Life-long Monitoring of Frail Patients With Chronic Diseases

This study is currently recruiting participants.
Verified May 2012 by Regione Veneto
Sponsor:
Collaborator:
European Commission - SIMG (Italian College of General Medicine) - Local Health Authorities n. 4 ,7 ,9 , 12, 13, 16, 20.
Information provided by:
Regione Veneto
ClinicalTrials.gov Identifier:
NCT01608932
First received: May 29, 2012
Last updated: January 21, 2014
Last verified: May 2012

May 29, 2012
January 21, 2014
April 2012
May 2014   (final data collection date for primary outcome measure)
Number of emergency hospitalisations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Health related quality of life as measured by the SF 36 version 2 questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of visits to emergency department [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of elective hospital admissions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of bed days for hospitalised patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Anxiety and depression status as measured by Hospital Anxiety and Depression Scale, HADS. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
152
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)
Both
65 Years and older
No
Not Provided
Italy
 
NCT01608932
G.A. 250487 - Veneto WP8Cl10
Yes
Not Provided
Regione Veneto
European Commission - SIMG (Italian College of General Medicine) - Local Health Authorities n. 4 ,7 ,9 , 12, 13, 16, 20.
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