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

H

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

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

Trial contacts and locations

0

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Central trial contact

Leocadio Rodríguez-Mañas, MD, PhD; Rodrigo Pérez-Rodríguez, PhD

Data sourced from clinicaltrials.gov

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