Support Monitoring and Reminder Technology for Mild Dementia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 10
- 主要终点
- Health Related Quality of Life (HRQL) QoL-AD questionnaire (Thorgrimsen et al. 2003; Rebecca G. Logsdon et al. 2002; R. G. Logsdon et al. 1999)
研究概览
简要总结
This multicentre randomized control trial aims to evaluate the effects of an intervention consisting of an health application developed to improve the quality of life (QoL) in older people with mild dementia and their informal caregivers. The study is a collaboration between five European countries where the clinical trials will be conducted in four of these countries (Sweden, Belgium, Spain and Czech Republic).
In total 1200 dyads (consisting of a person with mild dementia (PWD) and their informal caregiver (carer) will be recruited for this study. Participant dyads will be randomized in a 1:1 ratio in two parallel groups: PWD to receive either usual care from primary or specialized providers (control group) or to receive usual care plus access to a tablet with the SMART4MD health application (intervention group).
Participants in the trial will be assessed for a period of 18 months. After the baseline visit, all participants will have follow-up visits every 6 months together with a checkup of the PWDs capacity to remain in the study. In the follow up visits, investigators will assess the PWD's quality of life, their cognitive and functional status, adherence to prescribed medication and attendance at healthcare appointments and admissions to healthcare services institutions. Investigators will also assess the burden of the informal caregivers.
详细描述
SMART4MD has been developed from an existing general health management application in a process involving the structured participation of PWD, their informal carers, and clinicians.
STANDARD OPERATING PROCEDURES
Participants will be recruited over a period of six months by the nominated/approved licensed providers of relevant medical care at the different sites. Participants will not receive financial reimbursement for taking part in this trial.
Participants will be identified from people with 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 PWD 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 of Consorci Sanitari de Terrassa (CST) and Database of all patients participating in the Swedish National Study on Aging and Care (SNAC). In order to assure that all clinical sites have a similar approach in recruiting participants, a guide with best practices for patient recruitment have been developed.
The following data will be collected in this trial:
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
- 55 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(PWD only):
- •Participants score 20-26 points on Mini-Mental State Examination (MMSE) Participants +55 years of age
- •Male or female. No preference will be given to either
- •Participants are home-care recipients
- •Participants have an informal carer
- •Those participants who take prescribed medication are in charge of their own medication use
- •Participants have no specific conditions reducing their physical ability to use the application to a point that makes their participation in the project impossible, as evaluated by the responsible investigator (the nature of the conditions should be recorded in such cases)
- •The place where the participant is normally resident has sufficient wireless or phone network connectivity to enable them to use SMART4MD on a daily basis
- •Cognitive impairment must have been present for more than six months
排除标准
- •(PWD only):
- •Participants have a terminal illness with <3 years expected survival
- •Participants score above 11 on the Geriatric Depression Scale (GDS-15)
研究组 & 干预措施
Intervention
Participants assigned to the intervention group will have access to the SMART4MD health application and participate in clinical visits every 6 months
干预措施: SMART4MD Health Application (Device)
Control
Participants assigned to the intervention group will NOT have access to the SMART4MD health application and participate in clinical visits every 6 months
结局指标
主要结局
Health Related Quality of Life (HRQL) QoL-AD questionnaire (Thorgrimsen et al. 2003; Rebecca G. Logsdon et al. 2002; R. G. Logsdon et al. 1999)
时间窗: 18 months
This is a 13-item measure which has been specifically designed to measure QoL in individuals with dementia from the perspective of both the PWD and the informal carer. QoL-AD will be assessed via an interview with PWD and via self-completion by informal carers.
次要结局
- Attendance to health care appointments(18 months)
- Zarit Burden Interview (ZBI)(18 months)
- Adherence to medication(18 months)
- Mini mental state examination (MMSE)(18 months)
研究者
Johan Sanmartin Berglund
Professor, MD, PhD
Blekinge Institute of Technology