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NCT Number: NCT01608932

Life-long Monitoring of Frail Patients With Chronic Diseases

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.

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Key information

Conditions

Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure Cardiovascular Diseases Chronic Disease Disease Attributes Heart Diseases Heart Failure Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Local Heath Authority of Padova, Padova, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Telemonitoring for frail patients with chronic diseases

Procedure

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 outcomes

  1. Number of emergency hospitalisations

    Time frame: 12 months

Secondary outcomes

  1. Number of primary care visits.

    Time frame: 12 months

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

    Time frame: 12 months

  3. All cause mortality

    Time frame: 12 months

  4. Number of visits to emergency department

    Time frame: 12 months

  5. Number of elective hospital admissions

    Time frame: 12 months

  6. Number of bed days for hospitalised patients

    Time frame: 12 months

  7. Anxiety and depression status as measured by Hospital Anxiety and Depression Scale, HADS.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Regione Veneto

Other

Collaborators

  • European Commission
  • SIMG (Italian College of General Medicine)
  • The European Regional and Local Health Authorities

Registry information

Official study title

RENEWING HEALTH - Telemonitoring of Elderly and Frail Patients With Multiple Chronic Diseases in Veneto Region

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 31, 2012
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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