NCT04465812Completed
The Impact of a Smartphone-based Personalized Intervention on Cognitive and Cerebrovascular Health in CIRCLE-CHINA
The Impact of a Smartphone-based Self-monitoring and Personalized Feedback Multiple Intervention on Cognitive and Cerebrovascular Health in CIRCLE-CHINA
Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This smartphone-based personalized multiple intervention study aims to prevent cognitive impairment and reduce dementia and cerebrovascular events in 45-74 year old persons with high risk of stroke in China. The investigators plan to monitor and manage participants' behavioral and health (vascular risk factors control, sleep quality, mental health and cognitive training) based on self-monitoring and personalized feedback via smartphone app. The short-term primary outcome is 1-year change in global cognitive score measured by a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol. The investigators hypothesize that the intervention based on self-monitoring and personalized feedback will prevent cognitive decline by the initial 1-year intervention. The long-term primary outcome is the development of dementia and cerebrovascular events during a total of 5 years' follow-up. The investigators hypothesize that the smartphone-based personalized multiple intervention may reduce the 5-year risk of dementia and cerebrovascular events, mainly through the improvement in vascular risk factors control, sleep quality, mental health and cognitive training activities.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 238 (actual)
- First submitted
- 28 Jun 2020
- Start date
- 21 Jul 2020
- Primary completion date
- 5 Aug 2021
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Stroke
- NCT number
- NCT04465812
What you commit to
- Study type: Interventional
- Participants enrolled: 238
- From 21 Jul 2020 to the primary completion date, 5 Aug 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previously diagnosed dementia
- previously diagnosed stroke (both cerebral infarction and hemorrhage)
- disorders affecting safe engagement in the intervention (eg, malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within 1 year previously)
Other illness
- suspected dementia after clinical assessment by study physician at screening visit
- disorders preventing cooperation as judged by the study physician
Other
- severe loss of vision, hearing, or communicative ability;
- coincident participation in another intervention trial
- any MRI contraindications
Who the study is looking for
- aged 45-74 years
- high risk of stroke (with ≥ 3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack)
Age in the registry: 45 years to 74 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affilated Hospital of Zhejiang University, School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.