Life-long Monitoring of Frail Patients With Chronic Diseases

Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure Clinical Trial

Official title:

RENEWING HEALTH - Telemonitoring of Elderly and Frail Patients With Multiple Chronic Diseases in Veneto Region

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608932
• Other study ID #: G.A. 250487 - Veneto WP8Cl10
• Status: Completed
• Phase: N/A
• First received: May 29, 2012
• Last updated: October 27, 2015
• Start date: April 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2012
• Source: Regione Veneto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether telemonitoring of frail patients with chronic diseases produces benefits in terms of reduced readmissions, improved health related quality of life, and improved health status. In addition, the trial evaluates the economic and organisational impact of the telemonitoring service and examines its acceptability by patients and health professionals.

Description:

The study is designed to evaluate the impact of telemonitoring on the follow-up of elderly patients with one or more chronic diseases among heart failure, chronic obstructive pulmonary disease and diabetes. The particular target of patients selected has the particularity of being "frail" according to a set of social eligibility criteria, agreed by the clinicians participating at the study. General practitioners are the first clinicians in charge of managing these patients during the trial follow-up. The term of comparison is represented by a control group, followed by outpatient usual care.

From a clinical point of view, the trial will investigate how the remote monitoring of some clinical parameters contributes to reduce the access to healthcare facilities (emergency and planned hospitalization, bed-days, ER, specialist and GP visits), to improve the patients health-related quality of life and to reduce the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age = 65 years

• Diagnosis of one or more of the following chronic diseases:

• Heart failure - diagnosis confirmed by echocardiogram or by a specialist assessment

• Type 1 or 2 diabetes - with HbA1C of 7.5 or greater in the previous 15 months

• Chronic Obstructive Pulmonary Disease (COPD) - diagnosis confirmed by spirometry and FEV1 = 70% of predicted normal and/or FEV1/FVC ratio = 70% or by a specialist assessment

• and at least one of the following Social inclusion criteria:

• Have had a fall in the previous year or who are considered at high risk of falling

• Need home social care

• Have a caregiver who have difficulties to take care of him/her properly

• Cognitive impairment/confusion, but with caregiver able to use devices.

Exclusion Criteria:

• Patient unable to use the telemonitoring equipment (alone and assisted)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases, Obstructive
• Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Telemonitoring for frail patients with chronic diseases
Patients are equipped with a telemonitoring kit that can be composed by a portable wrist clinic device, a digital weight scale and a glucometer for clinical parameters measuring, according to the pathologies of the patient. The equipment is completed by a gateway device for data transmission. The patient can monitor a complete set of clinical parameters, such as pulse-oxymetry, heart rate, blood pressure, ECG, body weight and glycemia with a frequency set by the clinician in the personalized treatment plan. In the same protocol the clinician includes also the alarm thresholds that determine when the clinical measures are out-of-range. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alerts the general practitioner in case of worsening of symptoms.

Locations

Country	Name	City	State
Italy	Local Health Authority of Mirano	Mirano	Venezia
Italy	Local Heath Authority of Padova	Padova
Italy	Local Health Authority of Pieve di Soligo	Pieve di Soligo	Treviso
Italy	Local Heath Authority of Thiene	Thiene	Vicenza
Italy	Local Health Authority of Treviso	Treviso
Italy	Local Heath Authority Veneziana	Venezia
Italy	Local Heath Authority of Verona	Verona

Sponsors (10)

Lead Sponsor	Collaborator
Regione Veneto	European Commission, Local Health Authorities n. 12, Local Health Authorities n. 13, Local Health Authorities n. 16, Local Health Authorities n. 20, Local Health Authorities n. 4, Local Health Authorities n. 7, Local Health Authorities n. 9, SIMG (Italian College of General Medicine)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of emergency hospitalisations		12 months	No
Secondary	Number of primary care visits.		12 months	No
Secondary	Health related quality of life as measured by the SF 36 version 2 questionnaire		12 months	No
Secondary	All cause mortality		12 months	No
Secondary	Number of visits to emergency department		12 months	No
Secondary	Number of elective hospital admissions		12 months	No
Secondary	Number of bed days for hospitalised patients		12 months	No
Secondary	Anxiety and depression status as measured by Hospital Anxiety and Depression Scale, HADS.		12 months	No