Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs (POSITIVE)

Hospital Universitario Getafe

Status: Unknown

Conditions: Frailty Syndrome; Frailty; Frail Elderly Syndrome

Treatments: Device: Frailty multicomponent intervention supported by POSITIVE; Other: Frailty multicomponent intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04592146

POSITIVE

Details and patient eligibility

About

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.

Full 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)).

Enrollment: 150 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Other: Frailty multicomponent intervention

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Frailty multicomponent intervention

Device: Frailty multicomponent intervention supported by POSITIVE