Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs

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.

Conditions

• Frailty
• Frailty Syndrome
• Frail Elderly Syndrome

Interventions

DEVICE

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

OTHER

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.

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Medical University of Lodz

  collaborator OTHER

• Universidad Politecnica de Madrid

  collaborator OTHER

• KTH Royal Institute of Technology

  collaborator OTHER

• Fundación para la Investigación Biomédica - Hospital Universitario de Getafe

  collaborator UNKNOWN

• Hospital Universitario Getafe

  lead OTHER

Principal Investigators

• Leocadio Rodríguez-Mañas, MD, PhD · Hospital Universitario de Getafe

• Rodrigo Pérez-Rodríguez, PhD · FIB-Hospital Universitario de Getafe

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-01

Primary Completion

2021-06-30

Completion

2021-06-30

Countries

• Poland
• Spain
• Sweden

Study Locations