FrailtyPOSITIVENCT04592146
Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs
A study testing Frailty multicomponent intervention supported by POSITIVE and Frailty multicomponent intervention in people with Frailty and Frailty Syndrome, run by Hospital Universitario Getafe at 3 sites in 3 countries.
Trial summary
The POSITIVE platform offers the possibility of unsupervised monitoring of pre-frailty and frailty status in a community setting, to detect the onset of frailty and to assess its evolution. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty, Frailty Syndrome, Frail Elderly Syndrome
- What is being tested?
- Frailty multicomponent intervention supported by POSITIVE and Frailty multicomponent intervention
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Nov 2020to 30 Jun 2021
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 70.
- Living at home.
- Having a caregiver/relative and/or supervision at home.
- Barthel ≥ 90.
- Meet at least 1 criterion from Fried's Criteria.
Who cannot join
- Inadequate home infrastructure to host the required technology.
- Inability to understand on how to use the POSITIVE system by the participant.
- Diseases that may affect prescription therapy:
- History of alcohol/drugs abuse.
- Living with another participant.
- Participating in other clinical studies.
- Three or more hospitalizations in the last year.
Trial locations and contacts
3 sites in 3 countries.
Leocadio Rodríguez-Mañas, MD, PhD contact
3 sites in 3 countries
Poland1 site, 1 recruiting
- Not yet recruiting
Medical University of Lodz
Lodz, 90-419
Tomasz Kostka, PhD, +48 426793144 ext. 251, tomasz.kostka@umed.lodz.pl
Tomasz Kostka, PhD
Spain1 site, 1 recruiting
- Recruiting
Fundación para la Investigación Biomédica - Hospital Universitario de Getafe
Getafe, Madrid, 28905
Rodrigo Pérez-Rodríguez, PhD, +34657994364, rprodrigo@salu.madrid.org
Leocadio Rodríguez-Mañas, PdD
Sweden1 site, 1 recruiting
- Not yet recruiting
Karolinska Institutet
Stockholm, 14183
Susanne GE Guidetti, PhD, +46 (0)739 661636, susanne.guidetti@ki.se
Susanne GE Guidetti, MsC
About this study
Official title: POSITIVE: Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs
The POSITIVE platform offers the possibility of unsupervised monitoring of pre-frailty and frailty status in a community setting, to detect the onset of frailty and to assess its evolution.
The primary objective of the study is to evaluate whether the POSITIVE system improves frailty in at least 1 point in the Fried's Criteria and 5 points in the FTS-5.
This is a multi-centre, non-inferiority, randomized, simple blind and prospective pilot study with a 12-month follow up duration. The study will be carried out in Spain, Sweden and Poland. 150 participants will be randomized into two groups. The control group will receive usual medical care. The intervention group will receive, in addition, the POSITIVE frailty home monitoring and intervention system.
Read the detailed description
The primary endpoints is to evaluate whether a multimodal intervention supported by the POSITIVE technological ecosystem improves frailty in at least 1 point in Fried's Criteria and 5 points in FTS-5 during a 6-month follow-up period.
This objective will be investigated through a multi-centre, non-inferiority, randomized, simple blind and prospective pilot study with an intervention lasting for 6 months. The study will be carried out in Spain, Sweden and Poland. 150 participants (50 per site) will be randomized into two groups. The control group will receive usual medical care. The intervention group will receive, in addition, the POSITIVE frailty home monitoring and intervention system.
Both groups will be assessed with the same instruments. This assessment will be conducted at baseline (in the beginning of the trial period), at the middle (month 3) and at the end of the intervention (month 6).
A stratified randomization technique will be applied in each of the study groups based on: age group (70-85,> 85), history of cognitive impairment, history of stroke to guarantee the existence of comparable groups. These factors have been significantly associated with frailty and pre-frailty status (stroke OR =3.11 (1.05-9.18), age, per 1-year OR = 1.14 (1.08-1.21); cognitive impairment OR = 8.37 (4.43-15.83)).
