Frail Elderly Syndromemy-AHANCT03342976
Investigating My Active and Healthy Aging
A study testing My-AHA platform in people with Frail Elderly Syndrome and Cognitive Impairment, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome, Cognitive Impairment, Physical Dependence
- What is being tested?
- My-AHA platform
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteItaly
- Study dates
- 3 May 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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).
- 1. 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.
- 2, Weakness. Grip strength in lowest 20% at baseline adjusted for gender and BMI.
- 3. Poor endurance and energy. Self-report of exhaustion as indicated by responses to 2 questions on Center for Epidemiologic Studies Depression (CES-D) scale.
- 4. Slowness .Time to walk 15ft (4.57m) ≤ slowest 20% adjusted for gender and standing height.
- 5. Low physical activity level. Lowest quintile (25%) by gender for weighted kcal expenditure per week at baseline.
Who cannot join
- 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.
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- 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
- prion diseases
- affected by severe peripheral nervous system and/or neuromuscular disorders, e.g.
- chronic inflammatory demyelinating polyneuropathy
- myasthenia gravis
- multiple sclerosis
- polymyositis
- Concomitant injury or disease known
- clinical evidence or history of stroke (within 2 yrs) to impact independently cognitive,
- clinical evidence or history of transient ischemic attack (within 6 months) psychological or physical function
- significant head injury with associated loss of consciousness, skull fracture or persisting cognitive impairment (2 years)
- epilepsy (a single prior seizure is considered acceptable)
- if meet Diagnostic and Statistical Manual 5 (DSM-5) criteria for:
- major depressive disorder (current)
- schizophrenia or other psychotic disorders (lifetime)
- bipolar disorder (within the past 5 years
- substance (including alcohol) related disorders (within the past 2 years)
- Presence of cognitive, sensory or
- have language deficits that impair testing perceptual deficits that interfere with assessment tasks
- have significant visual impairment
- have a significant hearing loss
- Presence of other conditions or diseases that will compromise ability to undertake interventions (especially physical)
- have clinically significant cardiovascular disease, i.e:
- hospitalization for acute coronary syndrome (acute myocardial infarction or unstable, angina)
- symptoms consistent with angina pectoris, within the 12 months
- signs or symptoms of clinical heart failure within the 12 months
- evidence of uncontrolled atrial fibrillation
- a cardiac pacemaker
- preexisting or current signs or symptoms of respiratory failure, e.g.
- chronic obstructive pulmonary disease
- bronchial asthma
- lung fibrosis
- other respiratory disease
- untreated hypertension
- metastatic cancer or immunosuppressive therapy
- concurrent acute or chronic clinically significant immunologic, hepatic (such as presence of encephalopathy or ascites), or endocrine disease (not adequately treated).
- Unacceptable Test/Laboratory Values
- 1. Postural hypotension (fall in systolic blood pressure of greater than 30 mmHg or fall in diastolic blood pressure of greater than 20 mmHg on standing compared to sitting) at the time of screening. Subjects who present at the time of screening with postural hypotension yet have no known history of postural hypotension, nor underlying medical condition related to hypotension, may be rescreened
Trial locations and contacts
1 site in 1 country.
Italy1 site
Aging Brain and Memory Clinic, Department of Neuroscience, University of Torino
Torino, 10126
About this study
Official title: Evaluation of an ICT-based Platform for Early Detection and Intervention to Prevent Frailty in Older Adults
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.
Read the detailed description
In the past decade, frailty has attracted great attention of the scientific community and public health organizations as precursor and contributor of age-related diseases. Frailty is a common clinical syndrome in older adults, affecting 7-12% of the older population, and the occurrence of frailty increases with age and may exceed 45% after age 85 years. Frailty develops when age-associated degenerative processes overwhelm reserve capacity and reparative processes that maintain function of the nervous system as well as other physiologic systems. Overall, frailty consists in the vulnerability of aged population to adverse events as the result of the subtle and progressive metabolic and physical changes. Frailty confers a significantly increased risk for poor health outcomes, incident disability, hospitalization, and mortality.
In recent years there has been an emergence of information and communication technology (ICT) -based solutions to support active ageing and tackle frailty, cognitive decline and social isolation of older adults. While these ICT-based solutions are of a certain value regarding diminishing single risks (e.g. fall risk, etc.), there is still a need for a more holistic approach which aims to address all of the individual risk factors together. Also it is necessary to provide tailored interventions based on the outcomes of the risk analysis. This assessment of risk for frailty and provision of individual tailored interventions is the main objective of My-AHA project.
