Life-long Monitoring of Frail Patients With Chronic Diseases
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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 Other: Control Group |
| 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 |
- Number of emergency hospitalisations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control Group
Treatment as usual
|
Other: Control Group
Participants in the control group receive usual care that is mainly management of the general practitioner and in part depending on the organisation of each local health authority. This kind of patients has regular outpatient visits and home visits according to their level of physical impairment. The visits frequency depends on the their health conditions. |
|
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 |
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| 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 | |
| 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: | June 8, 2012 |
| Health Authority: | Italy: Ethics Committee |
Additional relevant MeSH terms:
|
Chronic Disease Diabetes Mellitus Heart Failure Lung Diseases Respiration Disorders 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 May 16, 2013