Community-based Cohort of Functional Decline in Subjective Cognitive Complaint Elderly
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- STATUS
- Recruiting
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- participants needed
- 300
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- sponsor
- Geroscience Center for Brain Health and Metabolism (Gero)
Summary
Background With the global population aging and life expectancy increasing,
Objective This study has two main objectives. First, i) to analyze the rate of functional
decline and progression to clinical
Methods The Gero cohort aims at recruiting 300 elderly subjects (>70 years) from the community of Santiago (Chile), following them up for at least 3 years. Eligible people are non-demented adults with subjective cognitive complaint, which are reported either by the participant, the proxy or both. Participants are identified through a household census. The protocol of evaluation is based on a multidimensional approach including socio-demographic, biomedical, psychosocial, neuropsychological, neuropsychiatric and motor assessments. Neuroimaging, blood and stool sample samples are also included. This multidimensional evaluation is carried out in a baseline assessment and 3 follow-ups assessment, at 18 and 36 months. In addition, in months 6, 24, and 30, a telephone interview is done in order to keep contact with the participants and to assess general well-being.
Description
Objectives of the Study:
The general objective of this study is to analyze the rate of functional decline (FD) and
progression to clinical
The Gero cohort is the core clinical project of the GERO, supported by the Fund for Research Centers in Priority Areas Program (FONDAP) of the Chilean National Commission for Scientific and Technological Research (CONICYT). GERO is initially funded for 5 years, and its main aim is to establish a center for studying Brain Aging in Chile including basic and clinical research.
Methods/Design
Field work during the first contact
The recruitment process considers two steps. Firstly, a lay team contacts each home to determine the presence of eligible individuals. In positive cases, the person receives a second visit by a trained psychologist who proceeds to check the eligibility. In case of acceptance, the inclusion and exclusion criteria protocol are applied. If the subject fulfills the criteria, the psychologist schedule a medical interview. Following this evaluation, a neurologist decides if the subject fulfill the inclusion criteria of the cohort.
The fieldwork is preceded by an outreach campaign (flyers, local radio advertisements, and presentations to community-organized groups) raising awareness about the visit of interviewers and the relevance of participating in the study. Rates of contact and response are monitored permanently, and the procedures around the contact and first interview are checked in the field and also by telephone to a subsample of participants. Contact to homes is attempted up to three times on different days and hours before considering it frustrated. The fieldwork started in November 2017 and is expected to finish at the end of 2019.
The lay team and psychologists involved in the first contact and recruitment received
specific training on their labour in the field. The lay team completed a whole week training,
which included theoretical and practical elements. Psychologists received a twelve weeks
length training, which covers several sessions of
Sample size
The sample size had to satisfy two criteria, one concerned with the statistical power
required to explore multiple associations with outcomes, and other related to the feasibility
to perform a wide range of assessments to each participant assuming costs and logistics. Both
criteria meant a trade-off between the
Follow-up and retention strategy
Socio-demographic, clinical, psychosocial, neuropsychological, neuropsychiatric, motor, neuroimaging, blood biomarkers, stool, and genetic samples will be performed as baseline evaluation and every 18 months, with the exception of genetic study that will be performed only at baseline and neuroimaging at baseline and the 36 month. Patients' health status, functionality, and involvement in the Gero cohort will be monitored every 6 months by a telephonic questionnaire.
To avoid a significant
Assessments and measurements
The protocol considers an intensive and deep multidimensional study of factors related to the
prognosis of FD and
Data analysis plan
The Gero cohort offers a unique opportunity for multiple analyses to identify, correlate and
analyze multidimensional factors related to FD and progression to
In broad terms, a descriptive of baseline measurements (either outcomes or potential predictive factors) will be performed. The procedure will be repeated at each measurement time, every 18 months. Random effect models will be used for describing trajectories of participant subgroups and the whole cohort according to main variables, using Markov-Chain Montecarlo procedures.
The association between variables and outcomes will be explored broadly using different machine learning methods, such as elastic net procedure, random forest procedure, based-tree methods, and support vector machines. These procedures are suitable to lead with multi-collinearity and also high dimensional data (e.g. the number of predictive variables is larger than the number of participants in the cohort). Interpretation of causality will be conducted using standard random effect models and eventually structural equation modeling.
Missing data and loss of follow up of participants are common in observational studies, mainly in cohorts. Firstly, cases with missing data in any outcome will be explored and compared with cases without missing data describing any pattern. Secondly, two strategies will be followed to estimate results: (1) to analyze only cases with complete information (i.e. assuming that missing data is completely at random); and (2) imputing data according to multivariate imputation by chained equation techniques. The analysis will be performed using the statistical software R.
Coordination with local health services
The Gero cohort has been carefully design to avoid undermining the usual care of participants in their common health services facilities. Even more, a linkage between the health assessments provided by the cohort and the usual health care has been promoted.
In cases when the cohort's assessment detects a new health condition (
Primary care health centres, specialized care polyclinics and the direction of the Health District involved have been informed about the study and jointly the protocol of derivation and communication were established.
Regulation of access to data/biospecimens
The access to data and biospecimens is regulated by the GERO directorate in accordance with the local Institutional Review Board authorization. A bilateral agreement must be signed before sharing of data. Access to the server will not be granted.
Details
Condition |
Spastic gait, |
---|---|
Age | 70years - 100years |
Clinical Study Identifier | NCT04265482 |
Sponsor | Geroscience Center for Brain Health and Metabolism (Gero) |
Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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