Multicomponent Intervention With Healthy Lifestyle Psychoeducation and Cognitive Stimulation to Improve Cognitive Abilities in Older Adults With Mild Cognitive Impairment-A Double-blind Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Chinese Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
研究概览
简要总结
The research aims to investigate the effectiveness of a new short-term multicomponent intervention to promote the bio-psycho-social-spiritual health of older adults with MCI to improve their cognitive abilities.
In this study, the multicomponent intervention consists of healthy lifestyle psychoeducation and cognitive stimulation. This study is a double-blind, clustered, randomized, controlled, four-arm parallel group study. 200 eligible older adults with MCI are openly recruited into activity groups in local elderly centres. The activity groups are randomly allocated to three intervention groups (i.e., multicomponent intervention, cognitive stimulation and lifestyle psychoeducation) and a control group in a 1:1:1:1 ratio. The participants with MCI are blinded on group allocation and kept uninformed which type of intervention they are receiving. An investigator, blinded to group allocation and intervention, assess outcomes using standardized assessment tools before and after the intervention and after 3 months.
详细描述
Background. Mild cognitive impairment (MCI) is an intermediate stage between cognitively healthy ageing and dementia, with a prevalence rate of 15.6% in older adults worldwide. Older adults with MCI have a higher risk of developing dementia than older people without MCI. Multicomponent interventions that promote a healthy lifestyle to improve cognitive abilities are promising and more favorable than single interventions for older adults with MCI. However, there is a lack of short-term and effective multicomponent interventions.
Objective
This study aims to evaluate the effectiveness of a new short-term multicomponent intervention based on the Integrative Body-Mind-Spiritual Model, an Eastern health care approach that aims to promote the bio-psycho-social-spiritual health of older adults with MCI to improve their cognitive abilities. The multicomponent intervention provides healthy lifestyle psychoeducation and cognitive stimulation, delivered by social workers within 12-weeks. The efficacy and effect sizes of the multicomponent intervention will be compared with those of two single interventions, i.e. healthy lifestyle psychoeducation and cognitive stimulation. The underlying mechanism of change will be investigated.
Hypothesis
(i) the multicomponent intervention leads to significant improvement in cognitive ability, anxiety, depression, healthy lifestyle behavior, and subjective well-being in older adults with MCI at both post-intervention and 3-month follow-up; (ii) the multicomponent intervention leads to larger intervention effects compared to the two single interventions, i.e., cognitive stimulation and lifestyle psychoeducation; and (iii) improvement in cognitive ability is predicted by improvement in healthy lifestyle behavior, depressive and anxiety symptoms.
Research methods: This study is a double-blind, clustered, randomized, controlled, four-arm parallel group study. 200 eligible older adults with MCI are openly recruited into activity groups in local elderly centres. The activity groups are randomly allocated to three intervention groups (i.e., multicomponent intervention, cognitive stimulation and lifestyle psychoeducation) and a control group in a 1:1:1:1 ratio. The participants with MCI are blinded on group allocation and kept uninformed which type of intervention they are receiving. An investigator, blinded to group allocation and intervention, assess outcomes using standardized assessment tools before and after the intervention and after 3 months. A previous pilot study of the multicomponent intervention yielded positive outcomes, supporting the feasibility of this study.
Significance: This study aims to make a seminal contribution to theoretical advances in the application of Integrative Body-Mind-Spiritual Model in multicomponent interventions to improve the cognitive abilities of older adults with MCI through the promotion of bio-psycho-social-spiritual health, and to investigate its effectiveness and underlying mechanism of change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
A research staff, who is blinded to the group allocation and does not involve in the delivery of group interventions, conduct the intervention outcomes assessment of the participants before and after the intervention and after 3 months.
The participants with MCI are blinded on group allocation and kept uninformed which type of intervention they are receiving.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria:
- •age 60 years or older;
- •diagnosis of MCI or mild neurocognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorder (Fifth edition, Text Revision) (American Psychiatric Association, 2022); Participants who are not diagnosed with MCI will undergo a screening assessment by a research assistant using both the Montreal Cognitive Assessment (MoCA) (Chinese version) with a total score of 19 to 21 represents MCI. (Yeung et al., 2014);
- •awareness of memory loss with memory complaints;
- •member of collaborating elderly centre;
- •able to participate independently in group activities; and
- •fluent in Cantonese.
排除标准
- •diagnosed with dementia;
- •unable to participate independently in group activities;
- •exhibiting disruptive behavior; and
- •severely impaired by physical disabilities (e.g. a severe hearing problem)
研究组 & 干预措施
Multicomponent intervention (HBHG)
HBHG provides cognitive stimulation and lifestyle psychoeducation, with a total of 12 sessions, one sessions per week, with each session lasting approximately 45 minutes and led by a social worker.
干预措施: Multicomponent intervention (Behavioral)
Cognitive stimulation (CS)
CS provides 12 sessions of mentally stimulating activities, one session per week, each lasting approximately 45 minutes and led by a social worker
干预措施: Cognitive stimulation (Behavioral)
Lifestyle psychoeducation
Lifestyle psychoeducation provides 12 psychoeducation sessions on healthy lifestyles, one session per week, each session lasts about 45 minutes and is led by a social worker
干预措施: Lifestyle Education (Behavioral)
Active Control
Active control provides both sham cognitive stimulation and sham lifestyle psychoeducation
干预措施: Sham Lifestyle Psychoeducation (Behavioral)
结局指标
主要结局
Chinese Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
时间窗: It will be used before and after the intervention and 3 month follow up (over 26-weeks)
The ADAS-Cog has good validity and internal consistency (Cronbach's α = 0.9; Chu et al., 2000), and covers eleven cognitive tasks, including word recall (e.g. a list of 10 words is read by the subject, and then the subject is asked to verbally recall as many of the words as possible), naming objects and fingers, commands, constructional praxis, ideational praxis, orientation, word recognition, language, comprehension of spoken language, and word finding difficulty
Chinese Montreal Cognitive Assessment (MoCA)
时间窗: It will be used before and after the intervention and 3-month follow up (over 26-weeks)
• The MoCA has satisfactory validity, internal consistency (Cronbach's α = 0.8; Yeung et al., 2014), and is widely used for screening and assessment of MCI (Chen et al, 2021). It assesses global and specific cognitive abilities, including memory recall (e.g., I read some words to you earlier, which I asked you to remember. Tell me as many of those words as you can remember), attention, concentration, executive functions, language, visuospatial skills, abstract reasoning, calculation and orientation (Yeung et al., 2014).
次要结局
- Chinese Geriatric Anxiety Inventory (GAI)(It will be used before and after the intervention and 3-month follow up (over 26-weeks))
- Chinese Geriatric Depression Scale (GDS)(It will be used before and after the intervention and 3-month follow up (over 26-weeks))
- Chinese Health-Promoting Lifestyle Profile-Short form (HPLP-SF)(It will be used before and after the intervention and 3-month follow up (over 26-weeks))
- Chinese WHO 5-item Well-Being Index (WHO-5)(It will be used before and after the intervention and 3-month follow up (over 26-weeks))
研究者
Daniel Young
Professor
City University of Hong Kong