looking at a bird.
This variation of sensory stimulations enable a temporo-sensory break on the crisis, allowing the patient to turn his attention from the crisis context to another stimulation.
- Conditions
- Dementia
- Being tested
- Usual relation care, Flash activity "breath of fresh air"
- Keywords
- Agitation, Flash activity, Breath of fresh air
- Medical subject headings
- Dementia, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual relation careOther
When a patient begins to agitate, he will be isolated from the group to establish a dual relationship where the caregiver will try through his relational approach to calm the agitation.
Flash activity "breath of fresh air"Other
When a patient begins to agitate , he will be isolated from the group and the patient leave from the unit to walk outside with the caregiver.
| Study group | Role | What they receive |
|---|---|---|
| Usual relational care | Active comparator | Isolate the patient from the group of other patients in order to propose to him a a relationship dual with the caregiver to the aim to calm the agitation Receives: Other: Usual relation care |
| Flash activity "breath of fresh air" | Experimental | Isolate the patient from the group of other patients in order to propose to him in a relationship dual with the caregiver a physical activity outside the service that promotes relaxation by focusing his attention to the environment during 15 minutes Receives: Other: Usual relation care; Other: Flash activity "breath of fresh air" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the NeuroPsychiatric Inventory Reduced (NPI-reduced) score
Evolution of the score NPI-reduced agitation 15 minutes after installation of the strategy compared to the score assessed in the crisis. NPI reduced is about Gravity of the crisis from1 to 3 (1 better / 3 worse) and Impact of the crisis from 0 to 5 (0 better / 5 worse)
Measured: 15 minutes
Secondary outcomes (5)
Comparison of the NPI-reduced score
Evolution of the score NPI-reduced agitation 1 hours after installation of the strategy compared to the score assessed in the crisis. NPI reduced is about Gravity of the crisis from1 to 3 (1 better / 3 worse) and Impact of the crisis from 0 to 5 (0 better / 5 worse)
Measured: 1 hours
The Cohen-Mansfield Agitation Inventory (CMAI) score
Evaluation of the CMAI score to know the agitation level of the patient on the last 7 days with items about physical agitation and aggressivity, verbal agitation and aggressivity . From 0 to 203 (0 better / 203 worse)
Measured: 7 days
The Cohen-Mansfield Agitation Inventory (CMAI) score
Evaluation of the CMAI score to know the agitation level of the patient on the last 18 days with items about physical agitation and aggressivity, verbal agitation and aggressivity . From 0 to 203 (0 better / 203 worse)
Measured: 18 days
The NPI-CT (NeuroPsychiatric Inventory Care Team version) score
Evaluation oh the NPI-CT score to see the evolution of the overall intensity of behavioural disorders relative to the admission of patients. From 0 to 120 (0 better/ 120 worse)
Measured: 21 days
Number of therapeutic strategies used
Number of therapeutic strategies (anxiolytics, hypnotic, neuroleptic or physical restraint) received at the outcome of an episode of agitation for which the "Breath of fresh air" in the experimental arm or the helping relationship in the arm control would have been insufficient
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start20 Sep 2019
- Primary completion8 Mar 2022
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aneta BARTUSIAK, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094779
- Sponsor's protocol ID
- RC31/17/0348
- Acronym
- DEMACTIFLASH
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2019
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of "breath of Fresh Air" Flash Activity on Dementia Agitation : Pilot Study
- ClinicalTrials.gov ID
- NCT04094779
- Acronym / sponsor ID
- DEMACTIFLASH / RC31/17/0348
- Conditions
- Dementia
- Keywords
- Agitation, Flash activity, Breath of fresh air
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 19 Sep 2019 (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.
Non-drug therapies (NDT) constitute a strong axis of the person with dementia behaviour management. Among these NDT, the flash activities constitute a mode of intervention to prevent and control the expression of the most disruptive behavior. These are short-term activities with the objective of decreasing the behavioural disorders intensity in less than 15 minutes.
The aim of this pilot study is to test the effect of a flash activity "breath of fresh air" compared to the usual relational care on the short-term decrease (15 min.) of the agitation in hospitalized dementia patients.
Detailed description
The "breath of fresh air" flash strategy is to offer the patient the possibility to go out of the medical unity and walking outdoor.
When the caregiver identify a level of agitation greater or equal to two on the gravity score and greater or equal to two on the impact score with the NPI test (The Neuropsychiatric Inventory Test), the caregiver let the patient wandering in the outside lanes of the hospital and encourage him to us his senses. For example, the sight could be stimulated by looking at a bird.
This variation of sensory stimulations enable a temporo-sensory break on the crisis, allowing the patient to turn his attention from the crisis context to another stimulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual relational care | Active comparator | Other: Usual relation careIsolate the patient from the group of other patients in order to propose to him a a relationship dual with the caregiver to the aim to calm the agitation |
| Flash activity "breath of fresh air" | Experimental | Other: Usual relation care, Other: Flash activity "breath of fresh air"Isolate the patient from the group of other patients in order to propose to him in a relationship dual with the caregiver a physical activity outside the service that promotes relaxation by focusing his attention to the environment during 15 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- New patients admitted in the unit to the management of the Psychological and Behavioural Symptoms of Dementia
- Dementia regardless of etiology and severity
- Score greater than 2 than NPI established on entry into service
- Free, informed and written consent signed by the person trust and/or family member and/or legal representative
- Health insurance membership
Key exclusion criteria (5 listed)
- Absence of agitation
- Juveniles
- Pregnant women
- Patient who has previously participated in the study
- Persons under protection of justice
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 |
|---|---|---|
| Usual relation careWhen a patient begins to agitate, he will be isolated from the group to establish a dual relationship where the caregiver will try through his relational approach to calm the agitation. | Other | Flash activity "breath of fresh air", Usual relational care |
| Flash activity "breath of fresh air"When a patient begins to agitate , he will be isolated from the group and the patient leave from the unit to walk outside with the caregiver. | Other | Flash activity "breath of fresh air" |
Primary outcome
Comparison of the NeuroPsychiatric Inventory Reduced (NPI-reduced) score
Time frame: 15 minutes
Evolution of the score NPI-reduced agitation 15 minutes after installation of the strategy compared to the score assessed in the crisis. NPI reduced is about Gravity of the crisis from1 to 3 (1 better / 3 worse) and Impact of the crisis from 0 to 5 (0 better / 5 worse)
5 secondary outcomes
Comparison of the NPI-reduced score
Time frame: 1 hours
The Cohen-Mansfield Agitation Inventory (CMAI) score
Time frame: 7 days
The Cohen-Mansfield Agitation Inventory (CMAI) score
Time frame: 18 days
The NPI-CT (NeuroPsychiatric Inventory Care Team version) score
Time frame: 21 days
Number of therapeutic strategies used
Time frame: 18 days
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 25 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Aneta BARTUSIAK principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual relation care and Flash activity "breath of fresh air" in people with Dementia, run by University Hospital, Toulouse 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 5 inclusion and 5 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 25 Sep 2024. 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. 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?
Comparison of the NeuroPsychiatric Inventory Reduced (NPI-reduced) score (time frame: 15 minutes). 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 25 Sep 2024.