DementiaNCT02403245
Social Interactions Between People With Dementia in Nursing Home
A study testing Psychosocial stimulation in people with Dementia and Social Interactions, run by Paris West University Nanterre La Défense.
Trial summary
The aim of this study is to evaluate the direct impact of one session of social stimulation on social interactions of people with moderate dementia living in nursing home in comparison of one session without direct social stimulation. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Dementia, Social Interactions
- What is being tested?
- Psychosocial stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Feb 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- presence of a diagnostic of dementia in medical report and a MMSE score between 9 and 20.
Who cannot join
- arrival in the institution dating less than six months
- invalidating visual or hearing disorders
- phasic disorders not allowing a minimum of communication
- significant behavioural disorders (which can disturb the meeting)
- residents not fluent in French language
About this study
Official title: The Impact of a Social Stimulation on Social Interactions in Institutionalized People With Dementia
The aim of this study is to evaluate the direct impact of one session of social stimulation on social interactions of people with moderate dementia living in nursing home in comparison of one session without direct social stimulation.
Read the detailed description
60 people with moderate dementia living in a french nursing homme participated in this study. Residents gave oral consent twice to participate. They were classified in groups of six residents taking into account socio-demographic and medical characteristics. Two experimental conditions were proposed : 1. a social stimulation session (36 residents) and 2. a control group without direct social stimulation (24 residents). Collected socio-demographic and medical characteristics are age, gender, timf of institutionalization, sociocultural level, marital status and diagnostic hypothesis. Before the study, scales and questionnaires were used to assess cognitive status with the Mini Mental State Examination (Folstein et al, 1975); functional abilities with Instrumental Activities of Daily Living (Lawton and Brody, 1969); depression with the Cornell Scale for Depression in Dementia (Alexopoulos et al, 1988); psychological and behavioural disorders with the Neuropsychiatric Inventory (Cummings et al, 1994); and the quality of life with the Alzheimer's Disease Related Quality of Life (Rabins et al, 1999).
Social interactions are video taped and analyzed in a grid of observation.
The aim of the study is to see if there is an impact on social interactions after just one social stimulation session compared to a control group situation. Expected results are that residents of the social stimulation group will have more social interactions between us than the resident of the control group.
- Conditions
- Dementia, Social Interactions
- Being tested
- Psychosocial stimulation
- Keywords
- Social interactions, Dementia, Social stimulation, Direct observation
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial stimulationOther
Intervention consists in a session of social stimulation during about 40 minutes through where the speaker introduced himself to the residents and introduces the residents to each others. The date of the day was done to residents. Social stimulation consists here to an exercise about the four seasons. Residents are asked to mention the 4 seasons and to give all the characteristics they can about each season. Two exercises were proposed: 4 pictures of landscapes and residents were asked to tell which season is represent on the pictures and pictures of some fruits and residents tried to tell in which season we find the fruits. Finally, the psychologist speaks about the "four season" of the compositor Vivaldi and propose to the residents to listen some extracts of each pieces of music.
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial stimulation | Experimental | One session of a social stimulation Receives: Other: Psychosocial stimulation |
| Control group | No intervention | Residents are in a social controlled condition but without direct stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed social behaviours
social behaviours of residents observed and listed in an observations grid to analyze the results from observation in terms of components of behaviours expressed in means of observed behaviours.
Measured: during 8 minutes before the session a
Observed social behaviours
social behaviours of residents observed and listed in an observations grid to analyze the results from observation in terms of components of behaviours expressed in means of observed behaviours.
Measured: during 8 minutes after the session
Secondary outcomes (5)
Cognitive Status
Scale of the Mini Mental State of examination scored on 30 points.
Measured: Baseline
Functional abilities
Scale of the Instrumental Activities of Daily Living scored on 14 points. More the score is high more the people is independent in daily living.
Measured: Baseline
Depression
Cornell Scale for Depression in Dementia scored on 38 points. More the score os high more the people is depressed with a threshold score of 10.
Measured: Baseline
Psychological and behaviors disorders
Neuropsychiatric Inventory : hetero-evaluation of the psychological and behavioural disorders in 12 domains with the frequency of occurrence of the disorder, the intensity and the resounding on caregivers.
