Life-long Monitoring of Frail Patients With Chronic Diseases

NCT01608932 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2015-10-28

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • European Commission

    collaborator OTHER
  • Local Health Authorities n. 4

    collaborator UNKNOWN
  • Local Health Authorities n. 7

    collaborator UNKNOWN
  • Local Health Authorities n. 9

    collaborator UNKNOWN
  • Local Health Authorities n. 12

    collaborator UNKNOWN
  • Local Health Authorities n. 13

    collaborator UNKNOWN
  • Local Health Authorities n. 16

    collaborator UNKNOWN
  • Local Health Authorities n. 20

    collaborator UNKNOWN
  • SIMG (Italian College of General Medicine)

    collaborator UNKNOWN
  • Regione Veneto

    lead OTHER

Principal Investigators

  • Nicolò Seminara, MD · SIMG - LHA 9 of Treviso

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01608932 on ClinicalTrials.gov