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Frailty SyndromeMV-FITNCT05962203

SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania

A study testing Multi-factorial geriatric assessment, monitoring & management systems in people with Frailty Syndrome, run by University Medicine Greifswald.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Frailty Syndrome
What is being tested?
Multi-factorial geriatric assessment, monitoring & management systems
Could I receive a placebo?
No, everyone receives an active treatment
How many people
820 participants
Where
No sites listed yet
Study dates
1 Sep 2023to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • age 65 years or older
  • mGFR > 30 mL/min per 1.73 m2
  • being able to understand and give written informed consent.

Who cannot join

  • bedridden
  • palliative
  • inability to consent
  • severe dementia
  • inability to speak
  • lack of compliance (paracusis, inability to fulfill at least 60% of the assessments)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Maik Gollasch, MD, PhD contact

+493836257594

maik.gollasch@med.uni-greifswald.de

Julia Rüdebusch, PhD contact

+49 (0) 3834-86-7423

julia.ruedebusch@uni-greifswald.de

About this study

Official title: SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania.

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.

Read the 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.

Being tested
Multi-factorial geriatric assessment, monitoring & management systems
Keywords
Chronic kidney disease, Frailty, Falls, Cognitive decline, Multi-component interventions, Rural communities
Medical subject headings
Frailty, Renal Insufficiency, Chronic, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-factorial geriatric assessment, monitoring & management systemsDiagnostic test

    Also called Community-based and home-based exercise programs

    Multi-factorial geriatric assessment, monitoring \& management systems, e.g. community-based and home-based exercise programs, polypharmacy

Study groups in NCT05962203
Study groupRoleWhat they receive
Multi-factorial geriatric assessment, monitoring & management systemsExperimentalAll participants in the observational/interventional study (MV-FIT) will receive guideline-based, multi-factorial geriatric assessment, monitoring \& managements (multi-component healthcare). Other: GFR Measuremments, Blood sampling, Urine sampling
Receives: Diagnostic Test: Multi-factorial geriatric assessment, monitoring & management systems

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frailty

    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.

    Measured: from baseline to follow-up at 36 month

  2. body weight loss

    unintentional body weight loss (determined weight in kilograms); see phenotype criteria (# 1) above

    Measured: 36 months

  3. slow walking pace

    slow walking pace (determined by walking speed measurements in m/sec); see phenotype criteria (# 2) above

    Measured: 36 months

  4. exhaustion

    self-reported exhaustion (determined by questionnaire), see phenotype criteria (# 3) above

    Measured: 36 months

  5. muscle weakness

    muscle weakness (determined by handgrip and jump strengths in kg); see phenotype criteria (# 4) above

    Measured: 36 months

  6. low physical activity

    (5) self-reported low physical activity (determinded by questionnaire); see phenotype criteria (# 5) above

    Measured: 36 months

Secondary outcomes (9)

  1. Frailty transition

    Frailty transition (pre-frailty, in which one or two criteria (see above) are present)

    Measured: 36 months

  2. mGFR transition

    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)

    Measured: 36 months

  3. patient welfare

    self-reported patient welfare (questionnaire)

    Measured: 36 months

  4. ability to live independently

    self-reported ability to live independently (Barthel Index for Activities of Daily Living (ADL))

    Measured: 36 months

  5. cognitive decline

    cognitive decline

    Measured: 36 months

  6. number of falls

    self-reported number of falls

    Measured: 36 months

  7. admission to hospitals

    self-reported admission to hospitals

    Measured: 36 months

  8. referrals to nursing homes

    self-reported referrals to nursing homes

    Measured: 36 months

  9. mortality

    all-cause mortality in primary care

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start1 Sep 2023 (estimated)
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Multivariable logistic regression; Multivariable Cox regression, Chi-Square-Test, Propensity score matching
Masking
None (open label)
Enrolment
820 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05962203
Sponsor's protocol ID
BB 161/22
Acronym
MV-FIT
Status last verified
Jul 2023
First submitted
13 Jun 2023
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multi-factorial geriatric assessment, monitoring & management systems in people with Frailty Syndrome, run by University Medicine Greifswald.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maik Gollasch, MD, PhD (+493836257594, maik.gollasch@med.uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frailty (time frame: from baseline to follow-up at 36 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05962203.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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