Remote Monitoring to Prevent Frailty Progression in the Elderly

Frailty Clinical Trial

Official title:

Wearable Device Remote Monitoring to Prevent Frailty Progression in Elderly: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05173870
• Other study ID #: DEP_022021
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: Neuromed IRCCS
• Contact: Licia Iacoviello, MD, PhD
• Phone: +390865915247
• Email: licia.iacoviello[@]moli-sani.org; licia.iacoviello[@]neuromed.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Frailty is a condition of increased vulnerability to stressors due to age-related declines in physiologic reserves across neuromuscular, metabolic, and immune systems. It is considered a medical geriatric syndrome with multiple causes and contributors and it is characterized by diminished strength, power and endurance. In general, therefore, frailty is considered to be a multifactorial dysfunctional framework which includes the physical, psychological, cognitive, economic and social spheres and which leads to a serious deterioration in the quality of life. Due to the great impact of this condition on quality of life, developing interventions programs aiming to prevent the progression of frailty towards the independence loss, it is considered a key objective to support an healthy ageing.

In this context, the primary aim of the present pilot study is to standardize a study protocol to develop a useful model to enhance local care in small population isolates, by remotely monitoring the health status of pre-frail subjects and to improve the progression of the frailty condition, in order to support a healthy ageing for future investigation including a larger number of individuals.

Additional aims:

• To quantify the timeframes necessary for the subjects recruiting and examination activities,including questionnaires and functional tests administration;

• To quantify the training time needed to explain the use of the wearable device to the recruited elderly individuals;

• To assess the responsiveness of pre-frail subjects, during the preliminary screening, the examination visit and the monitoring period (follow-up 6 months);

• To evaluate the compliance of pre-frail individuals with the use of the wearable device.

All men and women aged >= 65 years, resident a small mountain village (Salcito) 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.

In the screening phase, in particular, it will be used the AGILE score to select the subjects to be included in the study. The questionnaire is a frailty tool that allows to quickly identify elderly, but also to investigate "multidimensional" frailty. It is built by selecting among the 40 items of the italian frailty index, the 10 ones most predictive of mortality. Therefore the questionnaire is composed by 10 items with a dychotomous answer (yes/no), in order to homogenously represent the four domains of frailty: physical, mental, nutrirional and socio-economic. After the preliminary screening, 30 elderly with pre-frailty will be randomly selected to be equipped with the wearable devices (such as smartband and smart-clothes ).The wearable devices have a biosensor able to daily collect,in a remote way, many biometric measurements such as: blood pressure, body temperature, heart and respiratory rate, posture and sleep quality.

During the baseline visit, the 30 pre-frail elderly will be trained to the use of the wearable devices. In addition, others questionnaires will be administered to collect information on their dietary habits, lifestyles, cognitive assessment and clinical history of the major chronic disease (CVD, cancer…). Additionally, during the baseline visit of recruited 30 pre-frail subjects, a venous blood sample will be collected. This will be used to measure biochemical and molecular parameters. In particular, samples will be analyzed to study potential biomarkers of pre-frailty/frailty condition. An aliquot of the biological sample will be stored in liquid nitrogen in a dedicated biobank of IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) NEUROMED, for any future molecular analysis.

Thanks to the wearable devices, individuals will be monitored constantly for six months, from a health point of view.

In the early stages of recruitment it will be possible to identify any critical issues in the training procedures of individuals over 65 recruited to use the wearable device.

During the six months period of monitoring, it will be possible to evaluate the compliance of subjects recruited to the wearable device use. In particular, it could be possible to evaluate the reliability of collected data thanks to the device and eventually make changes in operative procedures, when needed. If, during the monitoring, an abnormal parameter value will be observed, it will be communicated both to the subject and to his physician, with the aim of promoting a greater attention to personal health. In this way it could be possible to ensure a better quality of life. During six months, participants will be called back every other month, in order to evaluate the status of devices. After six months, participants will be called back for a follow-up visit, during which all the test, the questionnaires and the blood sample collection will be repeated to evaluate the potential impact of monitoring, on their condition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 31, 2024
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Pre-Frail;

• Salcito (a small mountain village in Molise region) residents.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Elderly
• Frailty

Intervention

Device:
• Wearable 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

Locations

Country	Name	City	State
Italy	IRCCS INM Neuromed, Department of Epidemiology and Prevention	Pozzilli	IS
Italy	IRCCS Neuromed	Pozzilli	IS

Sponsors (2)

Lead Sponsor	Collaborator
Neuromed IRCCS	University of Molise

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recruitment phase	This pilot study will be performed to quantify the timeframes necessary for the recruitment of the elderly subjects and for the examination activities, including questionnaires and functional tests administration.	From February 2022 to May 2022
Secondary	Training Phase	This pilot study will be performed to quantify the training time needed to explain the use the wearable device to the recruited elderly individuals.	From February 2022 to May 2022
Secondary	Pre-frail subjects responsiveness	This pilot study want to assess the responsiveness (i.e.the active participation to the project) of pre-frail subjects.; This aspect will be evaluated as follows: Affirmative response to the invitation to the screeening visit; Active participation and complete all the questionnaires during the examination visit; Collaboration and interactions with the researchers during the monitoring period (follow-up 6 months).	From February 2022 to August 2022
Secondary	Wearable device compliance	This pilot study want to evaluate the compliance of pre-frail individuals with the use of the wearable device.; This aspect will be evaluated by monitoring the time during which subjects wear the device.; If it is weared less than 5 days (20/24h) per week, it will be considered as a low compliance.	From February 2022 to August 2022