Life-long Monitoring of Frail Patients With Chronic Diseases

Not Applicable

Completed

• Conditions: Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure
• Interventions: Procedure: Telemonitoring for frail patients with chronic diseases

• Registration Number: NCT01608932
• Lead Sponsor: Regione Veneto

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-04
• Status Verified: 2012-05
• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-31
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring for frail patients with chronic diseases	Telemonitoring for frail patients with chronic diseases	Telemonitoring for frail patients with chronic diseases

Primary Outcome Measures

Name	Time	Method
Number of emergency hospitalisations	12 months

Secondary Outcome Measures

Name	Time	Method
Number of bed days for hospitalised patients	12 months
Anxiety and depression status as measured by Hospital Anxiety and Depression Scale, HADS.	12 months
Number of primary care visits.	12 months
Health related quality of life as measured by the SF 36 version 2 questionnaire	12 months
All cause mortality	12 months
Number of visits to emergency department	12 months
Number of elective hospital admissions	12 months

Trial Locations

Locations (7)

Local Health Authority of Mirano; 🇮🇹 Mirano, Venezia, Italy

Local Heath Authority of Thiene; 🇮🇹 Thiene, Vicenza, Italy

Local Health Authority of Pieve di Soligo; 🇮🇹 Pieve di Soligo, Treviso, Italy

Local Health Authority of Treviso; 🇮🇹 Treviso, Italy

Local Heath Authority Veneziana; 🇮🇹 Venezia, Italy

Local Heath Authority of Padova; 🇮🇹 Padova, Italy

Local Heath Authority of Verona; 🇮🇹 Verona, Italy