Frailty Syndrome
Conditions
Keywords
Chronic kidney disease, Frailty, Falls, Cognitive decline, Multi-component interventions, Rural communities
Brief summary
Chronic kidney disease (CKD) is a leading risk factor for cardiovascular and all-cause mortality among the elderly. Mecklenburg-Western Pomerania has the largest prevalence of CKD in Germany and Europe. The CKD impact in primary care strategies to reduce frailty syndrome in the elderly is unknown. For this purpose, about 820 elderly participants will be included in an observational study (MV-FIT), who will undergo an multi-factorial geriatric assessment, monitoring & management program, specifically designed to avoid frailty. The goal of the full-scale study is to evaluate the impact of CKD in multi-component primary care strategies to reduce frailty among elderly persons in rural Mecklenburg-Western Pomerania. MV-FIT will be conducted on individuals in rural Mecklenburg-Western Pomerania, who will be observed over a period of 3 years. The Study of Health in Pomerania (SHIP) is a population-based epidemiological, two independent-cohort, study (SHIP and SHIP-TREND). SHIP cohorts have been followed for \>24 years. SHIP/SHIP TEND participants \>60 years or older will studied by a follow-up survey. The aim is to gain new insights into the development of frailty and to develop strategies for keeping those affected healthy.
Detailed description
Our study is a longitudinal population-based epidemiological SHIP-cohort study combined with a prospective, multi-centered, observational/interventional investigation. MV-FIT is an observational study of individuals aged 65 years or older with mGFR \>30 mL/min (n=\ 820). All participants in the observational/interventional study will receive guideline-based, multi-factorial geriatric assessment, monitoring & managements (multi-component healthcare). Subjects will be stratified by mGFR. Objectives are 1) to implement multi-component healthcare specifically comprised of components to reduce frailty and incident falls, 2) to improve compliance and adherence to the multi-component healthcare for frailty and improvement of patient welfare, ability to live independently, quality-of-life, number of falls, referrals to nursing homes, all-cause mortality in primary care of the elderly, 3) to seek the elderly individuals' experience during the course of multi-factorial primary care intervention through In-depth interviews, 4) to clarify the burden of CKD on frailty and health status, and 5) to identify novel risk factors and mechanisms for frailty and pre-frailty. MV-FIT data will be corroborated by SHIP/SHIP-TREND data.
Interventions
DIAGNOSTIC_TESTMulti-factorial geriatric assessment, monitoring & management systems
Multi-factorial geriatric assessment, monitoring & management systems, e.g. community-based and home-based exercise programs, polypharmacy
Sponsors
University Medicine Greifswald
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Multivariable logistic regression; Multivariable Cox regression, Chi-Square-Test, Propensity score matching
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* age 65 years or older * mGFR \> 30 mL/min per 1.73 m2 * being able to understand and give written informed consent.
Exclusion criteria
* bedridden * palliative * inability to consent * severe dementia * inability to speak * lack of compliance (paracusis, inability to fulfill at least 60% of the assessments)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frailty | from baseline to follow-up at 36 month | The primary outcome will be frailty from baseline to follow-up at 36 months post subject inclusion (i.e. Frail vs. non-Frail). The frailty phenotype defines frailty as a clinical syndrome meeting three or more of five phenotypic criteria: (1) unintentional body weight loss (2) slow walking pace, (3) self-reported exhaustion, (4) muscle weakness, and (5) self-reported low physical activity. |
| body weight loss | 36 months | unintentional body weight loss (determined weight in kilograms); see phenotype criteria (# 1) above |
| slow walking pace | 36 months | slow walking pace (determined by walking speed measurements in m/sec); see phenotype criteria (# 2) above |
| exhaustion | 36 months | self-reported exhaustion (determined by questionnaire), see phenotype criteria (# 3) above |
| muscle weakness | 36 months | muscle weakness (determined by handgrip and jump strengths in kg); see phenotype criteria (# 4) above |
| low physical activity | 36 months | (5) self-reported low physical activity (determinded by questionnaire); see phenotype criteria (# 5) above |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| admission to hospitals | 36 months | self-reported admission to hospitals |
| Frailty transition | 36 months | Frailty transition (pre-frailty, in which one or two criteria (see above) are present) |
| mortality | 36 months | all-cause mortality in primary care |
| referrals to nursing homes | 36 months | self-reported referrals to nursing homes |
| mGFR transition | 36 months | mGFR transition (transition from GFR KDIGO (Kidney Disease: Improving Global Outcomes) Stage 2 CKD in mL/min per 1.73 m2 to KDIGO Stage 3 in mL/min per 1.73 m2) |
| patient welfare | 36 months | self-reported patient welfare (questionnaire) |
| ability to live independently | 36 months | self-reported ability to live independently (Barthel Index for Activities of Daily Living (ADL)) |
| cognitive decline | 36 months | cognitive decline |
| number of falls | 36 months | self-reported number of falls |
Contacts
Primary ContactMaik Gollasch, MD, PhD
Backup ContactJulia Rüdebusch, PhD
Outcome results
None listed