Community health service centers
Ya'an, Sichuan, 610065, China
Location status: Recruiting
NCT Number: NCT06836440
The aim of this project is to explore whether vision correction can effectively slow cognitive decline in older adults.
The primary question it seeks to answer is: Can providing free near and/or distance vision correction glasses to older adults with refractive errors or uncorrected vision, who have normal baseline cognition and hearing, reduce the rate of cognitive decline over 36 months in a cost-effective manner? Researchers will compare the rate of cognitive decline over 36 months between older adults who receive refractive correction and those who do not.
Interested in participating?
Request Info60 year–79 year
All sexes
Interventional
Not applicable
Ya'an, Sichuan, 610065, China
Location status: Recruiting
Exploratory subgroup analyses will be conducted to assess whether the intervention effect on cognitive decline differs according to baseline vision correction needs (near vision correction, distance vision correction, or both) and baseline cognitive function. These analyses will be interpreted cautiously due to their exploratory nature.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants can choose from a variety of frames, and the research team will customize the glasses according to their pupillary distance and prescription. Once the glasses are ready, they will be provided to the participants following standard usage instructions. In case of loss or damage, participants should report it to the project team and will be provided with replacement glasses as needed. Each year, participants in the intervention group will undergo an eye exam to assess changes in vision, and their glasses prescription will be updated if necessary.
Time frame: Baseline to 12, 24, and 36 months
The primary outcome will be the change in global cognitive function from baseline to the 36-month follow-up, assessed by the total score of the Chinese version of the Montreal Cognitive Assessment Basic (MoCA-BC) . The MoCA-BC was selected because it minimizes reading and writing requirements and has been widely used in China, allowing for reliable cognitive assessment among individuals who are illiterate or have limited formal education.
Time frame: Baseline to 12, 24, and 36 months
Secondary outcomes include domain-specific cognitive performance derived from a composite cognitive battery based on the China Health and Retirement Longitudinal Study (CHARLS) cognitive assessments. The CHARLS-based cognitive battery comprises a set of task-based cognitive assessments, such as measures of orientation, episodic memory, verbal fluency, and executive function. These tasks rely primarily on oral responses, making them particularly suitable for participants with uncorrected refractive errors, for whom visually demanding tasks may be challenging.
Time frame: Baseline to 12, 24, and 36 months
Falls risk will be assessed using the prespecified falls-risk assessment included in the study protocol.
Time frame: Baseline to 12, 24, and 36 months
Vision-related quality of life will be assessed using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25).
Time frame: Baseline to 12, 24, and 36 months
Health-related quality of life will be assessed using the EQ-5D-5L.
Time frame: Baseline to 12, 24, and 36 months
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9).
Time frame: Baseline to 12, 24, and 36 months
Physical activity will be assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF)
Time frame: Baseline to 12, 24, and 36 months
Social network will be assessed using the Lubben Social Network Scale-6 (LSNS-6)
Time frame: From baseline through 36 months
Cost-effectiveness will be expressed as the incremental cost per quality-adjusted life year (QALY) gained in the intervention group compared with the control group. Costs will include healthcare service utilization and associated costs assessed using CSRI-adapted items and productivity-related information collected using the WPAI. QALYs will be derived from EQ-5D-5L utility scores.
Interested in participating?
Request InfoYuju Wu
Other
The Impact of Spectacle Intervention for Refractive Error and Presbyopia on Cognitive Function in Rural Older Adults
Acronym: CLEVER
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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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