Trajectory of Frailty and Cognitive Dysfunction in Older Adults

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorZheng Li

About this trial

To explore the heterogeneity of the development trend of frailty and cognitive function of older adults.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥60 years.

Older adults with clear consciousness, ability of simple written and verbal communication.

They volunteered to participate in this study, and signed an informed consent.

Disqualifiers

A clear diagnosis of any type of dementia.

There are neurological diseases that clearly lead to cognitive dysfunction, such as severe cerebrovascular disease, brain trauma, intracranial tumors, etc.

They have been clearly diagnosed with mental disorders affecting cognitive function, including schizophrenia, depression, bipolar disorder, etc.

Trial population

Older adults without clear diagnosis of any type of dementia, neurological diseases, and mental disorders that affecting cognitive function.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

934 Participants
are divided into 1 treatment group
Group A: Older adults1 intervention

Trial outcomes

Primary outcomes

1

Frailty

Frailty was evaluated by the Fried phenotype model, which was proposed and validated by Fried and colleagues, and is the most widely adopted model, generally regarded as the standard model for physical frailty. In Fried's model, the frailty phenotype is based on the following five components: slowness (gait speed), weakness (hand grip), weight loss, exhaustion, and low physical activity.

Time frame
Baseline, 6 month, 12 month, and 24 month
2

Cognitive function

The method to assess objective cognitive function is Montreal Cognitive Assessment-Beijing version for Chinese, which is a classical tool to screen for MCI, including 7 cognitive domains (visuospatial and executive function, naming, attention, language, abstraction, delayed recall, and orientation). The total score of the scale is 30, with higher scores indicating better cognitive function. The Mini-Mental State Examination (MMSE) which included 30 questions to measure the cognitive status will be also performed to assess objective cognitive function. In addition, We use the 9-items subjective cognitive decline questionnaire (SCD-Q9) to measure the symptoms of subjective cognition. The SCD-Q9 is a simple and quick screening scale to identify those who suffer from MCI from general populations. SCD-Q9 lists the 9 core items of SCD symptoms and contains 2 dimensions and 9 items.

Time frame
Baseline, 6 month, 12 month, and 24 month

Secondary outcomes

Other outcomes

1

Health status and life style

Data on health status (disease, hearing) and lifestyle (diet, sleep, exercise) of the elderly were obtained through self-made questionnaires.

Time frame
Baseline, 6 month, 12 month, and 24 month
2

Activities of daily life (ADLs)

The Chinese version of the ADLs scale revised by Zhang will be utilized to identify the ability to perform the activities. A summary score for each item ranges from 1 (require no help) to 4 (unable to do it at all) points. The first eight items measure Basic Activities of Daily Living (BADLs), with a total score of 8\~32. The last 12 items are about Instrumental Activities of Daily Living (IADLs), with a total score of 12\~48. The lower the score, the lower the degree of dependence on daily life.

Time frame
Baseline, 6 month, 12 month, and 24 month
3

Anxiety

General anxiety disorder-7 (GAD-7) will be utilized, which is a seven-question screening tool that identifies whether a complete assessment for anxiety is indicated. Scoring Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

Time frame
Baseline, 6 month, 12 month, and 24 month
4

Apathy

The apathy subscale (GDS-3A) of the GDS-15 consists of the following three items (score range 0-3 points) will be utilized: (i) Have you dropped many of your activities and interests?; (ii) Do you prefer to stay at home, rather than going out and doing new things?; and (iii) Do you feel full of energy?.

Time frame
Baseline, 6 month, 12 month, and 24 month

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zheng Li

Lead sponsor

Peking Union Medical College

Sponsor institution

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