Alzheimer's DiseaseNCT01652222
Experimental Study to Validate the "Therapeutic Game" CONEM-BETA
A study testing CONEM-BETA + socio-educational training and Socio-educational training only in people with Alzheimer's Disease and Dementia, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 3 sites in Spain.
Trial summary
The purpose of the study is to assess the efficacy of the systematic application of the CONEM-BETA game in the subjective welfare of family caregivers of patients with Alzheimer's disease or other advanced stage dementia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Dementia
- What is being tested?
- CONEM-BETA + socio-educational training and Socio-educational training only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 3 sitesSpain
- Study dates
- Jan 2012to Aug 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- to be a family caregiver of an person diagnosed with possible or probable Alzheimer's disease or other advanced stage dementia
- show interest in participating
- Sign informed consent
- to have a probable or possible Alzheimer type dementia or other advanced dementia according to a diagnosis done by a Specialized Evaluation Unit
- GDS 5-6 and a minimental equal or lower than 12.
- to preserve a verbal comprehension of basic instructions
- to preserve the mobility of the arms, as well as the visual and auditive capacities that allow to conduct the activities.
Who cannot join
- to have a negative attitude towards the emotional interaction with his/her Alzheimer or dementia family member
- Unavailability
- to participate in other socio-educative interventions during the study period.
- Any other situation that makes the caregiver as not suitable according to investigator's criteria
- Do not have the sensorial or motor capacities needed for the interaction.
- Serious impairment of the verbal comprehension
- Disabling health conditions
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital de Santa Maria
Lleida, Catalonia
Hospital de Salt
Salt, Catalonia
Hospital Universitari Mutua de Terrassa
Terrassa, Catalonia
About this study
The purpose of the study is to assess the efficacy of the systematic application of the CONEM-BETA game in the subjective welfare of family caregivers of patients with Alzheimer's disease or other advanced stage dementia.
Read the detailed description
Alzheimer's disease (AD) is clinically diagnosed based on memory and cognitive deterioration, and the loss of other functional abilities. Nevertheless, for the caregivers and the patients themselves, the psychological and behavioral symptoms of dementia (PBSD) are specially relevant aspects.
These PBSD are a source of stress for the caregiver. PBSD treatment starts with non-pharmacological treatment, but if the symptomatology is moderate to severe, then pharmacological treatments are indicated on top of the non-pharmacological ones. The symptoms that better respond to non-pharmacological interventions are depression and mild apathy, wanderings and repetitive behaviors.
Once dementia progresses, the ability to interact at cognitive and emotional levels are reduced, and then, alternative approaches are needed. In this circumstance, it has been postulated that the caregivers should not try to bring -patients with AD back to the objective reality, but that they should rather empathize with them and establish an emotional connection. This is a complex process, and requires intervention tools that favor this connection and improve the subjective welfare of the caregivers of persons with dementia.
The current study is based on a previous experience in implementing the Montessori method at SARquavitae nursing homes and daycare centers. The "therapeutic game" called CONEM-BETA contains a subset of these activities that have been adapted from the original texts from the Myers Research Institute. We aim to prove that CONEM-BETA may have also socio-emotional benefits for the caregivers when they systematically use them at home with their AD relatives. These potential benefits will be assessed by using validated questionnaires that measure changes in subjective welfare, anxiety and depression, coping strategy, overload level and perceived social support.
- Conditions
- Alzheimer's Disease, Dementia
- Being tested
- CONEM-BETA + socio-educational training, Socio-educational training only
- Keywords
- Alzheimer, caregiver, dementia, social support, Montessori, Therapeutic game
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONEM-BETA + socio-educational trainingOther
4 socio-educative training sessions during 8 weeks, and caregivers will systematically play with their patients with CONEM-BETA therapeutic game during the last 4 weeks. The dyads will be assessed (primary timepoint). Caregivers will then continue using the game with their patients for an extra 6 weeks period as needed, to assess adherence and games preferences.
Socio-educational training onlyOther
4 socio-educative training sessions during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| CONEM-BETA + socio-educational training | Experimental | Caregivers will receive 4 socioeducational training sessions during an 8 week period. These sessions will focus on the description and process of the Alzheimer's disease (AD), and will also provide to the caregivers resources and strategies to cope with AD. During the last 4 weeks, they will also systematically play with the patient at home with the CONEM-BETA game.
