Randomized Controlled Trial of Home Telemonitoring for Elderly People

NCT ID: NCT00893685

Last Updated: 2009-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-12-31

Brief Summary

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.

Detailed 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.

Conditions

Diabetes Mellitus; Chronic Heart Failure; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Home telemonitoring

Group Type: EXPERIMENTAL

Wireless monitors for disease specific clinical parameters.

Intervention Type: DEVICE

Homes of participants will be equipped with wireless monitors for blood pressure, blood oxygen, blood glucose, peak expiratory flow, electrocardiogram, body weight. All vital parameters are monitored on a continuous, at least daily basis and obtained values are transmitted to a monitoring centre. Abnormal values are classified for their health risk and health alarms and/or intervention of health professionals is triggered.

Usual care (control group)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wireless monitors for disease specific clinical parameters.

Homes of participants will be equipped with wireless monitors for blood pressure, blood oxygen, blood glucose, peak expiratory flow, electrocardiogram, body weight. All vital parameters are monitored on a continuous, at least daily basis and obtained values are transmitted to a monitoring centre. Abnormal values are classified for their health risk and health alarms and/or intervention of health professionals is triggered.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Health Information Management, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Health Information Management Sa, Belgium

Principal Investigators

Reinhard W Prior, M.D.

Role: STUDY_DIRECTOR

Health Information Management, Brussels, Belgium

Helmut Prior, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute for Experimental Psychology, University of Düsseldorf, Germany (H.Prior is head of the data monitoring committee)

Locations

Langeland Municipality

Langeland, , Denmark

East Tallin Central Hospital

Tallinn, , Estonia

Pflegwerk Berlin, Mediplus

Berlin, , Germany

Azienda per i Servizi Sanitari ASS N.1

Trieste, , Italy

Servicio Aragones de Salud

Barbastro, , Spain

GP Surgery

Heby, , Sweden

Countries

Denmark; Estonia; Germany; Italy; Spain; Sweden

Central Contacts

Reinhard W Prior, M.D.

Role: CONTACT

rprior@gmail.com

+393341855067

Other Identifiers

European Commission

Identifier Type: -

Identifier Source: secondary_id

ICT support policy program

Identifier Type: -

Identifier Source: secondary_id

Contract Number 225023

Identifier Type: -

Identifier Source: secondary_id

European Commission

Identifier Type: -

Identifier Source: org_study_id