NCT04592146: POSITIVE

Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs

Status unknown NA Last updated 12 February 2021

What this trial tests

NA trial testing Frailty multicomponent intervention supported by POSITIVE in Frailty in 150 participants. Status unknown.

Timeline

1 November 2020

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Hospital Universitario Getafe
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	1 November 2020
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	3 locations across Spain, Poland, Sweden

Drugs / interventions tested

• Frailty multicomponent intervention supported by POSITIVE
• Frailty multicomponent intervention

Conditions studied

• Frailty — all drugs for Frailty →
• Frailty Syndrome — all drugs for Frailty Syndrome →
• Frail Elderly Syndrome — all drugs for Frail Elderly Syndrome →

Sponsor

Hospital Universitario Getafe

Who can join

70 and older, any sex, with Frailty or Frailty Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Integrated health system to assess and manage frailty in community dwelling: Co-design and usability evaluation.
   Moral C, Pérez-Rodríguez R, Villalba-Mora E, Barrio-Cortes J, et al · · 2023 · cited 6× · PMID 37361432 · DOI 10.1177/20552076231181229
2. 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.
   Teriö M, Pérez-Rodríguez R, Guevara Guevara T, Valdes-Aragonés M, et al · · 2022 · cited 6× · PMID 35999616 · DOI 10.1186/s40814-022-01147-4
3. Usability, User Experience, and Acceptance Evaluation of CAPACITY: A Technological Ecosystem for Remote Follow-Up of Frailty.
   Pérez-Rodríguez R, Villalba-Mora E, Valdés-Aragonés M, Ferre X, et al · · 2021 · cited 4× · PMID 34640777 · DOI 10.3390/s21196458
4. Full GSA 2024 Abstract Book PDF
   · 2024
5. FRAILTY THERAPEUTICS: CLOSING THE PHYSICAL ACTIVITY GAP FOR FRAIL ADULTS
   · 2024
6. THE POTENTIAL FOR MIND–BODY THERAPIES AS FRAILTY INTERVENTIONS
   · 2024
7. EFFECTIVENESS OF A TECHNOLOGICAL PLATFORM TO MANAGE FRAILTY: RESULTS FROM THE POSITIVE AND INTEGRACAM STUDIES
   · 2024
8. EMPOWERING FRAIL OLDER ADULTS THROUGH DIGITAL LITERACY: A THEORY AND VALUES-BASED INTERVENTION
   · 2024