The Impact of a Smartphone-based Personalized Intervention on Cognitive and Cerebrovascular Health in CIRCLE-CHINA

Stroke Clinical Trial

Official title:

The Impact of a Smartphone-based Self-monitoring and Personalized Feedback Multiple Intervention on Cognitive and Cerebrovascular Health in CIRCLE-CHINA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465812
• Other study ID #: CIRCLE-CHINA II
• Status: Completed
• Phase: N/A
• Start date: June 21, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: January 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Patients with ≥ 3 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, are regarded as patients with high risk of stroke. Studies have indicated that these stroke risk factors might be associated with an increased risk of cerebral small vessel disease (CSVD) progress, glymphatic dysfunction, cognitive decline, dementia, and cerebrovascular events. However, prevention in these patients is largely unknown and the management of these patients is a very troublesome issue. Previous study has demonstrated that interventions in the feedback and monitoring method could improve exercise adherence in older people compared with other methods including comparison of behavior, social support, natural consequences, identity and goals and planning. Therefore, the investigators plan to monitor and manage vascular risk factors control, sleep quality, mental health and cognitive training based on self-monitoring and personalized feedback on a smartphone app in patients with high risk of stroke. The investigators hypothesize that the intervention based on self-monitoring and personalized feedback will reduce cognitive impairment, glymphatic dysfunction, CSVD progress, depressive symptoms, anxious symptoms, improve sleep quality, and reduce dementia and cerebrovascular events incidence in the study group compared to the control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: March 31, 2024
• Est. primary completion date: August 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 74 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• previously diagnosed dementia

• previously diagnosed stroke (both cerebral infarction and hemorrhage)

• suspected dementia after clinical assessment by study physician at screening visit

• disorders affecting safe engagement in the intervention (eg, malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within 1 year previously)

• severe loss of vision, hearing, or communicative ability;

• disorders preventing cooperation as judged by the study physician

• coincident participation in another intervention trial

• any MRI contraindications

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Stroke

Intervention

Behavioral:
• Self-monitoring and personalized feedback on smartphone app
Patients will record their blood pressure (once 1-week for patients with hypertension, every 3-month for those without), blood glucose (once 1-month for patients with diabetes), serum lipid metabolism (every 3-month for patients with dyslipidemia) on app, and medical staff will suggest continuing monitoring and recording or recommend outpatient visit; Patients will complete Pittsburgh sleep quality index test on app every 3-month, and medical staff will contact with patients with index > 15 to assess detail clinical status and recommend outpatient visit if necessary; Patients will complete Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) on app every 3-month, and medical staff will contact with patients with SAS>49 or SDS>52 to assess detail clinical status and recommend outpatient visit if necessary; Patients will complete cognitive training games every week on app; Medical staff will send health information on app

Locations

Country	Name	City	State
China	Second Affilated Hospital of Zhejiang University, School of Medicine	HangZhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Shaoxing Doumen Street Community Health Service Center, Shaoxing Gaobu Street Community Health Service Center, Shaoxing Mashan Street Community Health Service Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol	Short-term Primary Outcome	1 year
Primary	Dementia and cerebrovascular events incidence	Long-term Primary Outcome	5 years
Secondary	Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI	Short-term Secondary Outcome	1 year
Secondary	Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI	Short-term Secondary Outcome	1 year
Secondary	Cognitive function change assessed by scores of Mini-Mental State Examination (MMSE) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	Short-term Secondary Outcome	1 year
Secondary	Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	Short-term Secondary Outcome	1 year
Secondary	Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)	Short-term Secondary Outcome	1 year
Secondary	Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)	Short-term Secondary Outcome	1 year
Secondary	Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)	Short-term Secondary Outcome	1 year
Secondary	Dementia and cerebrovascular events incidence	Short-term Secondary Outcome	1 year
Secondary	Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol	Long-term Secondary Outcome	5 years
Secondary	Cognitive function change assessed by scores of Mini-Mental State Examination (MMSE) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	Long-term Secondary Outcome	5 years
Secondary	Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	Long-term Secondary Outcome	5 years
Secondary	Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI	Long-term Secondary Outcome	5 years
Secondary	Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI	Long-term Secondary Outcome	5 years
Secondary	Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)	Long-term Secondary Outcome	5 years
Secondary	Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)	Long-term Secondary Outcome	5 years
Secondary	Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)	Long-term Secondary Outcome	5 years
Secondary	Dementia and cerebrovascular events incidence	Long-term Secondary Outcome	3 years
Secondary	Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol	Long-term Secondary Outcome	3 years
Secondary	Cognitive function change assessed by scores of Mini-Mental State Examination (MMSE) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	Long-term Secondary Outcome	3 years
Secondary	Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	Long-term Secondary Outcome	3 years
Secondary	Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI	Long-term Secondary Outcome	3 years
Secondary	Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI	Long-term Secondary Outcome	3 years
Secondary	Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)	Long-term Secondary Outcome	3 years
Secondary	Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)	Long-term Secondary Outcome	3 years
Secondary	Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)	Long-term Secondary Outcome	3 years