POSITIVE: Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 150
- Locations
- 3
- Primary Endpoint
- Frailty status 1
Study Overview
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)).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Living at home.
- •Having a caregiver/relative and/or supervision at home.
- •Barthel ≥
- •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.
Arms & Interventions
Control group
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.
Intervention: Frailty multicomponent intervention (Other)
Intervention group
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.
Intervention: Frailty multicomponent intervention supported by POSITIVE (Device)
Intervention group
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.
Intervention: Frailty multicomponent intervention (Other)
Outcomes
Primary Outcomes
Frailty status 1
Time Frame: 6 months
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).
Frailty status 2
Time Frame: 6 months
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.
Secondary Outcomes
- Disability(6 months)
- Instrumental activities of daily living (IADL)(6 months)
- Health-related quality of life(6 months)
- Cognitive impairment 1(6 months)
- Cognitive impairment 2(6 months)
- Affective sphere(6 months)
- Caregiver quality of life(6 months)
- To evaluate the usability of the POSITIVE system according to the System Usability Scale (SUS).(6 months)
- 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)