Measured: Baseline
Quality of life
Hetero-evaluation scale named Alzheimer's Disease Related Quality of life expressed in percentage. A high score means a good quality of life.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2012
- Primary completionJan 2015
- Study completionFeb 2015
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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paris West University Nanterre La Défense
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Principal investigator, Jean-Bernard Mabire, Paris West University Nanterre La Défense
- Investigators
- Jean-Bernard Mabire, Principal investigator, University Paris Ouest - EA 4430 - 200, Avenue de la République - 92001 Nanterre cedex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403245
- Sponsor's protocol ID
- SID010
- Status last verified
- Mar 2015
- First submitted
- 16 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Social Stimulation on Social Interactions in Institutionalized People With Dementia
- ClinicalTrials.gov ID
- NCT02403245
- Acronym / sponsor ID
- SID010
- Conditions
- Dementia, Social Interactions
- Keywords
- Social interactions, Dementia, Social stimulation, Direct observation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Paris West University Nanterre La DéfenseUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- Mar 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 31 Mar 2015 (estimated)
- 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.
The aim of this study is to evaluate the direct impact of one session of social stimulation on social interactions of people with moderate dementia living in nursing home in comparison of one session without direct social stimulation.
Detailed description
60 people with moderate dementia living in a french nursing homme participated in this study. Residents gave oral consent twice to participate. They were classified in groups of six residents taking into account socio-demographic and medical characteristics. Two experimental conditions were proposed : 1. a social stimulation session (36 residents) and 2. a control group without direct social stimulation (24 residents). Collected socio-demographic and medical characteristics are age, gender, timf of institutionalization, sociocultural level, marital status and diagnostic hypothesis. Before the study, scales and questionnaires were used to assess cognitive status with the Mini Mental State Examination (Folstein et al, 1975); functional abilities with Instrumental Activities of Daily Living (Lawton and Brody, 1969); depression with the Cornell Scale for Depression in Dementia (Alexopoulos et al, 1988); psychological and behavioural disorders with the Neuropsychiatric Inventory (Cummings et al, 1994); and the quality of life with the Alzheimer's Disease Related Quality of Life (Rabins et al, 1999).
Social interactions are video taped and analyzed in a grid of observation.
The aim of the study is to see if there is an impact on social interactions after just one social stimulation session compared to a control group situation. Expected results are that residents of the social stimulation group will have more social interactions between us than the resident of the control group.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial stimulation | Experimental | Other: Psychosocial stimulationOne session of a social stimulation |
| Control group | No intervention | –Residents are in a social controlled condition but without direct stimulation. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- presence of a diagnostic of dementia in medical report and a MMSE score between 9 and 20.
Key exclusion criteria (5 listed)
- arrival in the institution dating less than six months
- invalidating visual or hearing disorders
- phasic disorders not allowing a minimum of communication
- significant behavioural disorders (which can disturb the meeting)
- residents not fluent in French language
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 |
|---|---|---|
| Psychosocial stimulationIntervention consists in a session of social stimulation during about 40 minutes through where the speaker introduced himself to the residents and introduces the residents to each others. The date of the day was done to residents. Social stimulation consists here to an exercise about the four seasons. Residents are asked to mention the 4 seasons and to give all the characteristics they can about each season. Two exercises were proposed: 4 pictures of landscapes and residents were asked to tell which season is represent on the pictures and pictures of some fruits and residents tried to tell in which season we find the fruits. Finally, the psychologist speaks about the "four season" of the compositor Vivaldi and propose to the residents to listen some extracts of each pieces of music. | Other | Psychosocial stimulation |
Primary outcome
Observed social behaviours
Time frame: during 8 minutes before the session a
social behaviours of residents observed and listed in an observations grid to analyze the results from observation in terms of components of behaviours expressed in means of observed behaviours.
Observed social behaviours
Time frame: during 8 minutes after the session
social behaviours of residents observed and listed in an observations grid to analyze the results from observation in terms of components of behaviours expressed in means of observed behaviours.
5 secondary outcomes
Cognitive Status
Time frame: Baseline
Functional abilities
Time frame: Baseline
Depression
Time frame: Baseline
Psychological and behaviors disorders
Time frame: Baseline
Quality of life
Time frame: Baseline
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 31 Mar 2015.
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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.
Jean-Bernard Mabire principal investigator
University Paris Ouest - EA 4430 - 200, Avenue de la République - 92001 Nanterre cedex
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial stimulation in people with Dementia and Social Interactions, run by Paris West University Nanterre La Défense.
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 1 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 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Observed social behaviours (time frame: during 8 minutes before the session a). 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 31 Mar 2015.