Applied Research on a Non-pharmacological Intervention Program for Older Adults With Subjective Cognitive Decline

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorChina Medical University, China

About this trial

This study aims to verify the short-term and long-term effects of a group-based non-pharmacological intervention program for community-dwelling older adults with subjective cognitive decline, and to evaluate its implementation outcomes, through a rigorously designed cluster randomized controlled trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • non-pharmacological interventions

    Other intervention

    6 components(social intercourse, cognitive interventions, physical activities interventions, rational diet, understanding and risk management of diseases, emotion management)

  • Waiting List

    Other intervention

    To ensure ethical fairness, the same intervention program will subsequently be provided to the waitlist control group after positive effects are confirmed in the intervention group.

Treatment groups

218 Participants
are divided into 2 treatment groups
Group A: Non-Pharmacological InterventionsExperimental treatment 1 intervention
Group B: Waiting List Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Episodic memory

Using the Huashan version of the Auditory Verbal Learning Test (AVLT) for assessment, it is mainly used to evaluate immediate recall, short-delay recall, long-delay recall, and other key components. The test includes 12 words belonging to three semantic categories (4 words per category). The testing procedure is as follows: The examiner reads out the 12 words in sequence, and the subject immediately recalls them. This process is repeated three consecutive times to form the immediate memory test. After an interval of 5 minutes, short-delay recall is conducted, and after 20 minutes, long-delay recall is implemented. The scoring rule is that each correctly recalled word earns 1 point. The immediate memory score is the sum of correct recalls from the first three trials (maximum score 36). This study records the scores for immediate recall, short-delay recall, and long-delay recall, with higher scores indicating better memory function.

Time frame
week0,week12,week24
2

Gobal cognitive function

The assessment uses the Montreal Cognitive Assessment (MoCA). Higher scores indicate better performance, with a minimum score of 0 and a maximum score of 30.

Time frame
week0,week12,week24
3

Executive function

The Shape Trail Test (STT) was used to assess executive function. The test consists of two parts: Part A requires participants to connect 25 numbers in ascending order; Part B involves 25 numbers presented within two different shapes. The scoring indicators are the time taken to complete STT-A and STT-B, with shorter completion times indicating better executive function.

Time frame
week0,week12,week24
4

Attention

The Digit Symbol Substitution Test (DSST) is used to assess the patient's attention. The subject is required to match the corresponding symbols to the numbers (1-9) as quickly as possible within 90 seconds. Each correctly filled symbol earns 1 point, and a reversed symbol earns 0.5 points. The maximum score for the test is 90.

Time frame
week0,week12,week24

Secondary outcomes

1

Depression

The short version of the Geriatric Depression Scale (Geriatric Depression Scale-15, GDS-15) is used for assessment. The total score ranges from 0 to 15, and the score is positively correlated with the severity of depression.

Time frame
week0,weel12,week24
2

Anxiety

The Geriatric Anxiety Inventory-20 (GAI-20) is used for assessment. This scale consists of 20 items, and respondents answer based on their emotional feelings over the past week. A response of "Yes" is scored as 1 point, while "No" is scored as 0 points. The total score ranges from 0 to 20, with higher scores indicating more severe anxiety.

Time frame
week0,week12,week24
3

Social network

The Lubben Social Network Scale-6 (LSNS-6) is a short version of the Lubben Social Network Scale. It is primarily used to measure an individual's level of social connectedness in two dimensions: family relationships and peer interactions. The scale consists of six assessment items and uses a graded scoring system: 0 points indicate no such social members, 1 point corresponds to 1 person, 2 points to 2 people, 3 points to 3-4 people, 4 points to 5-8 people, and 5 points applies to groups of 9 or more individuals. Lower scores indicate poorer levels of social network connectedness.

Time frame
week0,week12,week24
4

Social participation

This study employed the Social Participation Level Assessment Tool revised by Wei Xiuping, which was developed based on national health survey data of the elderly population. The measurement tool comprises two main dimensions: cultural organization participation and family/personal affairs, encompassing a total of 10 specific items. A five-point Likert scale was used for measurement, and the total score is positively correlated with the level of social participation-that is, a higher score indicates a more significant degree of social participation among the respondents.

Time frame
week0,week12,week24

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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