- Conditions
- Frailty, Frailty Syndrome, Frail Elderly Syndrome
- Being tested
- Frailty multicomponent intervention supported by POSITIVE, Frailty multicomponent intervention
- Keywords
- Frailty, Technology, Home monitoring, Older persons
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty multicomponent intervention supported by POSITIVEDevice
This technology mainly consists in a home monitoring kit periodically measuring gait speed, involuntary weight loss and power in the lower limb. Furthermore, through a tablet device, other relevant information (e.g. state of mind, activities of daily living-ADLs, etc.) is collected. The same device is used to enhance communication with the clinical team and follow the tailored intervention
Frailty multicomponent interventionOther
This intervention is based on 3 main pillars: medication review (to avoid polypharmacy), tailored nutritional recommendations and a tailored physical activity plan based on the VIVIFRAIL program.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Participants randomized into the intervention group will receive care according to the current organizational model in each pilot site (managed by community care). Frailty care will consist in a multicomponent intervention. Receives: Other: Frailty multicomponent intervention |
| Intervention group | Experimental | Participants randomized into the intervention group will receive the same intervention as those allocated into the control group, but this intervention will be supported by the POSITIVE technology.Informal caregivers will also receive an app to follow the evolution of the cared person.
As in the control group, participants allocated into the intervention group will be managed by community care; these professionals will have access to the evolution of the older persons so they can take promote actions in case early deterioration is detected. Receives: Device: Frailty multicomponent intervention supported by POSITIVE; Other: Frailty multicomponent intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty status 1
Evaluation of the impact of the technology supported intervention in terms of frailty measured with the Linda Fried's criteria. This test ranges from 0 to 5 (0: robust; 1-2: pre-frailty; +2: frailty).
Measured: 6 months
Frailty status 2
To evaluate whether a multimodal intervention supported by the POSITIVE technological ecosystem improves frailty in at least 5 points in Frail trait scale (FTS-5) during a 6-month follow-up period. FTS scores between 0-50. 0 is the best value and 50 the worst value.
Measured: 6 months
Secondary outcomes (13)
Frailty trajectories 1
Trajectories of frailty according to changes in Fried´s phenotype. Fried´s Phenotype scores between 0 and 5. 0 means robust; 1-2 mean pre-frail and 3 or more mean frail
Measured: 6 months
Frailty trajectories 2
To evaluate whether the POSITIVE system improves frailty transitions in pre-frail and frail participants according to FTS-5.
Measured: 6 months
Physical function 1
To evaluate whether the POSITIVE system improves participants' physical performance according to the Short Physical Performance Battery (SPPB).SPPB scores between 0-12. 0 is the worst and 12 the best value.
Measured: 6 months
Physical function 2
To evaluate whether the POSITIVE system improves participants' physical performance according to the Gait Speed test (meters/second)
Measured: 6 months
Basic activities daily living (BADL)
To evaluate the influence of the POSITIVE system in patients' autonomy every day life (basic activities) according to the Barthel Index. Barthel scores between 0-100; 0 is the worst value and 100 the best.
Measured: 6 months
Disability
To evaluate the influence of the POSITIVE system in patients' autonomy every day life (instrumental activities) according to WHO Disability Assessment Schedule (WHODAS 2.0). Score between 0 to 100 (where 0 = no disability; 100 = full disability)
Measured: 6 months
Instrumental activities of daily living (IADL)
To evaluate the influence of the POSITIVE system in patients' autonomy every day life (instrumental activities) according to the Lawton and Brody scale. Lawton and Brody scale scores between 0-10; 0 is the worst and 10 the best value.
Measured: 6 months
Health-related quality of life
To evaluate the influence of the POSITIVE system in the quality of life according to the European Quality of life 5 dimensions-5 levels (EuroQoL 5D-5L). EuroQoL scores between 0-10 and 10 is the worst quality of life.
Measured: 6 months
Cognitive impairment 1
To evaluate the influence of the POSITIVE system in the cognitive sphere according to the MONTREAL COGNITIVE ASSESSMENT (MoCA test). Scores between 0-30 being 30 the best value.
Measured: 6 months
Cognitive impairment 2
To evaluate the influence of the POSITIVE system in the cognitive sphere according to the clock drawing test. Score ranges between 0-10. <8 suggests that cognitive impairment (CI)
Measured: 6 months
Affective sphere
To evaluate the influence of the POSITIVE system in the affective sphere according Geriatric Depression Scale (GDS). Each answer indicating depression (bold 'yes' or 'no) counts one point. Scores greater than 5 are indicative of probable depression.
