Remote Monitoring to Prevent Frailty Progression in the Elderly

NCT05173870 | Terminated

• 1 other identifier: DEP_022021
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Frailty is a frequent condition in elderly, characterized by reduced physiologic reserve, leading to an increased risk for adverse events, such as disability, hospitalization, and death. In particular, it is a multidimensional disfunctional condition, including decreases in physiologic capacity in neurologic control (indicated by diminished ability to perform complex tasks), mechanical performance (e.g. diminished strength), and energy metabolism (e.g. decreased aerobic status due to cardiac or pulmonary diseases or both). All these factors lead to the worsening of quality of life. Focusing on the great impact of this condition in global population and the rising of social/health costs, related to this condition, frailty is earning a great interest from both at political level and European Community. For this reason, developing interventions programs aiming to prevent the progression of frailty towards the independence loss, it is considered a key objective for the improvement of the quality of life. In this context, this pilot study looks at the standardization of a study protocol to develop a useful model for enhancing local care in small population isolates, by remotely monitoring the health status of pre-frail subjects and improving the progression of the frailty condition, in order to support a healthy ageing for future investigation including a larger number of individuals.

Conditions

Frailty; Elderly; Wearable Device

Keywords

Frailty; Wearable device; Elderly; Health status monitoring

Outcome Measures

Primary Outcomes (1)

• Study protocol assessment

  To standardize a study protocol to develop a useful model for enhancing local care in small population isolates, by remotely monitoring the health status of pre-frail subjects and improving the progression of the frailty condition in order to support a healthy ageing for future investigation including a larger number of individuals.

  From February 2022 to August 2023

Secondary Outcomes (4)

• Recruitment phase

  From February 2022 to May 2022

• Training Phase

  From February 2022 to May 2022

• Pre-frail subjects responsiveness

  From February 2022 to August 2022

• Wearable device compliance

  From February 2022 to August 2022

Interventions

Wearable device DEVICE

The wearable devices has a biosensor able to daily collect,in a remote way, many biometric measurements such as: blood pressure, blood oxygenation, heart and respiratory rate

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All men and women aged \>= 65 years, resident in Salcito, a small mountain village in Molise region, Italy, will be invited to participate at the first examination, in order to evaluate their frailty condition, in a specific way their pre-frail/frail condition.

You may qualify if:

• Diagnosis of Pre-Frail;
• Salcito (a small mountain village in Molise region) residents.

You may not qualify if:

• Age\< 65 years;
• Individuals affected by physical or mental diseases, pacemaker or other medical device keeper who make the use of "wearable device" not possible or unable to complete functional tests.

Sponsors & Collaborators

• Neuromed IRCCS: lead
• University of Molise: collaborator

Study Sites (2)

IRCCS INM Neuromed, Department of Epidemiology and Prevention

Pozzilli, IS, 86077, Italy

Location

IRCCS Neuromed

Pozzilli, IS, 86077, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

During the baseline and follow-up visits (at 6 months), venous blood samples will be obtained by venipuncture from participants. Samples for this study will be analyzed to measure the general biochemical clinical parameters ( blood cells, inflammation biomarkers, lipid profile etc) and then they will be stored in straws containing the sample code and barcode in liquid nitrogen in a dedicated biobank at IRCCS NEUROMED.

MeSH Terms

Conditions

Frailty

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Licia Iacoviello, MD, PhD

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Epidemiology and Prevention

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 30, 2021
• Study Start: June 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IT (2)