Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs
NCT ID: NCT04592146
Last Updated: 2021-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2020-11-01
2021-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
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.
Frailty multicomponent intervention
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.
Intervention group
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.
Frailty multicomponent intervention supported by POSITIVE
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 intervention
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.
Interventions
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Frailty multicomponent intervention supported by POSITIVE
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 intervention
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.
Eligibility Criteria
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Inclusion Criteria
* Living at home.
* Having a caregiver/relative and/or supervision at home.
* Barthel ≥ 90.
* Meet at least 1 criterion from Fried's Criteria.
Exclusion Criteria
* 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.
70 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Medical University of Lodz
OTHER
Universidad Politecnica de Madrid
OTHER
KTH Royal Institute of Technology
OTHER
Fundación para la Investigación Biomédica - Hospital Universitario de Getafe
UNKNOWN
Hospital Universitario Getafe
OTHER
Responsible Party
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Principal Investigators
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Leocadio Rodríguez-Mañas, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario de Getafe
Rodrigo Pérez-Rodríguez, PhD
Role: PRINCIPAL_INVESTIGATOR
FIB-Hospital Universitario de Getafe
Locations
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Medical University of Lodz
Lodz, , Poland
Fundación para la Investigación Biomédica - Hospital Universitario de Getafe
Getafe, Madrid, Spain
Karolinska Institutet
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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Website to the project site within the EIT-Health website (funding body) European Institute of Innovation \& technology
Other Identifiers
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POSITIVE
Identifier Type: -
Identifier Source: org_study_id
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