Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs

Frailty Clinical Trial

— POSITIVE  

Official title:

POSITIVE: Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04592146
• Other study ID #: POSITIVE
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2020
• Source: Hospital Universitario Getafe
• Contact: Rodrigo Pérez-Rodríguez, PhD
• Phone: +34657994364
• Email: rprodrigo[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Frailty
• Frailty Syndrome
• Syndrome

Intervention

Device:
• Frailty multicomponent intervention supported by POSITIVE
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

Other:
• Frailty multicomponent intervention
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.

Locations

Country	Name	City	State
Poland	Medical University of Lodz	Lodz
Spain	Fundación para la Investigación Biomédica - Hospital Universitario de Getafe	Getafe	Madrid
Sweden	Karolinska Institutet	Stockholm

Sponsors (6)

Lead Sponsor	Collaborator
Hospital Universitario Getafe	Fundación para la Investigación Biomédica - Hospital Universitario de Getafe, Karolinska Institutet, KTH Royal Institute of Technology, Medical Universtity of Lodz, Universidad Politecnica de Madrid

Countries where clinical trial is conducted

Poland,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Frailty trajectories 1	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	6 months
Secondary	Frailty trajectories 2	To evaluate whether the POSITIVE system improves frailty transitions in pre-frail and frail participants according to FTS-5.	6 months
Secondary	Physical function 1	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.	6 months
Secondary	Physical function 2	To evaluate whether the POSITIVE system improves participants' physical performance according to the Gait Speed test (meters/second)	6 months
Secondary	Basic activities daily living (BADL)	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.	6 months
Secondary	Disability	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)	6 months
Secondary	Instrumental activities of daily living (IADL)	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.	6 months
Secondary	Health-related quality of life	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.	6 months
Secondary	Cognitive impairment 1	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.	6 months
Secondary	Cognitive impairment 2	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)	6 months
Secondary	Affective sphere	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.	6 months
Secondary	Caregiver quality of life	To evaluate the influence of the POSITIVE system on the caregiver quality of life according EuroQoL-5D-5L.	6 months
Secondary	To evaluate the usability of the POSITIVE system according to the System Usability Scale (SUS).	SUS ranges from 0 to 100. A SUS score above a 68 would be considered above average and anything below 68 is below average..	6 months

External Links

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