Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs
- Conditions
- Frailty SyndromeFrail Elderly SyndromeFrailty
- Interventions
- Device: Frailty multicomponent intervention supported by POSITIVEOther: Frailty multicomponent intervention
- Registration Number
- NCT04592146
- Lead Sponsor
- Hospital Universitario Getafe
- 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)).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Frailty multicomponent intervention supported by POSITIVE 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 group Frailty multicomponent intervention 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. Control group Frailty multicomponent intervention 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.
- Primary Outcome Measures
Name Time Method Frailty status 1 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 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 Outcome Measures
Name Time Method Disability 6 months To evaluate the influence of the POSITIVE system in patients' autonomy every day life (instrumental activities) according to WHO Disability Assessment Schedule (WHODAS 2.0). Score between 0 to 100 (where 0 = no disability; 100 = full disability)
Instrumental activities of daily living (IADL) 6 months To evaluate the influence of the POSITIVE system in patients' autonomy every day life (instrumental activities) according to the Lawton and Brody scale. Lawton and Brody scale scores between 0-10; 0 is the worst and 10 the best value.
Health-related quality of life 6 months To evaluate the influence of the POSITIVE system in the quality of life according to the European Quality of life 5 dimensions-5 levels (EuroQoL 5D-5L). EuroQoL scores between 0-10 and 10 is the worst quality of life.
Cognitive impairment 1 6 months To evaluate the influence of the POSITIVE system in the cognitive sphere according to the MONTREAL COGNITIVE ASSESSMENT (MoCA test). Scores between 0-30 being 30 the best value.
Cognitive impairment 2 6 months To evaluate the influence of the POSITIVE system in the cognitive sphere according to the clock drawing test. Score ranges between 0-10. \<8 suggests that cognitive impairment (CI)
Affective sphere 6 months To evaluate the influence of the POSITIVE system in the affective sphere according Geriatric Depression Scale (GDS). Each answer indicating depression (bold 'yes' or 'no) counts one point. Scores greater than 5 are indicative of probable depression.
In the experimental site located in Sweden, the version of this scale will be used.Caregiver quality of life 6 months To evaluate the influence of the POSITIVE system on the caregiver quality of life according EuroQoL-5D-5L.
To evaluate the usability of the POSITIVE system according to the System Usability Scale (SUS). 6 months SUS ranges from 0 to 100. A SUS score above a 68 would be considered above average and anything below 68 is below average..
Frailty trajectories 1 6 months Trajectories of frailty according to changes in Fried´s phenotype. Fried´s Phenotype scores between 0 and 5. 0 means robust; 1-2 mean pre-frail and 3 or more mean frail
Frailty trajectories 2 6 months To evaluate whether the POSITIVE system improves frailty transitions in pre-frail and frail participants according to FTS-5.
Physical function 1 6 months To evaluate whether the POSITIVE system improves participants' physical performance according to the Short Physical Performance Battery (SPPB).SPPB scores between 0-12. 0 is the worst and 12 the best value.
Physical function 2 6 months To evaluate whether the POSITIVE system improves participants' physical performance according to the Gait Speed test (meters/second)
Basic activities daily living (BADL) 6 months To evaluate the influence of the POSITIVE system in patients' autonomy every day life (basic activities) according to the Barthel Index. Barthel scores between 0-100; 0 is the worst value and 100 the best.
Trial Locations
- Locations (3)
Medical University of Lodz
🇵🇱Lodz, Poland
Karolinska Institutet
🇸🇪Stockholm, Sweden
Fundación para la Investigación Biomédica - Hospital Universitario de Getafe
🇪🇸Getafe, Madrid, Spain