In the experimental site located in Sweden, the version of this scale will be used.
Measured: 6 months
Caregiver quality of life
To evaluate the influence of the POSITIVE system on the caregiver quality of life according EuroQoL-5D-5L.
Measured: 6 months
To evaluate the usability of the POSITIVE system according to the System Usability Scale (SUS).
SUS ranges from 0 to 100. A SUS score above a 68 would be considered above average and anything below 68 is below average..
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Nov 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre, non-inferiority, randomized, simple blind and prospective pilot study.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Medical University of Lodz, Universidad Politecnica de Madrid, KTH Royal Institute of Technology, Fundación para la Investigación Biomédica - Hospital Universitario de Getafe
- Responsible party
- Sponsor
- Investigators
- Leocadio Rodríguez-Mañas, MD, PhD, Principal investigator, Hospital Universitario de GetafeRodrigo Pérez-Rodríguez, PhD, Principal investigator, FIB-Hospital Universitario de Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592146
- Sponsor's protocol ID
- POSITIVE
- Acronym
- POSITIVE
- Status last verified
- Oct 2020
- First submitted
- 30 Sep 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Terio M, Perez-Rodriguez R, Guevara Guevara T, Valdes-Aragones M, Kornevs M, Bjalevik-Chronan S, Taloyan M, Meijer S, Guidetti S. Preventing frailty with the support of a home-monitoring and communication platform among older adults-a study protocol for a randomised-controlled pilot study in Sweden. Pilot Feasibility Stud. 2022 Aug 23;8(1):190. doi: 10.1186/s40814-022-01147-4.
PubMed 35999616
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POSITIVE: Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs
- ClinicalTrials.gov ID
- NCT04592146
- Acronym / sponsor ID
- POSITIVE / POSITIVE
- Conditions
- Frailty, Frailty Syndrome, Frail Elderly Syndrome
- Keywords
- Frailty, Technology, Home monitoring, Older persons
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Medical University of Lodz, Universidad Politecnica de Madrid, KTH Royal Institute of Technology, Fundación para la Investigación Biomédica - Hospital Universitario de Getafe
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 19 Oct 2020 (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.
The POSITIVE platform offers the possibility of unsupervised monitoring of pre-frailty and frailty status in a community setting, to detect the onset of frailty and to assess its evolution.
The primary objective of the study is to evaluate whether the POSITIVE system improves frailty in at least 1 point in the Fried's Criteria and 5 points in the FTS-5.
This is a multi-centre, non-inferiority, randomized, simple blind and prospective pilot study with a 12-month follow up duration. The study will be carried out in Spain, Sweden and Poland. 150 participants will be randomized into two groups. The control group will receive usual medical care. The intervention group will receive, in addition, the POSITIVE frailty home monitoring and intervention system.
Detailed description
The primary endpoints is to evaluate whether a multimodal intervention supported by the POSITIVE technological ecosystem improves frailty in at least 1 point in Fried's Criteria and 5 points in FTS-5 during a 6-month follow-up period.
This objective will be investigated through a multi-centre, non-inferiority, randomized, simple blind and prospective pilot study with an intervention lasting for 6 months. The study will be carried out in Spain, Sweden and Poland. 150 participants (50 per site) will be randomized into two groups. The control group will receive usual medical care. The intervention group will receive, in addition, the POSITIVE frailty home monitoring and intervention system.
Both groups will be assessed with the same instruments. This assessment will be conducted at baseline (in the beginning of the trial period), at the middle (month 3) and at the end of the intervention (month 6).
A stratified randomization technique will be applied in each of the study groups based on: age group (70-85,> 85), history of cognitive impairment, history of stroke to guarantee the existence of comparable groups. These factors have been significantly associated with frailty and pre-frailty status (stroke OR =3.11 (1.05-9.18), age, per 1-year OR = 1.14 (1.08-1.21); cognitive impairment OR = 8.37 (4.43-15.83)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-centre, non-inferiority, randomized, simple blind and prospective pilot study.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Frailty multicomponent interventionParticipants randomized into the intervention group will receive care according to the current organizational model in each pilot site (managed by community care). Frailty care will consist in a multicomponent intervention. |
| Intervention group | Experimental | Device: Frailty multicomponent intervention supported by POSITIVE, Other: Frailty multicomponent interventionParticipants randomized into the intervention group will receive the same intervention as those allocated into the control group, but this intervention will be supported by the POSITIVE technology.Informal caregivers will also receive an app to follow the evolution of the cared person. As in the control group, participants allocated into the intervention group will be managed by community care; these professionals will have access to the evolution of the older persons so they can take promote actions in case early deterioration is detected. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 70.
