Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs

NCT04592146 | Unknown DMC

• 1 other identifier: POSITIVE
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 3

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.

Conditions

Frailty; Frailty Syndrome; Frail Elderly Syndrome

Keywords

Frailty; Technology; Home monitoring; Older persons

Outcome Measures

Primary Outcomes (2)

• Frailty status 1

  Evaluation of the impact of the technology supported intervention in terms of frailty measured with the Linda Fried's criteria. This test ranges from 0 to 5 (0: robust; 1-2: pre-frailty; +2: frailty).

  6 months

• Frailty status 2

  To evaluate whether a multimodal intervention supported by the POSITIVE technological ecosystem improves frailty in at least 5 points in Frail trait scale (FTS-5) during a 6-month follow-up period. FTS scores between 0-50. 0 is the best value and 50 the worst value.

  6 months

Secondary Outcomes (13)

• Frailty trajectories 1

  6 months

• Frailty trajectories 2

  6 months

• Physical function 1

  6 months

• Physical function 2

  6 months

• Basic activities daily living (BADL)

  6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Other: Frailty multicomponent intervention

Intervention group

EXPERIMENTAL

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.

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

Interventions

Frailty multicomponent intervention supported by POSITIVE DEVICE

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

Intervention group

Frailty multicomponent intervention OTHER

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.

Control group; Intervention group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Getafe: lead
• Karolinska Institutet: collaborator
• Medical University of Lodz: collaborator
• Universidad Politecnica de Madrid: collaborator
• KTH Royal Institute of Technology: collaborator
• Fundación para la Investigación Biomédica - Hospital Universitario de Getafe: collaborator

Study Sites (3)

Medical University of Lodz

Lodz, 90-419, Poland

NOT YET RECRUITING

Fundación para la Investigación Biomédica - Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

RECRUITING

Karolinska Institutet

Stockholm, 14183, Sweden

NOT YET RECRUITING

Related Publications (1)

• Terio M, Perez-Rodriguez R, Guevara Guevara T, Valdes-Aragones M, Kornevs M, Bjalevik-Chronan S, Taloyan M, Meijer S, Guidetti S. 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. Pilot Feasibility Stud. 2022 Aug 23;8(1):190. doi: 10.1186/s40814-022-01147-4.

  PMID: 35999616 DERIVED

Related Links

• Website to the project site within the EIT-Health website (funding body) European Institute of Innovation \& technology

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leocadio Rodríguez-Mañas, MD, PhD

  Hospital Universitario de Getafe

  PRINCIPAL INVESTIGATOR

• Rodrigo Pérez-Rodríguez, PhD

  FIB-Hospital Universitario de Getafe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo Pérez-Rodríguez, PhD

CONTACT

+34657994364; rprodrigo@salud.madrid.org

Leocadio Rodríguez-Mañas, MD, PhD

CONTACT

leocadio.rodriguez@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-centre, non-inferiority, randomized, simple blind and prospective pilot study.

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 19, 2020
• Study Start: November 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: February 12, 2021

Record last verified: 2020-10

Locations

ES (1); PL (1); SE (1)