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Life-long Monitoring of Frail Patients With Chronic Diseases

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ClinicalTrials.gov Identifier: NCT01608932
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : October 28, 2015
Information provided by (Responsible Party):

May 29, 2012
May 31, 2012
October 28, 2015
April 2012
May 2014   (Final data collection date for primary outcome measure)
Number of emergency hospitalisations [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01608932 on ClinicalTrials.gov Archive Site
  • Number of primary care visits. [ Time Frame: 12 months ]
  • Health related quality of life as measured by the SF 36 version 2 questionnaire [ Time Frame: 12 months ]
  • All cause mortality [ Time Frame: 12 months ]
  • Number of visits to emergency department [ Time Frame: 12 months ]
  • Number of elective hospital admissions [ Time Frame: 12 months ]
  • Number of bed days for hospitalised patients [ Time Frame: 12 months ]
  • Anxiety and depression status as measured by Hospital Anxiety and Depression Scale, HADS. [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
Life-long Monitoring of Frail Patients With Chronic Diseases
RENEWING HEALTH - Telemonitoring of Elderly and Frail Patients With Multiple Chronic Diseases in Veneto Region
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.

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.

Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure
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.

  • No Intervention: Control Group
    Treatment as usual
  • Experimental: Telemonitoring for frail patients with chronic diseases
    Telemonitoring for frail patients with chronic diseases
    Intervention: Procedure: Telemonitoring for frail patients with chronic diseases
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2014
May 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
G.A. 250487 - Veneto WP8Cl10
Not Provided
Not Provided
Regione Veneto
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
Regione Veneto
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP