Clinical trial NCT01652222: Experimental Study to Validate the "Therapeutic Game" CONEM-BETA
Official title: Experimental Study to Validate the "Therapeutic Game" CONEM-BETA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Dementia
Keywords: Alzheimer
caregiver
dementia
social support
Montessori
Therapeutic game
Lead sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Sponsor class: OTHER
Collaborators: name: Fundacion SARquavitae
First posted: 2012-07-27
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria Family Caregivers:

* 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

Inclusion Criteria Alzheimer's or dementia person:

* 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.

Exclusion Criteria Caregivers:

* 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

Exclusion Criteria Alzheimer's or dementia person:

* Do not have the sensorial or motor capacities needed for the interaction.
* Serious impairment of the verbal comprehension
* Disabling health conditions

Primary outcomes:
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)
timeFrame: 8 weeks
Secondary outcomes:
measure: 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
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital de Santa Maria
state: Catalonia
city: Salt
country: Spain
facility: Hospital de Salt
state: Catalonia
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua de Terrassa
state: Catalonia
Study officials:
affiliation: SARquavitae, Barcelona, Spain
name: Iciar Ancizu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pasqual Maragall Foundation, Barcelona, Spain
name: Sandra Poudevida, PhD
role: PRINCIPAL_INVESTIGATOR
References: