Experimental Study to Validate the "Therapeutic Game" CONEM-BETA

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Status: Completed

Conditions: Alzheimer's Disease; Dementia

Treatments: Other: CONEM-BETA + socio-educational training; Other: Socio-educational training only

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01652222

CONEM-BETA-FPM/SAR-0111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 3 patient groups

CONEM-BETA + socio-educational training

Experimental group

Description:

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.

Treatment:

Other: CONEM-BETA + socio-educational training

Socio-educational training only

Active Comparator group

Description:

Caregivers will receive the same 4 socioeducational training sessions as the experimental group, during an 8 week period.

Treatment:

Other: Socio-educational training only

Control

No Intervention group

Description:

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