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

NCT ID: NCT01652222

Last Updated: 2014-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-08-31

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.

Conditions

Alzheimer's Disease; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CONEM-BETA + socio-educational training

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.

Group Type: EXPERIMENTAL

CONEM-BETA + socio-educational training

Intervention Type: OTHER

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 only

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

Group Type: ACTIVE_COMPARATOR

Socio-educational training only

Intervention Type: OTHER

4 socio-educative training sessions during 8 weeks

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CONEM-BETA + socio-educational training

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.

Intervention Type: OTHER

Socio-educational training only

4 socio-educative training sessions during 8 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundacion SARquavitae

INDUSTRY

Sponsor Role: collaborator

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iciar Ancizu, PhD

Role: PRINCIPAL_INVESTIGATOR

SARquavitae, Barcelona, Spain

Sandra Poudevida, PhD

Role: PRINCIPAL_INVESTIGATOR

Pasqual Maragall Foundation, Barcelona, Spain

Locations

Hospital de Santa Maria

Lleida, Catalonia, Spain

Hospital de Salt

Salt, Catalonia, Spain

Hospital Universitari Mutua de Terrassa

Terrassa, Catalonia, Spain

Countries

Spain

Other Identifiers

CONEM-BETA-FPM/SAR-0111

Identifier Type: -

Identifier Source: org_study_id