Clinical trial NCT01608932: Life-long Monitoring of Frail Patients With Chronic Diseases
Official title: RENEWING HEALTH - Telemonitoring of Elderly and Frail Patients With Multiple Chronic Diseases in Veneto Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure
Lead sponsor: Regione Veneto
Sponsor class: OTHER
Collaborators: name: European Commission
name: Local Health Authorities n. 4
name: Local Health Authorities n. 7
name: Local Health Authorities n. 9
name: Local Health Authorities n. 12
name: Local Health Authorities n. 13
name: Local Health Authorities n. 16
name: Local Health Authorities n. 20
name: SIMG (Italian College of General Medicine)
First posted: 2012-05-31
Enrollment: 152
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of emergency hospitalisations
timeFrame: 12 months
Secondary outcomes:
measure: Number of primary care visits.
timeFrame: 12 months
measure: Health related quality of life as measured by the SF 36 version 2 questionnaire
timeFrame: 12 months
measure: All cause mortality
timeFrame: 12 months
measure: Number of visits to emergency department
timeFrame: 12 months
measure: Number of elective hospital admissions
timeFrame: 12 months
measure: Number of bed days for hospitalised patients
timeFrame: 12 months
measure: Anxiety and depression status as measured by Hospital Anxiety and Depression Scale, HADS.
timeFrame: 12 months
Other outcomes:
Locations:
city: Pieve di Soligo
country: Italy
facility: Local Health Authority of Pieve di Soligo
state: Treviso
city: Mirano
country: Italy
facility: Local Health Authority of Mirano
state: Venezia
city: Thiene
country: Italy
facility: Local Heath Authority of Thiene
state: Vicenza
city: Padova
country: Italy
facility: Local Heath Authority of Padova
city: Treviso
country: Italy
facility: Local Health Authority of Treviso
city: Venezia
country: Italy
facility: Local Heath Authority Veneziana
city: Verona
country: Italy
facility: Local Heath Authority of Verona
Study officials:
affiliation: SIMG - LHA 9 of Treviso
name: Nicolò Seminara, MD
role: PRINCIPAL_INVESTIGATOR
References: