Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-06-13
Brief Title:
SHIP-AGE Frailty Renal Function and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania
Sponsor:
University Medicine Greifswald
Organization:
University Medicine Greifswald
Study Overview
Official Title:
SHIP-AGE Frailty Renal Function and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MV-FIT
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 SHIPSHIP 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 observationalinterventional investigation MV-FIT is an observational study of individuals aged 65 years or older with mGFR 30 mLmin n820 All participants in the observationalinterventional 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 SHIPSHIP-TREND data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None