Life-long Monitoring of Frail Patients With Chronic Diseases

Regione Veneto

Status

Completed

Conditions

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

Treatments

Procedure: Telemonitoring for frail patients with chronic diseases

Study type

Interventional

Funder types

Other

Identifiers

NCT01608932

G.A. 250487 - Veneto WP8Cl10

Details and patient eligibility

About

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.

Full 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.

Enrollment

152 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.