Clinical trial NCT06442943: Impact of the Digital Multi-domain Cognitive Intervention in High-risk Populations for Dementia
Official title: Impact of the Digital Multi-domain Cognitive Intervention in High-risk Populations for Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Dysfunction
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 128
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Global cognitive function
timeFrame: Baseline (pre-intervention), six-month follow-up (post-intervention)
Secondary outcomes:
measure: Memory
timeFrame: Baseline (pre-intervention), six-month follow-up (post-intervention)
measure: Verbal fluency
timeFrame: Baseline (pre-intervention), six-month follow-up (post-intervention)
measure: Naming difficulty
timeFrame: Baseline (pre-intervention), six-month follow-up (post-intervention)
measure: Executive function
timeFrame: Baseline (pre-intervention), six-month follow-up (post-intervention)
measure: Visuospatial skills
timeFrame: Baseline (pre-intervention), six-month follow-up (post-intervention)
measure: Health-Promoting Lifestyle
timeFrame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
measure: Abilities for health practices
timeFrame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
measure: Lonliness
timeFrame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
measure: Social network
timeFrame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
measure: Quality of life of Alzheimer's disease
timeFrame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
measure: Anxiety
timeFrame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
measure: Depression
timeFrame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
measure: Self-efficacy
timeFrame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
measure: Self-esteem
timeFrame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
measure: Sleep quality
timeFrame: Baseline (pre-intervention), six-month follow-up (post-intervention)
measure: Subjective cognitive function
timeFrame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
affiliation: Shengli clinical medical college of Fujian Medical university
name: Yuanjiao Yan, PhD
role: STUDY_DIRECTOR
References: