NCT03342976

Brief Summary

This is a multicenter, multicultural, randomized control trial. Participants will be recruited from 10 centers located in Italy, Germany, Austria, Spain, United Kingdom, Belgium, Sweden, Japan, South Korea and Australia. The main objective of the study is to examine the efficacy of a sensor-based platform (my-AHA platform) to assess frailty risks and to deliver tailored interventions in order to prevent in elderly subjects conversion from a pre-frail status to a frailty status.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

May 3, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2.5 years

First QC Date

October 22, 2017

Last Update Submit

November 29, 2023

Conditions

Frail Elderly SyndromeCognitive ImpairmentPhysical Dependence

Keywords

FrailtyPhysical impairmentCognitive declineICT

Outcome Measures

Primary Outcomes (1)

  • Conversion rate from a pre-frail status to a frail status (Fried criteria)

    Comparison of conversion rate in cases and controls between pre-frail status fo frail status

    18 months

Study Arms (2)

Cases

ACTIVE COMPARATOR

Pre-frail subjects will use an ICT platform (my-AHA platform) embedded in a mobile phone and a fit-band that will continuously monitor physical and cognitive activities. Interventions regarding physical, cognitive, psychological and social domains will be prescribed and monitored through the my-AHA platform. In addition, sleep and dietary habits will be investigated and tailored interventions will be suggested.

Other: My-AHA platform

Controls

PLACEBO COMPARATOR

Pre-frail subjects will be followed according to "best standard of care" protocols. Interventions regarding physical, cognitive, psychological and social domains will be prescribed. In addition, sleep and dietary habits will be investigated and tailored interventions will be suggested.

Other: My-AHA platform

Interventions

My-AHA platformOTHER

ICT strategy for early detection of frailties

CasesControls

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: over 60 yrs
  • Able to stand and walk unassisted
  • Free of significant cognitive impairment (age-corrected Mini Mental State Examination Test ≥ 24)
  • Free of clinically significant mood disturbance (HADS-Anxiety \<15; HADS-depression \< 15)
  • Free of any acute or unstable medical conditions
  • Able to understand directions and participate in the protocol
  • Able to sign informed consent
  • Subjects will be enrolled in the study if they meet one or two of the Fried et al. (2001) criteria for Frailty (Pre-Frailty status).
  • \. Shrinking, evidenced by weight loss (unintentional) ≥ 4.5 kg unintentional in prior 12 months; or at follow-up assessment ≥ 5% of body weight in prior 12 months.
  • , Weakness. Grip strength in lowest 20% at baseline adjusted for gender and BMI.
  • \. Poor endurance and energy. Self-report of exhaustion as indicated by responses to 2 questions on Center for Epidemiologic Studies Depression (CES-D) scale.
  • \. Slowness .Time to walk 15ft (4.57m) ≤ slowest 20% adjusted for gender and standing height.
  • \. Low physical activity level. Lowest quintile (25%) by gender for weighted kcal expenditure per week at baseline.

You may not qualify if:

  • Participant excluded if meets 1 or more of below:
  • Mobility problems
  • cannot stand and ambulate unassisted
  • painful arthritis, spinal stenosis, amputation, or painful foot lesions that limits balance and mobility,
  • Concurrent chronic disease independently contributing to frailty
  • suffers from a significant neurodegenerative disorder, e.g.
  • Alzheimer's disease
  • Lewy body dementia
  • Frontotemporal Lobar Degeneration, Fronto-Temporal Dementia
  • Parkinson's disease
  • multiple sclerosis
  • progressive supranuclear palsy
  • amyotrophic lateral sclerosis
  • hydrocephalus
  • Huntington's disease
  • +37 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aging Brain and Memory Clinic, Department of Neuroscience, University of Torino

Torino, 10126, Italy

Location

Related Publications (5)

  • Choi J, Ahn A, Kim S, Won CW. Global Prevalence of Physical Frailty by Fried's Criteria in Community-Dwelling Elderly With National Population-Based Surveys. J Am Med Dir Assoc. 2015 Jul 1;16(7):548-50. doi: 10.1016/j.jamda.2015.02.004. Epub 2015 Mar 14.

    PMID: 25783624BACKGROUND

  • Kojima G, Taniguchi Y, Iliffe S, Walters K. Frailty as a Predictor of Alzheimer Disease, Vascular Dementia, and All Dementia Among Community-Dwelling Older People: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2016 Oct 1;17(10):881-8. doi: 10.1016/j.jamda.2016.05.013. Epub 2016 Jun 17.

    PMID: 27324809BACKGROUND

  • Shamliyan T, Talley KM, Ramakrishnan R, Kane RL. Association of frailty with survival: a systematic literature review. Ageing Res Rev. 2013 Mar;12(2):719-36. doi: 10.1016/j.arr.2012.03.001. Epub 2012 Mar 12.

    PMID: 22426304BACKGROUND

  • Panza F, Solfrizzi V, Frisardi V, Maggi S, Sancarlo D, Adante F, D'Onofrio G, Seripa D, Pilotto A. Different models of frailty in predementia and dementia syndromes. J Nutr Health Aging. 2011 Aug;15(8):711-9. doi: 10.1007/s12603-011-0126-1.

    PMID: 21968870BACKGROUND

  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PMID: 11253156BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionFrailty

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Georg Aumayr, PhD

    Johanniter International

    PRINCIPAL INVESTIGATOR

  • Helios De Rosario, PhD

    IBV-Gesmed, Spain

    PRINCIPAL INVESTIGATOR

  • Mathew Summers, PhD

    Sunshine Coast University, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

October 22, 2017

First Posted

November 17, 2017

Study Start

May 3, 2018

Primary Completion

October 30, 2020

Study Completion

December 31, 2020

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)