Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs

ClinicalTrials.gov ID

NCT04592146

Lead Sponsor

Hospital Universitario GetafeOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

150Estimated

Last Update Posted

Feb 12, 2021Actual

Start Date

Nov 1, 2020Actual

Primary Completion Date

Jun 30, 2021Estimated

Completion Date

Jun 30, 2021Estimated

Official Title

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

Brief 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.

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)).

• Frailty
• Frailty Syndrome
• Frail Elderly Syndrome

• Frailty multicomponent intervention supported by POSITIVE
• Frailty multicomponent intervention

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Hospital Universitario GetafeOTHER

Collaborators

Karolinska InstitutetOTHER

Medical University of LodzOTHER

Universidad Politecnica de MadridOTHER

KTH Royal Institute of TechnologyOTHER

Fundación para la Investigación Biomédica - Hospital Universitario de GetafeUNKNOWN

susanne.guidetti@ki.se+46 (0)739 661636

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