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Life-long Monitoring of Frail Patients With Chronic Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01608932
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : October 28, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure Procedure: Telemonitoring for frail patients with chronic diseases

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: RENEWING HEALTH - Telemonitoring of Elderly and Frail Patients With Multiple Chronic Diseases in Veneto Region
Study Start Date : April 2012
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control Group
Treatment as usual
Experimental: Telemonitoring for frail patients with chronic diseases
Telemonitoring for frail patients with chronic diseases
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.

Outcome Measures

Primary Outcome Measures :
  1. Number of emergency hospitalisations [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of primary care visits. [ Time Frame: 12 months ]
  2. Health related quality of life as measured by the SF 36 version 2 questionnaire [ Time Frame: 12 months ]
  3. All cause mortality [ Time Frame: 12 months ]
  4. Number of visits to emergency department [ Time Frame: 12 months ]
  5. Number of elective hospital admissions [ Time Frame: 12 months ]
  6. Number of bed days for hospitalised patients [ Time Frame: 12 months ]
  7. Anxiety and depression status as measured by Hospital Anxiety and Depression Scale, HADS. [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608932

Local Health Authority of Pieve di Soligo
Pieve di Soligo, Treviso, Italy
Local Health Authority of Mirano
Mirano, Venezia, Italy
Local Heath Authority of Thiene
Thiene, Vicenza, Italy
Local Heath Authority of Padova
Padova, Italy
Local Health Authority of Treviso
Treviso, Italy
Local Heath Authority Veneziana
Venezia, Italy
Local Heath Authority of Verona
Verona, Italy
Sponsors and Collaborators
Regione Veneto
European Commission
Local Health Authorities n. 4
Local Health Authorities n. 7
Local Health Authorities n. 9
Local Health Authorities n. 12
Local Health Authorities n. 13
Local Health Authorities n. 16
Local Health Authorities n. 20
SIMG (Italian College of General Medicine)
Principal Investigator: Nicolò Seminara, MD SIMG - LHA 9 of Treviso
More Information

Responsible Party: Regione Veneto
ClinicalTrials.gov Identifier: NCT01608932     History of Changes
Other Study ID Numbers: G.A. 250487 - Veneto WP8Cl10
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: May 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Multiple Chronic Conditions
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes