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Trajectory of Frailty and Cognitive Dysfunction in Older Adults

Study of the Joint Trajectory of Frailty and Cognitive Dysfunction Among Community-dwelling Older Adults

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06276166
Enrollment
934
Registered
2024-02-23
Start date
2024-03-15
Completion date
2026-12-31
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction, Community-dwelling Older Adults, Frailty

Brief summary

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

Detailed description

According to the inclusion and exclusion criteria, the older adults will be selected from community health service centers in four districts of Beijing. Frailty and cognitive function of the older adults will be assessed for a 24-month longitudinal multi-time (baseline, 6, 12 and 24 months). The heterogeneity of the development trend of frailty and cognitive function will be explored, and the subgroups of joint development trajectory of frailty and cognitive impairment will be classified, so as to identify high-risk populations that need to be managed.

Interventions

OTHERNo intervention

No intervention

Sponsors

Zheng Li
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
FrailtyBaseline, 6 month, 12 month, and 24 monthFrailty 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.
Cognitive functionBaseline, 6 month, 12 month, and 24 monthThe 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.

Other

MeasureTime frameDescription
AnxietyBaseline, 6 month, 12 month, and 24 monthGeneral 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.
ApathyBaseline, 6 month, 12 month, and 24 monthThe 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?.
Health status and life styleBaseline, 6 month, 12 month, and 24 monthData on health status (disease, hearing) and lifestyle (diet, sleep, exercise) of the elderly were obtained through self-made questionnaires.
Social networkBaseline, 6 month, 12 month, and 24 monthLubben Social Network Scale (LSNS-6) includes a set of three items on family and a comparable set of three items on friends, asking about frequency of contact and emotional closeness. More specifically, the items address the number of network members whom the respondent (a) sees or hears from at least once a month, (b) feels at ease talking about private matters, and (c) feels close enough to call for help. The respondent answered each question by selecting a value on a 6-point scale (ranging from 0 = none to 5 = nine or more). Each family/friend subscale could range from 0 to 15, and the total score from 0 to 30. Higher scores indicate stronger ties with family or friends.
Perceived social supportBaseline, 6 month, 12 month, and 24 monthThe perceived social support scale (PSSS) consists of 12 items, which are divided into three dimensions: family support, friends support and other support. The scale was developed by Zimet et al. and has a favourable internal consistency (Cronbach's α = 0.85-0.91). Each item is scored from 1 (strongly disagree) to 7 (strongly agree), and the total score ranges from 7 to 84. The higher the score is, the higher the level of social support the individual feels.
Activities of daily life (ADLs)Baseline, 6 month, 12 month, and 24 monthThe 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.

Contacts

Primary ContactZheng Li
zhengli@pumc.edu.cn13701257650

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026