Playful Multimodal Intervention, Monitoring and Decision Support for Activation of People With Alzheimer's Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Neuropsychological Test Battery
研究概览
简要总结
The worldwide prevalence of dementia is increasing. Pharmaceutical therapies, at the best, slow the degenerative process, observable in Alzheimer's disease (AD). Additional approaches are therefore urgently needed to maintain the patient's independence and the abilities to execute activities of daily living to reduce the patient specific, familial and economic burden. Multimodal tablet-based training might be a potential linchpin in this quest. The primary aim of this study therefore is, to examine the efficacy of the tablet-based training program "Multimodal Activation" (MMA) in mild AD patients.
In a randomized controlled trial the investigators aim to include 220 mild AD patients, of which 110 are randomly assigned to the training group receiving guided tablet-based training for 1.5 years, and 110 to the control group. The multimodal intervention, as implemented in the training, includes physical, cognitive and social components. Efficacy of the training will be determined by means of between group pre-post comparison in quantitative neuropsychological and qualitative tests, MRI biomarker and blood biomarker.
详细描述
Background. The prevalence of Alzheimer's disease is increasing due to an aging society. Parallel, care and nursing needs and costs rise with disease progression. Promoting and stimulating patients to maintain patients abilities and the independent life is therefore essential to prolong the time at home and reduce direct and indirect costs. Computer-based technologies, such as tablet-based trainings, might have the potential to support the patient itself and the caregiver by reducing the (nursing) care-dependency and stabilizing or slowing the disease progression. Prior studies revealed that patients suffering from dementia in general desire technologies supporting cognitive abilities, communication skills, social integration and activities of daily living (e.g. mobility) (Lauriks et al .2007, Wand et al., 2016). Moreover, a multimodal approach has been demonstrated to be superior compared to unimodal approaches, aiming to foster only one domain or aspect. In this study, a multimodal tablet-based training, focusing on cognitive, psychological, physical and aspects of activities of daily living, for patients suffering from mild Alzheimer's disease was implemented.
The primary aim of this study is to examine the efficacy of the multi-domain approach which as implemented in the tablet-based training in mild AD patients. Secondary aims are to measures structural and functional cerebral changes, quality of life, mobility, motivation, life-style factors, stress, care-dependency, (instrumental) activities of daily living, changes in medical treatments, problems in behavior, burden due to nursing, activity level, arm strength, depressive symptoms and the usability of the data raised for the development of a decision support system.
Methods. This study is implemented as a randomized controlled trial with embedded design. Two-hundred twenty subjects with mild AD (dementia diagnoses according to NINCDS-ADRDA criteria) and the primary caregiver will be included in the study. One hundred ten subjects will receive a guided tablet-training for 1.5 years. One hundred ten subjects are in the control group, receiving "normal" medical treatment and support. Additionally, five nursing persons and 5 M.A.S. (Morbus Alzheimer syndrome) trainers conduct single and group trainings. All subjects and the caregivers will be tested and interviewed, respectively, at study entry, at six, twelve and eighteen months. The study team consist of Joanneum Research (JR), the Sozialverein Deutschlandsberg (SVDL), the Austrian Red Cross (ÖRK), and the Medical University of Graz, Department of Neurology and the Institute of Nursing Science as well as Health System & Intelligence (HS&I).
Recruiting. The recruiting process is carried by telephone, flyer, home page, personal meetings, and social media. The approach is convenience sampling.
Randomisation. In advance of the study, a randomisation concept determines the participant's random assignment to intervention or control group. The first half of the 220 participants are 70% likely to be assigned to the intervention group and 30% to the control group. For the second half of the sample the likelihood for group assignment reverses. This step should guarantee that enough participants receive the intervention in case of challenging recruitment. The intervention is favoured over an equal distribution to the groups. At the University Clinic of Neurology, where the examination takes place, only a study nurse knows about the group assignment of the patients, forwarding this information to the personnel of the SVDL and the ÖRK.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
盲法说明
Neurologist and neuropsychologist are not informed about intervention
入排标准
- 年龄范围
- 50 Years 至 101 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with dementia
- •are diagnosed of possible or probable dementia according to NINCDS-ADRDA criteria (McKhann et al. 2011).
- •are older than 40 years at baseline examination.
- •are able to speak and understand German and possesses sufficient physical, auditory and visual faculties to take part in a neuropsychological examination and a tablet-based training.
- •have been receiving stable medication therapy for a minimum of 3 months before the baseline examination.
- •who have been treated with a Memantine therapy, which started 3 months before the baseline examination.
- •will be accompanied to the neurological examinations at T0a and T3a at the University Clinic of Neurology by an informal caregiver (relative or other significant person).
- •may receive professional 24-hours-care - in this case an informal caregiver must be recruited as participant/accompanying person.
