Life-long Monitoring of Frail Patients With Chronic Diseases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Regione Veneto.
Recruitment status was  Recruiting
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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: RENEWING HEALTH - Telemonitoring of Elderly and Frail Patients With Multiple Chronic Diseases in Veneto Region

Resource links provided by NLM:


Further study details as provided by Regione Veneto:

Primary Outcome Measures:
  • Number of emergency hospitalisations [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 152
Study Start Date: April 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608932

Locations
Italy
Local Health Authority of Pieve di Soligo Recruiting
Pieve di Soligo, Treviso, Italy
Contact: Maurizio Cancian, MD    0438/22536    cancian.maurizio@simg.it   
Principal Investigator: Maurizio Cancian, MD         
Local Health Authority of Mirano Recruiting
Mirano, Venezia, Italy
Contact: Roberto Zanibellato, MD    041 446790    rob.zani@tin.it   
Local Heath Authority of Thiene Recruiting
Thiene, Vicenza, Italy
Contact: Franco Cavallaro, MD    0445589050    fcavallaro@ulss4.veneto.it   
Local Heath Authority of Padova Recruiting
Padova, Italy
Contact: Bruno Franco Novelletto, MD    049702565    bnovel1@attglobal.net   
Local Health Authority of Treviso Recruiting
Treviso, Italy
Contact: Nicolò Seminara, MD    0422-967020    nseminara@libero.it   
Local Heath Authority Veneziana Recruiting
Venezia, Italy
Contact: Paola Bassetto, MD    041 5442405    pbassetto@libero.it   
Local Heath Authority of Verona Recruiting
Verona, Italy
Contact: Mario Celebrano, MD    0458349803    maceleb@tin.it   
Sponsors and Collaborators
Regione Veneto
European Commission - SIMG (Italian College of General Medicine) - Local Health Authorities n. 4 ,7 ,9 , 12, 13, 16, 20.
Investigators
Principal Investigator: Nicolò Seminara, MD SIMG - LHA 9 of Treviso
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01608932     History of Changes
Other Study ID Numbers: G.A. 250487 - Veneto WP8Cl10
Study First Received: May 29, 2012
Last Updated: January 21, 2014
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on August 20, 2014