OK en Casa - ZAINDOO an Online Support Program for Caregivers of People With Dementia, a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Burden
研究概览
简要总结
There are currently 50 million people in the world diagnosed with dementia. Due to the detrimental impact on the mental and physical health of family caregivers different online interventions have been developed in order to improve their well-being. In this paper, we describe the design of a randomized controlled trial aiming to study the impact of a multicomponent online program on primary and secondary caregivers of a person with dementia (PWD).
The experimental group will receive the intervention which is a multicomponent program based on different components, among others; online psychoeducation, training on psychological skills, a forum with other caregivers and interaction with a psychologist. Caregivers in the control group will follow their lifestyle.
More than 250 participants (primary and secondary caregivers) are expected to be recruited via several sources in the province of Guipuzcoa in Spain. The inclusion criteria for the primary caregiver are: a) being 18 years or older; b) being the primary caregiver of the PWD; c) more than 6 months caring; and d) give more than 1 hour of caregiving per day. The outcomes of this trial are caregiver burden (primary outcome), perceived health, depression and anxiety, social support, satisfaction with care and with the treatment and stress caused by the problem behaviour of the PWD (secondary outcomes).
详细描述
Aim: to analyze the effectiveness of a multicomponent online program on primary and secondary caregivers of a person with dementia.
Methods and analyses: The trial design is a two group randomized controlled trial to establish the effectiveness of an online support program. The experimental group will complete the program for 9 months and the control group will continue with their usual lifestyle. The objective is to examine the effect of this online support program on burden as primary outcome. Secondary outcomes of the study are social support, perceived health, anxiety, depression, satisfaction with caregiving, stress derived from the memory and behaviour problems of the person with dementia and satisfaction with treatment. The intervention will last for 9 months in total and includes two measurements, pre and post measure (9 months after) for the experimental and control group. The trial is set in Spain, concretely in The Basque Country.
OK en casa - Zaindoo: online support program for caregivers of persons with dementia. The multicomponent online programme is composed of the following components:
Assessment: In this section are placed the assessment tools that the caregiver must complet online before and after the intervention. The questionnaires collect information regarding the care context, health (perceived health, depression and anxiety), burden, satisfaction with care, family support and formal support (instrument created ad hoc).
My status: It offers information and feedback on the context of care, health and the socio-emotional status of the caregiver. It is composed of six blocks (context of care, health, burden, satisfaction with care, family support and formal support). The information offered to the caregiver is based on a system of colours that oscillates between green (optimal situation) and red (critical situation). Thus, and for each of the blocks indicated above, if the caregiver is in an optimal state or have few difficulties the green colour is shown. If has mild symptoms or difficulties in the care context the yellow colour is shown, the orange would represent moderate symptoms and difficulties and finally, the red colour is indicative of a critical socio-emotional situation or serious difficulties in the context of care. Likewise, a single colour is shown as a summary that reflects the general situation of the caregiver, respecting the order of the colours that have been explained above. The colour corresponding to each of the blocks and the one regarding the general situation is accompanied by a text that summarizes caregivers situation using a positive language.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The random assignment of the participants was carried out according to the following criteria: 1) Prepare an unpredictable sequence of random numbers; and, 2) Keep this sequence hidden until the assignment was carried out. To hide the sequence, the person in charge of the random assignment was maintained out of the recruitment and pre-treatment evaluation.
The assignment was carried out controlling the following variables: sex, age (over or under 60 years), burden (score> 17 in the Reduced Zarit caregiver burden interview), attendance or not to the SENDIAN program (psychological support users) and / or support groups or non-users) of the primary caregiver and the level of dependence of the elderly person with dementia (mild / moderate or severe).
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be the main caregiver of the person with dementia
- •To be over 18 years of age
- •Provision of at least 6 months of care
- •Provide at least one hour of care per day.
排除标准
- •Having a contractual relationship for caring issues with the elderly person with dementia or with its family
- •Have a disease that makes participation difficult during this pilot study (18 months)
- •Not to have dementia.
研究组 & 干预措施
to analyze the effectiveness of Ok en Casa Zaindoo
The multicomponent online programme is composed of the components explained in the detailed study description:
干预措施: OK EN CASA-ZAINDOO (Other)
结局指标
主要结局
Burden
时间窗: Day 0, Month 0 and Day 0, Month 9
Reduced Zarit burden scale (ZBI, Regueiro Pérez, Gómara \& Ferreiro, 2007). It consists of 7 items that measures the perceived burden of caregivers via 5-point Likert scale items (0 = never, 1 = almost never, 2 = sometimes, 3 = many times, and 4 = almost always). This instrument establishes different degrees of overload depending on the score obtained. Scores lower than 17 are indicative that there is no overload, while scores higher than 17 indicate the existence of it.
次要结局
- Anxiety and depression(Day 0, Month 0 and Day 0, Month 9)
- Memory and behavior problems(Day 0, Month 0 and Day 0, Month 9)
- Health status(Day 0, Month 0 and Day 0, Month 9)
- Satisfaction with care(Day 0, Month 0 and Day 0, Month 9)
- Social support(Day 0, Month 0 and Day 0, Month 9)
- Satisfaction with the treatment(Day 0, Month 0 and Day 0, Month 9)
研究者
Igone Etxeberria
Principal Investigator
University of the Basque Country (UPV/EHU)