Experimental Study to Validate the "Therapeutic Game" CONEM-BETA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 3
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- •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
结局指标
主要结局
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)
时间窗: 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
次要结局
- 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(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(8 weeks)
- 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(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(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(8 weeks)