Impact of the Digital Multi-domain Cognitive Intervention in High-risk Populations for Dementia

Dementia is a chronic, progressive neurodegenerative disease characterized by acquired cognitive impairment as its core manifestation. The most common type of dementia is Alzheimer's Disease (AD), also known as "Senile Dementia," accounting for 60-80% of all dementia cases. Currently, there are approximately 10 million AD patients in China, with the number showing an increasing trend year by year, imposing a heavy economic and caregiving burden on families and society. Studies have shown that AD has a clinically silent period of 15 to 20 years (SCD\MCI), where the risk of developing dementia is ten times higher than that of healthy elderly individuals. Nearly 50% of MCI patients progress to dementia within 5 years, and about 14.1% of SCD patients develop dementia within the same timeframe. Early detection, diagnosis, and intervention are currently the most effective strategies for preventing and treating AD. Therefore, this study aims to verify the intervention effect of integrated cognitive intervention in high-risk populations for senile dementia (SCD, MCI) based on the cognitive rehabilitation model through randomized controlled trials, and to analyze attrition rates, participation rates, etc., which have good research and application value.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Dysfunction
• Intervention / Treatment: Behavioral: Multi-domain Cognitive Intervention

Detailed Description

Based on the cognitive rehabilitation model, this study aims to develop a digital multimodal cognitive intervention program, and conduct feasibility studies and randomized controlled trials. The intervention includes health knowledge education, exercise intervention, art intervention, and cognitive training, etc. The feasibility, effectiveness, and safety of this intervention approach will be evaluated.

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: lian fayang, MD; Phone Number: 86 0591-87557768; Email: fjslkyk@163.com
• Study Contact Backup: Name: Yuanjiao Yan, PhD; Phone Number: 86 18120826271; Email: yuanjiao1994@126.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Provincial Hospital
      • Contact: yuanjiao yan, PhD; Phone Number: +8618120826271; Email: yuanjiao1994@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• MCI (refer to Peterson's diagnostic criteria) or SCD (refer to the diagnostic framework proposed by Jak bondi and Jessen et al.);
• Able to communicate normally in Mandarin;
• Certain level of comprehension and judgment abilities, aware of the purpose of the survey and consents to participate.

Exclusion Criteria:

