Randomized Controlled Trial of Home Telemonitoring for Elderly People (Dreaming)

Health Information Management, Belgium

Status: Unknown

Conditions: Chronic Heart Failure; Chronic Obstructive Pulmonary Disease; Diabetes Mellitus

Treatments: Device: Wireless monitors for disease specific clinical parameters.

Study type: Interventional

Funder types: Other

Identifiers

NCT00893685

ICT support policy program

European Commission

Contract Number 225023

Details and patient eligibility

About

The DREAMING clinical trial is part of the DREAMING project, which has the objective to demonstrate that the DREAMING platform consisting of integrated health monitoring, alarm handling and videoconferencing services produces clinical benefits to its users and economic benefits to the health authorities. The study evaluates the long-term (30 months) effect of continuous use of the DREAMING subsystems and is testing the hypothesis that such use is superior to usual care alone in reducing the deterioration of health related quality of life that is associated to age and chronic disease. It also tests the hypothesis that the DREAMING environment is superior to usual care in delaying the transfer to nursing or elderly homes and in reducing the incidence and duration of hospitalisation episodes. The trial will also evaluate the cost-effectiveness of the DREAMING platform. Outcomes are assessed in six different health care systems (Denmark, Estonia, Germany, Italy, Spain and Sweden) and will represent a basis for the adoption of DREAMING services by the respective health authorities.

Full description

Homes of participants are equipped with environmental sensors, motion detection, and with wireless sensors for blood pressure, blood glucose, body weight, blood oxygen saturation, peak expiratory flow and electrocardiogram. Disease related parameters are monitored at least daily and the measured values are transmitted to a central monitoring unit. In case of abnormal values, health alarms are generated and transmitted to the local health authorities to trigger eventual intervention by the physicians and nurses who normally follow the participants. Participants and health professionals can stay in contact via an easy to use, home television based videoconferencing system. Participants are also equipped with a a personal alarm and GPS-enhanced localisation system.

Enrollment: 300 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion criteria:

• Diagnosis of chronic heart failure
• Diagnosis of diabetes mellitus
• Diagnosis of chronic obstructive pulmonary disease

Only in the case that the number of recruited participants is not sufficient, inclusion criteria can be extended to one or more of the following conditions:

• History of myocardial infarction
• History of stroke (brain ischemia or hemorrhage)
• History of falls within the last two years
• Hospitalization during the last two years (for every reason)

Exclusion criteria

• Not willing to participate (e.g non signing informed consent)
• Inability to use the DREAMING equipment
• Significant impairment of language comprehension or expression (aphasia)
• Diagnosis of dementia
• Completely dependent on others for the activities of daily living
• Living without access to ISDN or DSL service

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Home telemonitoring

Experimental group

Treatment:

Device: Wireless monitors for disease specific clinical parameters.

Usual care (control group)

No Intervention group