- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06276166
Trajectory of Frailty and Cognitive Dysfunction in Older Adults
Study of the Joint Trajectory of Frailty and Cognitive Dysfunction Among Community-dwelling Older Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zheng Li
- Phone Number: 13701257650
- Email: zhengli@pumc.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Older adults
Older adults without clear diagnosis of any type of dementia, neurological diseases, and mental disorders that affecting cognitive function.
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frailty
Time Frame: Baseline, 6 month, 12 month, and 24 month
|
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.
|
Baseline, 6 month, 12 month, and 24 month
|
Cognitive function
Time Frame: Baseline, 6 month, 12 month, and 24 month
|
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. |
Baseline, 6 month, 12 month, and 24 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activities of daily life (ADLs)
Time Frame: Baseline, 6 month, 12 month, and 24 month
|
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.
|
Baseline, 6 month, 12 month, and 24 month
|
Anxiety
Time Frame: Baseline, 6 month, 12 month, and 24 month
|
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.
|
Baseline, 6 month, 12 month, and 24 month
|
Apathy
Time Frame: Baseline, 6 month, 12 month, and 24 month
|
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?.
|
Baseline, 6 month, 12 month, and 24 month
|
Perceived social support
Time Frame: Baseline, 6 month, 12 month, and 24 month
|
The 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.
|
Baseline, 6 month, 12 month, and 24 month
|
Social network
Time Frame: Baseline, 6 month, 12 month, and 24 month
|
Lubben 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.
|
Baseline, 6 month, 12 month, and 24 month
|
Health status and life style
Time Frame: Baseline, 6 month, 12 month, and 24 month
|
Data on health status (disease, hearing) and lifestyle (diet, sleep, exercise) of the elderly were obtained through self-made questionnaires.
|
Baseline, 6 month, 12 month, and 24 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Zheng Li, Chinese Academy of Medical Sciences & Peking Union Medical College
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 72374215
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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