• Patients with dementia exhibiting abnormal mental behavior;
• Individuals with severe hearing or speech impairments;
• Those with serious physical illnesses who are unable to cooperate and complete the survey.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants in the intervention group received the digtal multi-domain cognitive intervention. The digital multi-domain cognitive intervention system is used to carry out various intervention activities. The activities include learning about health knowledge once a week; home-based exercise three times per week, for 30 minutes each time; art therapy once a week, for 90 minutes at a time; and cognitive training, which includes memory, attention, executive function, and visuospatial training, conducted three times per week, with each session lasting 30 minutes.	Behavioral: Multi-domain Cognitive Intervention; Cognitive rehabilitation includes home-based exercise, three times per week, for 30 minutes each session.Cognitive stimulation involves art therapy, once a week, for 90 minutes per session.Cognitive training encompasses memory, attention, executive function, and visuospatial training, conducted three times per week, with each session lasting 30 minutes.Health education, once a week, covering the prevention and treatment of chronic diseases in the elderly, as well as healthy lifestyles for the elderly.
Other: Control group; Participant in the control group reveived the health education , once a week, covering the prevention and treatment of chronic diseases in the elderly, as well as healthy lifestyles for the elderly	Behavioral: Multi-domain Cognitive Intervention; Cognitive rehabilitation includes home-based exercise, three times per week, for 30 minutes each session.Cognitive stimulation involves art therapy, once a week, for 90 minutes per session.Cognitive training encompasses memory, attention, executive function, and visuospatial training, conducted three times per week, with each session lasting 30 minutes.Health education, once a week, covering the prevention and treatment of chronic diseases in the elderly, as well as healthy lifestyles for the elderly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global cognitive function	The Chinese version of Montreal Cognitive Assessment will be used to assess the global cognitive function.The scale has a total score of 30 points, encompassing eight assessment sections: visual-spatial and executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. It involves multiple cognitive domains. A higher score indicates better cognitive functioning.	Baseline (pre-intervention), six-month follow-up (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory	The Chinese version of Auditory Verbal Learning Test will be used to assess the memory. This includes immediate memory, short-term memory, long-term memory, and recognition memory. A higher score indicates better memory performance.	Baseline (pre-intervention), six-month follow-up (post-intervention)
Verbal fluency	The Chinese version of Verbal Fluency Test will be used to assess the verbal fluency. A higher score indicates better verbal language performance.	Baseline (pre-intervention), six-month follow-up (post-intervention)
Naming difficulty	The Chinese version of Boston Naming Test will be used to assess the naming difficulty. The total scores range from 0 to 30, a higher score indicates better language functioning.	Baseline (pre-intervention), six-month follow-up (post-intervention)
Executive function	The Chinese version of Shape Trail Test will be used to assess the execuite function. The shorter the usage time indicates better executive functioning.	Baseline (pre-intervention), six-month follow-up (post-intervention)
Visuospatial skills	The Chinese version of Rey-Osterrieth Complex Figure Test will be used to assess the visuospatial skills. A higher score indicates better visual-spatial structural abilities.	Baseline (pre-intervention), six-month follow-up (post-intervention)
Health-Promoting Lifestyle	The Chinese version of Health-Promoting Lifestyle Profile-II will be used to assess the health lifestyle . The total score range from 40 to 160. A higher score indicates better health lifestyle.	Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Abilities for health practices	The Chinese version of self-rated abilities for health practices scale will be used to assess the ability of health practice. The total score range from 0 to 112. A higher score indicates higher self-efficacy in healthy behaviors.	Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Lonliness	The University of California at Los Angels Loneliness scale will be used to assess the loneliness. A higher score indicates more lonliness.	Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Social network	The Lubben Social Network Scale will be used to assess the social network. The lower score indicates lower risk of social isolation.	Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Depression	The Geriatric Depression Scale will be used to assess the depression. The Cronbach coefficient of this scale is 0.93.	Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Self-efficacy	The Chinese version of Self-efficacy Scale will be used to assess the self-efficacy. The total score range from 10 to 40.	Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Self-esteem	The Self-esteem Scale will be used to assess the self-esteem. A higher score indicates higher level of Self-esteem.	Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Sleep quality	The Athens Insomnia Scale will be used to assess the sleep quality.The Cronbach coefficient of this scale is 0.89, highest score is 24.	Baseline (pre-intervention), six-month follow-up (post-intervention)
Subjective cognitive function	The Subjective Cognitive Decline Questionnaire 9 will be used to assess the subjective cognitive function. The Cronbach coefficient of this scale is 0.88, highest score is 9.	Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Quality of life of Alzheimer's disease	The Quality of life-Alzheimer's disease scale will be used the quality of life. A higher score indicates better quality of life. The highest score is 39 points.	Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Anxiety	The Self-rating Anxiety Scale will be used to assess the anxiety. The subjects will fill in the form based on their own situation in the past week.	Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)

Collaborators and Investigators

• Sponsor: Fujian Provincial Hospital
• Investigators: Study Director: Yuanjiao Yan, PhD, Shengli clinical medical college of Fujian Medical university

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction
• Other Study ID Numbers: K2024-04-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Research data and research-related materials will be available in a repository or online. After completion of the study, relevant data will be provided in the form of a universal resource locator or digital object identifier.
• IPD Sharing Time Frame: After completion of the study, relevant data will be provided in the form of a universal resource locator or digital object identifier.
• IPD Sharing Access Criteria: Researchers whose proposed use of the data has been approved
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No