Evaluation of the Performance of an e-Health System

Air Liquide

Status: Terminated

Conditions: Chronic Diseases

Treatments: Device: medical device intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT02803489

ALMED-14-MD-051

Details and patient eligibility

About

Prospective, non-randomized, open-label, pilot study conducted in a single group of 30 evaluable patients, i.e. patients completing an approximate 3 month follow-up.

Full description

The eHealth system developed in the present study is dedicated to multimorbid patients' follow-up. The medical device consists in Telemonitoring, Telenotification and Telecoaching. It aims to both increase patient autonomy, with regard to management of his/her pathologies, and facilitate coordination between health professionals.

By providing patients with tools enabling early detection of clinical worsening combined with an appropriate management, the medium and long-term objectives are to reduce hospitalizations and improve health status and quality of life of these patients at home.

In the first instance, the only objective of the present study is to evaluate the performance and feasibility of implementation of the device. This evaluation is based on a comparison between the telenotifications generated by the software and those calculated from the raw data captured by the software.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients presenting all the following characteristics are eligible for inclusion:

1. Adult (>18 yrs), male or female
2. Presenting at least two chronic diseases among the following three: chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), diabetes
3. Having been hospitalized in the CHANGE or in any other medical care center (hospital or private clinic) for acute decompensation of CHF or exacerbation of COPD at least once during the 12 months prior to inclusion
4. Able to speak and understand French to a satisfactory standard
5. Having a phone land line
6. Capable of understanding and accepting the study constraints
7. Having signed a written informed consent after a full explanation of the study by the investigator prior to inclusion

Exclusion criteria

Patients presenting any one of the following characteristics are not eligible for inclusion:

1. Pregnant or breast-feeding woman
2. Institutionalized
3. Having a life expectancy of less than 3 months
4. Receiving or having received chemotherapy or radiotherapy for cancer within the past 6 months
5. Undergoing dialysis for chronic renal insufficiency
6. Presenting a condition likely to hamper accomplishment of the study procedures, such as chronic alcoholism, drug or solvent addiction, uncontrolled psychiatric disease or severe cognitive deficiency
7. Not covered by French Social Security
8. Participating or having participated in another interventional trial within the past 30 days

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

medical device intervention

Experimental group

Treatment:

Device: medical device intervention