After that period, caregivers will use the game based on their preference and frequence during a period of 6 more weeks. Receives: Other: CONEM-BETA + socio-educational training |
| Socio-educational training only | Active comparator | Caregivers will receive the same 4 socioeducational training sessions as the experimental group, during an 8 week period. Receives: Other: Socio-educational training only |
| Control | No intervention | Caregivers of this group will behave with his/her patient during the trial as they have been doing so far, but will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline compared to the control and active arms using the EBP questionnaire (subjective welfare of family caregivers of patients with possible or probable Alzheimer or other advanced stage dementia)
The EBP (Escala de Bienestar Psicologico - Psychological Welfare Scale) assesses the degree of the person self-satisfaction, comfort with himself during a period of his life, and contains four sub-scales: subjective welfare, material welfare, professional welfare and welfare of the relationship with his partner. It allows also to obtain partial scores, that allow to have indicators of overall welfare psychological index, and a weighted score obtained from the items with higher discriminative power
Measured: 8 weeks
Secondary outcomes (5)
change from baseline compared to the control and active arms using the Cornell scale and NPI-Q to assess behaviour of the patients with probable or possible Alzheimer's disease or other advanced stage dementia
Cornell scale assesses the signs associated with depressive disorders in patients with dementia. It contains 19 items that assess 5 dimensions of depression: changes in mood, behavior disorders, physical signs, circadian rhythms, and judgement disorders. NPI-Q is based on NPI (Neuropsychiatric Inventory), and was designed as screening tool to assess the emotional distress of the caregiver. NPI-Q assesses the degree of delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition and irritability.
Measured: 8 weeks
change from baseline compared to the control and active arms using the Martin and cols. scale to assess the overload level of the family caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia
Martin and cols. scale is an adaptation of the Zarit questionnaire to assess the overload level of the caregiver. It is a self administered questionnaire, with 22 items.
Measured: 8 weeks
change from baseline compared to the control and active arms using the Goldberg's scale to assess anxiety and depression of the family caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia
The Goldberg's questionnaire has two subscales with 9 items each, one for anxiety and one for depression. It was originally designed by Goldberg with the aim of having a short interview as a screening tool.
Measured: 8 weeks
change from baseline compared to the control and active arms using the DUKE-UNC scale to assess the perceived social support of the family caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia
Developed for the general population, the DUKE-UNC questionnaire allows to assess the perceived social support. It is self-administered and contains 11 items.
Measured: 8 weeks
change from baseline compared to the control and active arms using the PANAS scale to assess the changes in positive and negative affect of the caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia
The PANAS questionnaire includes 20 items, 10 related to the impact on positive affect (PA), and 10 related to the negative impact in affect (NA).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion SARquavitae
- Responsible party
- Sponsor
- Investigators
- Iciar Ancizu, PhD, Principal investigator, SARquavitae, Barcelona, SpainSandra Poudevida, PhD, Principal investigator, Pasqual Maragall Foundation, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652222
- Sponsor's protocol ID
- CONEM-BETA-FPM/SAR-0111
- Status last verified
- Jul 2014
- First submitted
- 25 Jul 2012
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study to Validate the "Therapeutic Game" CONEM-BETA
- ClinicalTrials.gov ID
- NCT01652222
- Acronym / sponsor ID
- CONEM-BETA-FPM/SAR-0111
- Conditions
- Alzheimer's Disease, Dementia
- Keywords
- Alzheimer, caregiver, dementia, social support, Montessori, Therapeutic game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall FoundationUniversity, hospital or other
- Collaborators
- Fundacion SARquavitae
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Jul 2012 (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 purpose of the study is to assess the efficacy of the systematic application of the CONEM-BETA game in the subjective welfare of family caregivers of patients with Alzheimer's disease or other advanced stage dementia.
Detailed description
Alzheimer's disease (AD) is clinically diagnosed based on memory and cognitive deterioration, and the loss of other functional abilities. Nevertheless, for the caregivers and the patients themselves, the psychological and behavioral symptoms of dementia (PBSD) are specially relevant aspects.
These PBSD are a source of stress for the caregiver. PBSD treatment starts with non-pharmacological treatment, but if the symptomatology is moderate to severe, then pharmacological treatments are indicated on top of the non-pharmacological ones. The symptoms that better respond to non-pharmacological interventions are depression and mild apathy, wanderings and repetitive behaviors.
Once dementia progresses, the ability to interact at cognitive and emotional levels are reduced, and then, alternative approaches are needed. In this circumstance, it has been postulated that the caregivers should not try to bring -patients with AD back to the objective reality, but that they should rather empathize with them and establish an emotional connection. This is a complex process, and requires intervention tools that favor this connection and improve the subjective welfare of the caregivers of persons with dementia.
