Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs

Study Overview
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Brief Summary
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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
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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)).

Official Title
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POSITIVE: Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs

Conditions
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Frailty, Frailty Syndrome, Frail Elderly Syndrome

Intervention / Treatment
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* Device: Frailty multicomponent intervention supported by POSITIVE
* Other: Frailty multicomponent intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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. Exclusion criteria: 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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-centre, non-inferiority, randomized, simple blind and prospective pilot study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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. | Other: Frailty multicomponent intervention<br>* 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.<br>|
| Experimental: Intervention group<br>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. | Device: Frailty multicomponent intervention supported by POSITIVE<br>* 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<br>Other: Frailty multicomponent intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 
| Frailty trajectories 2 | To evaluate whether the POSITIVE system improves frailty transitions in pre-frail and frail participants according to FTS-5. | 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. | 6 months | 
| Physical function 2 | To evaluate whether the POSITIVE system improves participants' physical performance according to the Gait Speed test (meters/second) | 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. | 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) | 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. | 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. | 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. | 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) | 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. | 6 months | 
| Caregiver quality of life | To evaluate the influence of the POSITIVE system on the caregiver quality of life according EuroQoL-5D-5L. | 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.. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Technology, Home monitoring, Older persons