My-AHA solution supports active and healthy ageing by enabling early detection and minimization of risks associated with ageing. In these terms the early risk detection considers three fundamental aspects of the life of older adults: physical activity (by considering vital signs data, gait, quality of sleep and in general, physical activity, and fall risk); cognitive activity (by monitor the cognitive level, e.ge.g. in cognitive games); and, psychosocial activities (e.g. by analyzing the emotions and the quality of speech of the users). On the other hand, My-AHA will develop and implement more efficient and effective ICT-based interventions tailored to the early identified risks. The suggested social activities, as well as cognitive and physical trainings and the diet proposed to the older adults via the new platform will help the users in changing their behaviour and in reacting to the consequences of ageing.
- Being tested
- My-AHA platform
- Keywords
- Frailty, Physical impairment, Cognitive decline, ICT
- Medical subject headings
- Cognitive Dysfunction, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My-AHA platformOther
ICT strategy for early detection of frailties
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: My-AHA platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start3 May 2018
- Primary completion30 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Innocenzo Rainero, University of Turin, Italy
- Investigators
- Georg Aumayr, PhD, Principal investigator, Johanniter InternationalHelios De Rosario, PhD, Principal investigator, IBV-Gesmed, SpainMathew Summers, PhD, Principal investigator, Sunshine Coast University, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342976
- Sponsor's protocol ID
- PHC21-2015-689592
- Acronym
- my-AHA
- Status last verified
- Nov 2023
- First submitted
- 22 Oct 2017
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25783624Kojima 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.
PubMed 27324809Shamliyan 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.
PubMed 22426304Panza 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.
PubMed 21968870Fried 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.
PubMed 11253156
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an ICT-based Platform for Early Detection and Intervention to Prevent Frailty in Older Adults
- ClinicalTrials.gov ID
- NCT03342976
- Acronym / sponsor ID
- my-AHA / PHC21-2015-689592
- Keywords
- Frailty, Physical impairment, Cognitive decline, ICT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the past decade, frailty has attracted great attention of the scientific community and public health organizations as precursor and contributor of age-related diseases. Frailty is a common clinical syndrome in older adults, affecting 7-12% of the older population, and the occurrence of frailty increases with age and may exceed 45% after age 85 years. Frailty develops when age-associated degenerative processes overwhelm reserve capacity and reparative processes that maintain function of the nervous system as well as other physiologic systems. Overall, frailty consists in the vulnerability of aged population to adverse events as the result of the subtle and progressive metabolic and physical changes. Frailty confers a significantly increased risk for poor health outcomes, incident disability, hospitalization, and mortality.
In recent years there has been an emergence of information and communication technology (ICT) -based solutions to support active ageing and tackle frailty, cognitive decline and social isolation of older adults. While these ICT-based solutions are of a certain value regarding diminishing single risks (e.g. fall risk, etc.), there is still a need for a more holistic approach which aims to address all of the individual risk factors together. Also it is necessary to provide tailored interventions based on the outcomes of the risk analysis. This assessment of risk for frailty and provision of individual tailored interventions is the main objective of My-AHA project.
My-AHA solution supports active and healthy ageing by enabling early detection and minimization of risks associated with ageing. In these terms the early risk detection considers three fundamental aspects of the life of older adults: physical activity (by considering vital signs data, gait, quality of sleep and in general, physical activity, and fall risk); cognitive activity (by monitor the cognitive level, e.ge.g. in cognitive games); and, psychosocial activities (e.g. by analyzing the emotions and the quality of speech of the users). On the other hand, My-AHA will develop and implement more efficient and effective ICT-based interventions tailored to the early identified risks. The suggested social activities, as well as cognitive and physical trainings and the diet proposed to the older adults via the new platform will help the users in changing their behaviour and in reacting to the consequences of ageing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | Active comparator | Other: My-AHA platformPre-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. |
| Controls | Placebo comparator | Other: My-AHA platformPre-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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (52 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My-AHA platformICT strategy for early detection of frailties | Other | Cases, Controls |
Primary outcome
Conversion rate from a pre-frail status to a frail status (Fried criteria)
Time frame: 18 months
Comparison of conversion rate in cases and controls between pre-frail status fo frail status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Background: PubMed 25783624Choi 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.
- Background: PubMed 27324809Kojima 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.
- Background: PubMed 22426304Shamliyan 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.
- Background: PubMed 21968870Panza 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.
- Background: PubMed 11253156Fried 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Aumayr, PhD principal investigator
Johanniter International
Helios De Rosario, PhD principal investigator
IBV-Gesmed, Spain
Mathew Summers, PhD principal investigator
Sunshine Coast University, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My-AHA platform in people with Frail Elderly Syndrome and Cognitive Impairment, run by University of Turin, Italy at 1 site in Italy.
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 13 inclusion and 52 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: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate from a pre-frail status to a frail status (Fried criteria) (time frame: 18 months). 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 NCT03342976, which also lists 5 linked publications.
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 30 Nov 2023.