TV-based Assistive Integrated Service to Support European Adults Living With Mild Dementia or Mild Cognitive Impariment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 404
- 试验地点
- 4
- 主要终点
- Change from baseline quality of life in people with mild cognitive impairment or mild dementia at 6 and 12 months.
研究概览
简要总结
This multicentre randomized controlled trial aims to evaluate the effects of an intervention consisting of a TV-based Assistive Integrated Service developed to improve the quality of life in older people with mild cognitive impairment or mild dementia (PMCI/MD) and their informal caregivers. This study is a collaboration between four European countries (Spain, Romania, Italy and Switzerland) and the clinical trials will be conducted in two of these countries (Spain and Romania) In total 240 dyads, consisting of a person with mild cognitive impairment or mild dementia and their informal caregiver will be recruited for this study. Participant dyads will be randomized in a 1:1 ratio in two parallel groups: to receive either usual care from primary or specialized providers (control group) or to receive usual care plus access to a device with the Tv-AssistDem platform (intervention group).
Participants in the trial will be assessed for a period of 12 months. After the baseline visit, all participants will have follow-up visits every 6 months together with a checkup of the PMCI/MD capacity to remain in the study. In the follow up visits, investigators will assess the PMCI/MD quality of life, caregiver's quality of life and burden, patient treatment adherence, patient functional status and service utilization. A user-behaviour analysis and usability evaluation will also be performed.
详细描述
TV-AssistDem is an interactive platform which has been designed and developed adapting the functionalities and content to best fit PMCI/MD, in a process involving the structured participation of PMCI/MD, their informal caregivers, and clinicians.
QUALITY ASSURANCE PLAN. The researchers will review and report the process during the trial covering participant enrolment, consent, eligibility and allocation to trial groups, policies to protect participants, including reporting of harm and completeness, accuracy and timeliness of data collection.
STANDARD OPERATING PROCEDURES. Participants will be recruited over a period of three months by physicians (primary care, psychiatry, neurology, and geriatrics), neuropsychologists and dementia and mental health nurses. Participants will not receive financial reimbursement for taking part in this trial. Participants will be identified from people with self- perceived cognitive impairment or caregiver´s perception of cognitive impairment that has been present for more than six months and who meet all the study eligibility criteria (listed in section Eligibility). The Mini-Mental State Examination (MMSE) and Geriatric Depression Scale (GDS-15) will be used to screen PMCI/MD at recruitment. Participants can be under primary care services as well as secondary care services. Participants will also be identified from patient databases such as those integrated in the network.
DATA DICTIONARY. All variables collected in this study are listed and described in an electronic case report form, with associated guidelines, to ensure consistency in all gathered data. The following data will be collected in this trial:
- Sociodemographical data.
- Medical history - PMCI/MD only.
- Quality of Life-Alzheimer's Disease Scale (QoL-AD Scale) (1-3).
- European Quality of Life 5 Dimensions 5 Levels (EuroQoL-5D-5L) (4,5).
- Zarit Burden Interview (ZBI-12) (6,7).
- Treatment adherence: Pill/dose count (8-10) and Morisky-Green Test (11).
- Functional decline: Lawton - Brody Instrumental Activities Of Daily Living Scale (IADL) (12).
- Service Utilisation: Client Service Receipt Inventory (CSRI) (13,14).
- Data from the TV-AssistDem application focusing on User-behaviour and usage of core services.
- Usability Evaluation: System Usability Scale (SUS) (15,16).
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants score 23-27 points on Mini-Mental State Examination (MMSE).
- •Self-perceived cognitive impairment or caregiver´s perception of cognitive impairment that has been present for more than six months.
- •Participants +60 years of age.
- •Participants live independently.
- •Participants have an informal caregiver.
- •Participants who take prescribed medication are in charge of their own medication use.
- •Participant with pharmacological treatment for a chronic conditions during study period.
- •The place where the participant is normally resident has enough wireless or phone network connectivity to enable them to use Tv-AssistDem platform on a daily basis.
- •Participants agree to be part of the study by giving signed written consent.
排除标准
- •Participants have a terminal illness with <3 years expected survival.
- •Participants score above 11 on the Geriatric Depression Scale (GDS-15).
- •Participants have specific conditions reducing their physical ability to use the application to a point that makes their participation in the project impossible (the nature of the conditions will be recorded in such cases).
结局指标
主要结局
Change from baseline quality of life in people with mild cognitive impairment or mild dementia at 6 and 12 months.
时间窗: At baseline and then at 6 and 12 months.
Quality of Life-Alzheimer's Disease Scale (QoL-AD Scale) (1-3) is an instrument specifically designed to measure quality of life in people with dementia from the perspective of both the patient and the informal caregiver. It is a 13-item measure, which includes assessments of the person´s relationships with friends and family, financial situation, physical condition, mood, memory and an overall assessment of life quality. Response options are 4-point multiple choice options (1 = poor, 2= fair, 3= good, 4 = excellent). Scale scores range from 13 to 52, with higher scores indicating greater quality of life. PMCI/MD may lose cognitive function during the study to the extent that they are unable to complete the assessments themselves. For this reason, informal caregivers will also complete the QoL-AD, in parallel and on behalf of the PMCI/MD, from the start of the study.
次要结局
- Change from baseline burden in informal caregivers at 6 and 12 months.(At baseline and then at 6 and 12 months.)
- Change from baseline quality of life in informal caregivers at 6 and 12 months.(At baseline and then at 6 and 12 months.)
- Change from baseline treatment adherence in people with mild cognitive impairment or mild dementia at 6 and 12 months.(At baseline and then at 6 and 12 months.)
- Change from baseline functional decline in people with mild cognitive impairment or mild dementia at 6 and 12 months.(At baseline and then at 6 and 12 months.)
- Change from baseline treatment compliance in people with mild cognitive impairment or mild dementia at 6 and 12 months.(At baseline and then at 6 and 12 months.)
- Change from baseline healthcare costs at 12 months(At baseline and then at 12 months)