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NCT Number: NCT06442943

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.

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Key information

Conditions

Cognitive Dysfunction Cognition Disorders Mental Disorders Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location status: Recruiting

Location contact

yuanjiao yan, PhD

CONTACT

[email protected]

+8618120826271

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-domain Cognitive Intervention

Behavioral
  • 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.

Primary outcomes

  1. Global cognitive function

    Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)

    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.

Secondary outcomes

  1. Memory

    Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)

    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.

  2. Verbal fluency

    Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)

    The Chinese version of Verbal Fluency Test will be used to assess the verbal fluency. A higher score indicates better verbal language performance.

  3. Naming difficulty

    Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)

    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.

  4. Executive function

    Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)

    The Chinese version of Shape Trail Test will be used to assess the execuite function. The shorter the usage time indicates better executive functioning.

  5. Visuospatial skills

    Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)

    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.

  6. Health-Promoting Lifestyle

    Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)

    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.

  7. Abilities for health practices

    Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)

    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.

  8. Lonliness

    Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)

    The University of California at Los Angels Loneliness scale will be used to assess the loneliness. A higher score indicates more lonliness.

  9. Social network

    Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)

    The Lubben Social Network Scale will be used to assess the social network. The lower score indicates lower risk of social isolation.

  10. Quality of life of Alzheimer's disease

    Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)

    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.

  11. Anxiety

    Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)

    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.

  12. Depression

    Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)

    The Geriatric Depression Scale will be used to assess the depression. The Cronbach coefficient of this scale is 0.93.

  13. Self-efficacy

    Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)

    The Chinese version of Self-efficacy Scale will be used to assess the self-efficacy. The total score range from 10 to 40.

  14. Self-esteem

    Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)

    The Self-esteem Scale will be used to assess the self-esteem. A higher score indicates higher level of Self-esteem.

  15. Sleep quality

    Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)

    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.

  16. Subjective cognitive function

    Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuanjiao Yan, PhD

CONTACT

[email protected]

18120826271 ext. 86

lian fayang, MD

CONTACT

[email protected]

0591-87557768 ext. 86

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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