Clinical trial NCT04592146: Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs
Official title: POSITIVE: Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Frailty Syndrome
Frail Elderly Syndrome
Keywords: Frailty
Technology
Home monitoring
Older persons
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Medical University of Lodz
name: Universidad Politecnica de Madrid
name: KTH Royal Institute of Technology
name: Fundación para la Investigación Biomédica - Hospital Universitario de Getafe
First posted: 2020-10-19
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-centre, non-inferiority, randomized, simple blind and prospective pilot study.
Primary purpose: TREATMENT

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)).

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 outcomes:
measure: Frailty status 1
timeFrame: 6 months
measure: Frailty status 2
timeFrame: 6 months
Secondary outcomes:
measure: Frailty trajectories 1
timeFrame: 6 months
measure: Frailty trajectories 2
timeFrame: 6 months
measure: Physical function 1
timeFrame: 6 months
measure: Physical function 2
timeFrame: 6 months
measure: Basic activities daily living (BADL)
timeFrame: 6 months
measure: Disability
timeFrame: 6 months
measure: Instrumental activities of daily living (IADL)
timeFrame: 6 months
measure: Health-related quality of life
timeFrame: 6 months
measure: Cognitive impairment 1
timeFrame: 6 months
measure: Cognitive impairment 2
timeFrame: 6 months
measure: Affective sphere
timeFrame: 6 months
measure: Caregiver quality of life
timeFrame: 6 months
measure: To evaluate the usability of the POSITIVE system according to the System Usability Scale (SUS).
timeFrame: 6 months
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Medical University of Lodz
city: Getafe
country: Spain
facility: Fundación para la Investigación Biomédica - Hospital Universitario de Getafe
state: Madrid
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Hospital Universitario de Getafe
name: Leocadio Rodríguez-Mañas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: FIB-Hospital Universitario de Getafe
name: Rodrigo Pérez-Rodríguez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.