- •live at home, with or without an informal caregiver (if alone, an informal caregiver should live nearby).
- •receive professional care (e.g. home care services) or informal care (e.g. relatives) or no care yet.
- •are willing and able to give informed consent or an informal caregiver with power of representation or a trustee gives the informed consent to participation in the study.
- •do not receive any antipsychotic or antidepressive medication or have been stably adjusted to the medication for a minimum of 14 days before study start.
- •Informal caregivers
- •are significant persons (e.g. family members, friends) of the participating persons with dementia (adults) which provide or do not provide care.
- •living or not living with the person with dementia in the same household.
- •are associated with a person with dementia receiving or not receiving professional care.
- •speak and understand German.
- •are able to give informed consent to participation in the study.
- •Dementia trainers
- •are adults.
- •are trained as M.A.S. (Morbus Alzheimer Syndrome) trainer.
- •train the participants with dementia at home.
- •speak and understand German.
- •are able to give informed consent to participation in the study.
排除标准
- •Participation in a clinical trial until the last three months before study entry
- •The participant presumably cannot finish the study
- •Any of the following signs in brain MRI:
- •Infarct close to major vessels
- •More than one lacunar infarction (diameter 1.5cm in every spatial direction)
- •One lacunar infarct in a strategic region, such as the thalamus, the hippocampus or the caudate nucleus
- •Confluent lesions in deep white matter (Fazekas Score 3)
- •Other focal lesions potentially causing cognitive status (e.g. infections, lesions, normal pressure hydrocephalus)
- •A general anesthetic three months before study entry or during study period
- •The participant has a immunomodulating treatment or will receive a immunomodulating treatment during study period
- •Cancer (last treatment >=5 years before study entry)
- •Myocard infarction within 2 years before study entry
- •Hepatitis B, C, HIV, Syphilis
- •The patient has an active contagious disease
- •The patient has a systemic disease potentially causing rapid progression
- •Insufficiently treated cardiac insufficiency (NYHA>3)
- •Insufficiently treated diabetes
- •Renal failure
- •Chronic liver disease
- •Other clinically relevant systemic diseases
- •The Patient suffers from hypothyreosis. Patients with treated hypothyreosis may participate if stable therapy since >3 months is given
- •Psychiatric diseases, such as schizophrenia, psychotic diseases or a bipolar disease
- •Current depressive episode or major depression within the last 2 years before study entry
- •Metabolic or toxic encephalopathy or dementia due to general medical conditions
结局指标
主要结局
Neuropsychological Test Battery
时间窗: day 0, month 18
Pre-post comparisons in cognitive assessment's composite scores will used for efficacy of the tablet-training. The following z-transformed scores will be used to calculate a composite score: Wechsler Memory Scale (WMS-III-R) : Visuelle Paarerkennung I (min-ma:0-18, higher= better) Wechsler Memory Scale (WMS-III-R) : Verbale Paarerkennung I (min-ma:0-24, higher=better) Wechsler Memory Scale (WMS-III-R) : digit span (min-max: Trail Making Test, Version A (min-max: 0-180 seconds, lower better) Trail Making Test, Version B (min-max: 0-300 seconds, lower better) Verbaler Lern- und Merkfähigkeitstest, Subscore "Lernen und Datenakquisition" (min-ma:0-75, higher better) Testbatterie zur Aufmerksamkeitsprüfung (min-ma:0-n.a., lower better) Regensburger Wortflüssigkeitstest (verbal fluency test; 0-max, higher better); Letter Digit Subsitution Test (90 sec)
Change of cognition (persons with dementia)
时间窗: day 0, month 6, month 12, month 18
The "Montreal Cognitive Assessment" has 30 items in 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. 0-30 points can be obtained. Lower scores indicate a higher degree of cognitive impairment.
次要结局
- Change of care dependency (persons with dementia)(day 0, month 18)
- Change of the activity level (persons with dementia)(day 0, month 18)
- Change of care burden (informal caregivers)(day 0, month 18)
- Change of mobility (persons with dementia)(day 0, month 18)
- Change of quality of life (persons with dementia)(day 0, month 18)
- Change of lifestyle factors (persons with dementia)(day 0, month 6, month 12, month 18)
- Change of depression (persons with dementia)(day 0, month 18)
- Total Brain Volume measured with MRI(day 0, month 18)
- Change of motivation (persons with dementia)(day 0, month 18 (AES self); day 0, month 6, month 12, month 18 (AES proxy, FAM))
- Technology acceptance (persons with dementia, informal caregivers, dementia trainers)(day 0, month 18; Interviews after 6 months)
- Change of perceived stress (informal caregivers)(day 0, month 18)
- Local Brain Volume measured with MRI(day 0, month 18)