The current study is based on a previous experience in implementing the Montessori method at SARquavitae nursing homes and daycare centers. The "therapeutic game" called CONEM-BETA contains a subset of these activities that have been adapted from the original texts from the Myers Research Institute. We aim to prove that CONEM-BETA may have also socio-emotional benefits for the caregivers when they systematically use them at home with their AD relatives. These potential benefits will be assessed by using validated questionnaires that measure changes in subjective welfare, anxiety and depression, coping strategy, overload level and perceived social support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONEM-BETA + socio-educational training | Experimental | Other: CONEM-BETA + socio-educational trainingCaregivers will receive 4 socioeducational training sessions during an 8 week period. These sessions will focus on the description and process of the Alzheimer's disease (AD), and will also provide to the caregivers resources and strategies to cope with AD. During the last 4 weeks, they will also systematically play with the patient at home with the CONEM-BETA game. After that period, caregivers will use the game based on their preference and frequence during a period of 6 more weeks. |
| Socio-educational training only | Active comparator | Other: Socio-educational training onlyCaregivers will receive the same 4 socioeducational training sessions as the experimental group, during an 8 week period. |
| Control | No intervention | –Caregivers of this group will behave with his/her patient during the trial as they have been doing so far, but will receive no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- to be a family caregiver of an person diagnosed with possible or probable Alzheimer's disease or other advanced stage dementia
- show interest in participating
- Sign informed consent
- to have a probable or possible Alzheimer type dementia or other advanced dementia according to a diagnosis done by a Specialized Evaluation Unit
- GDS 5-6 and a minimental equal or lower than 12.
Key exclusion criteria (7 listed)
- to have a negative attitude towards the emotional interaction with his/her Alzheimer or dementia family member
- Unavailability
- to participate in other socio-educative interventions during the study period.
- Any other situation that makes the caregiver as not suitable according to investigator's criteria
- Do not have the sensorial or motor capacities needed for the interaction.
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 |
|---|---|---|
| CONEM-BETA + socio-educational training4 socio-educative training sessions during 8 weeks, and caregivers will systematically play with their patients with CONEM-BETA therapeutic game during the last 4 weeks. The dyads will be assessed (primary timepoint). Caregivers will then continue using the game with their patients for an extra 6 weeks period as needed, to assess adherence and games preferences. | Other | CONEM-BETA + socio-educational training |
| Socio-educational training only4 socio-educative training sessions during 8 weeks | Other | Socio-educational training only |
Primary outcome
change from baseline compared to the control and active arms using the EBP questionnaire (subjective welfare of family caregivers of patients with possible or probable Alzheimer or other advanced stage dementia)
Time frame: 8 weeks
The EBP (Escala de Bienestar Psicologico - Psychological Welfare Scale) assesses the degree of the person self-satisfaction, comfort with himself during a period of his life, and contains four sub-scales: subjective welfare, material welfare, professional welfare and welfare of the relationship with his partner. It allows also to obtain partial scores, that allow to have indicators of overall welfare psychological index, and a weighted score obtained from the items with higher discriminative power
5 secondary outcomes
change from baseline compared to the control and active arms using the Cornell scale and NPI-Q to assess behaviour of the patients with probable or possible Alzheimer's disease or other advanced stage dementia
Time frame: 8 weeks
change from baseline compared to the control and active arms using the Martin and cols. scale to assess the overload level of the family caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia
Time frame: 8 weeks
change from baseline compared to the control and active arms using the Goldberg's scale to assess anxiety and depression of the family caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia
Time frame: 8 weeks
change from baseline compared to the control and active arms using the DUKE-UNC scale to assess the perceived social support of the family caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia
Time frame: 8 weeks
change from baseline compared to the control and active arms using the PANAS scale to assess the changes in positive and negative affect of the caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia
Time frame: 8 weeks
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 9 Jul 2014.
- SARquavitae foundation websiteLink provided by the sponsor.
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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.
Iciar Ancizu, PhD principal investigator
SARquavitae, Barcelona, Spain
Sandra Poudevida, PhD principal investigator
Pasqual Maragall Foundation, Barcelona, Spain
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONEM-BETA + socio-educational training and Socio-educational training only in people with Alzheimer's Disease and Dementia, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 3 sites in Spain.
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 7 inclusion and 7 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 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
change from baseline compared to the control and active arms using the EBP questionnaire (subjective welfare of family caregivers of patients with possible or probable Alzheimer or other advanced stage dementia) (time frame: 8 weeks). 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 9 Jul 2014.