NCT01608932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 28, 2015

Status Verified

May 1, 2012

Enrollment Period

2.1 years

First QC Date

May 29, 2012

Last Update Submit

October 27, 2015

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Number of emergency hospitalisations

    12 months

Secondary Outcomes (7)

  • Number of primary care visits.

    12 months

  • Health related quality of life as measured by the SF 36 version 2 questionnaire

    12 months

  • All cause mortality

    12 months

  • Number of visits to emergency department

    12 months

  • Number of elective hospital admissions

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Treatment as usual

Telemonitoring for frail patients with chronic diseases

EXPERIMENTAL

Telemonitoring for frail patients with chronic diseases

Procedure: Telemonitoring for frail patients with chronic diseases

Interventions

Telemonitoring for frail patients with chronic diseasesPROCEDURE

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.

Telemonitoring for frail patients with chronic diseases

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • Patient unable to use the telemonitoring equipment (alone and assisted)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Local Heath Authority of Padova

Padua, Padova, Italy

Location

Local Health Authority of Pieve di Soligo

Pieve di Soligo, Treviso, Italy

Location

Local Health Authority of Treviso

Treviso, Treviso, Italy

Location

Local Health Authority of Mirano

Mirano, Venezia, Italy

Location

Local Heath Authority Veneziana

Venezia, Venezia, Italy

Location

Local Heath Authority of Verona

Verona, Verona, Italy

Location

Local Heath Authority of Thiene

Thiene, Vicenza, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHeart Failure

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Nicolò Seminara, MD

    SIMG - LHA 9 of Treviso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2012

First Posted

May 31, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 28, 2015

Record last verified: 2012-05

Locations

IT(7)