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Life-long Monitoring of Frail Patients With Chronic Diseases

Primary Purpose

Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Telemonitoring for frail patients with chronic diseases
Sponsored by
Regione Veneto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Local Health Authority of Pieve di Soligo
  • Local Health Authority of Mirano
  • Local Heath Authority of Thiene
  • Local Heath Authority of Padova
  • Local Health Authority of Treviso
  • Local Heath Authority Veneziana
  • Local Heath Authority of Verona

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Telemonitoring for frail patients with chronic diseases

Arm Description

Treatment as usual

Telemonitoring for frail patients with chronic diseases

Outcomes

Primary Outcome Measures

Number of emergency hospitalisations

Secondary Outcome Measures

Number of primary care visits.
Health related quality of life as measured by the SF 36 version 2 questionnaire
All cause mortality
Number of visits to emergency department
Number of elective hospital admissions
Number of bed days for hospitalised patients
Anxiety and depression status as measured by Hospital Anxiety and Depression Scale, HADS.

Full Information

First Posted
May 29, 2012
Last Updated
October 27, 2015
Sponsor
Regione Veneto
Collaborators
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)
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1. Study Identification

Unique Protocol Identification Number
NCT01608932
Brief Title
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

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regione Veneto
Collaborators
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)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Treatment as usual
Arm Title
Telemonitoring for frail patients with chronic diseases
Arm Type
Experimental
Arm Description
Telemonitoring for frail patients with chronic diseases
Intervention Type
Procedure
Intervention Name(s)
Telemonitoring for frail patients with chronic diseases
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of emergency hospitalisations
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of primary care visits.
Time Frame
12 months
Title
Health related quality of life as measured by the SF 36 version 2 questionnaire
Time Frame
12 months
Title
All cause mortality
Time Frame
12 months
Title
Number of visits to emergency department
Time Frame
12 months
Title
Number of elective hospital admissions
Time Frame
12 months
Title
Number of bed days for hospitalised patients
Time Frame
12 months
Title
Anxiety and depression status as measured by Hospital Anxiety and Depression Scale, HADS.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolò Seminara, MD
Organizational Affiliation
SIMG - LHA 9 of Treviso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Local Health Authority of Pieve di Soligo
City
Pieve di Soligo
State/Province
Treviso
Country
Italy
Facility Name
Local Health Authority of Mirano
City
Mirano
State/Province
Venezia
Country
Italy
Facility Name
Local Heath Authority of Thiene
City
Thiene
State/Province
Vicenza
Country
Italy
Facility Name
Local Heath Authority of Padova
City
Padova
Country
Italy
Facility Name
Local Health Authority of Treviso
City
Treviso
Country
Italy
Facility Name
Local Heath Authority Veneziana
City
Venezia
Country
Italy
Facility Name
Local Heath Authority of Verona
City
Verona
Country
Italy

12. IPD Sharing Statement

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Life-long Monitoring of Frail Patients With Chronic Diseases

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