- Living at home.
- Having a caregiver/relative and/or supervision at home.
- Barthel ≥ 90.
- Meet at least 1 criterion from Fried's Criteria.
Key exclusion criteria (7 listed)
- Inadequate home infrastructure to host the required technology.
- Inability to understand on how to use the POSITIVE system by the participant.
- Diseases that may affect prescription therapy:
- History of alcohol/drugs abuse.
- Living with another participant.
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 |
|---|---|---|
| Frailty multicomponent intervention supported by POSITIVEThis technology mainly consists in a home monitoring kit periodically measuring gait speed, involuntary weight loss and power in the lower limb. Furthermore, through a tablet device, other relevant information (e.g. state of mind, activities of daily living-ADLs, etc.) is collected. The same device is used to enhance communication with the clinical team and follow the tailored intervention | Device | Intervention group |
| Frailty multicomponent interventionThis intervention is based on 3 main pillars: medication review (to avoid polypharmacy), tailored nutritional recommendations and a tailored physical activity plan based on the VIVIFRAIL program. | Other | Control group, Intervention group |
Primary outcome
Frailty status 1
Time frame: 6 months
Evaluation of the impact of the technology supported intervention in terms of frailty measured with the Linda Fried's criteria. This test ranges from 0 to 5 (0: robust; 1-2: pre-frailty; +2: frailty).
Frailty status 2
Time frame: 6 months
To evaluate whether a multimodal intervention supported by the POSITIVE technological ecosystem improves frailty in at least 5 points in Frail trait scale (FTS-5) during a 6-month follow-up period. FTS scores between 0-50. 0 is the best value and 50 the worst value.
13 secondary outcomes
Frailty trajectories 1
Time frame: 6 months
Frailty trajectories 2
Time frame: 6 months
Physical function 1
Time frame: 6 months
Physical function 2
Time frame: 6 months
Basic activities daily living (BADL)
Time frame: 6 months
Disability
Time frame: 6 months
Instrumental activities of daily living (IADL)
Time frame: 6 months
Health-related quality of life
Time frame: 6 months
Cognitive impairment 1
Time frame: 6 months
Cognitive impairment 2
Time frame: 6 months
Affective sphere
Time frame: 6 months
Caregiver quality of life
Time frame: 6 months
To evaluate the usability of the POSITIVE system according to the System Usability Scale (SUS).
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Derived from this study: PubMed 35999616Terio M, Perez-Rodriguez R, Guevara Guevara T, Valdes-Aragones M, Kornevs M, Bjalevik-Chronan S, Taloyan M, Meijer S, Guidetti S. Preventing frailty with the support of a home-monitoring and communication platform among older adults-a study protocol for a randomised-controlled pilot study in Sweden. Pilot Feasibility Stud. 2022 Aug 23;8(1):190. doi: 10.1186/s40814-022-01147-4.
- Website to the project site within the EIT-Health website (funding body) European Institute of Innovation \& technologyLink provided by the sponsor.
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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.
Leocadio Rodríguez-Mañas, MD, PhD contact
Leocadio Rodríguez-Mañas, MD, PhD principal investigator
Hospital Universitario de Getafe
Rodrigo Pérez-Rodríguez, PhD principal investigator
FIB-Hospital Universitario de Getafe
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frailty multicomponent intervention supported by POSITIVE and Frailty multicomponent intervention in people with Frailty and Frailty Syndrome, run by Hospital Universitario Getafe at 3 sites in 3 countries.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland, Spain, Sweden. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Pérez-Rodríguez, PhD (+34657994364, rprodrigo@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty status 1 (time frame: 6 months). The study lists 2 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 NCT04592146, which also lists 1 linked publication.
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 12 Feb 2021.