Randomized Controlled Trial of Home Telemonitoring for Elderly People

Diabetes Mellitus Clinical Trial

— Dreaming  

Official title:

Elderly Friendly Alarm Handling and Monitoring (DREAMING)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00893685
• Other study ID #: European Commission
• Secondary ID: European Commiss
• Status: Not yet recruiting
• Phase: N/A
• First received: April 22, 2009
• Last updated: May 7, 2009
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: May 2009
• Source: Health Information Management, Belgium
• Contact: Reinhard W Prior, M.D.
• Phone: +393341855067
• Email: rprior[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsEstonia: The State Agency of MedicineGermany: Ethics CommissionItaly: Ethics CommitteeSpain: Ethics CommitteeSweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Heart Failure
• Chronic Obstructive Pulmonary Disease
• Diabetes Mellitus
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Denmark	Langeland Municipality	Langeland
Estonia	East Tallin Central Hospital	Tallin
Germany	Pflegwerk Berlin, Mediplus	Berlin
Italy	Azienda per i Servizi Sanitari ASS N.1	Trieste
Spain	Servicio Aragones de Salud	Barbastro
Sweden	GP Surgery	Heby

Sponsors (1)

Lead Sponsor	Collaborator
Health Information Management, Belgium

Countries where clinical trial is conducted

Denmark,  Estonia,  Germany,  Italy,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life as assessed by the SF-36 questionnaire, at the beginning, at midterm and at the end of the trial period		0, 15, 30 months	No
Secondary	Time to permanent transfer to elderly homes		Measured at month 30	No
Secondary	Total and average length of stay in hospital		Measured at month 30	No
Secondary	Number of consultations with general practitioners		Measured at month 30	No
Secondary	Number of consultations with medical specialists		Measured at month 30	No
Secondary	Number of home visits by nurses		Measured at month 30	No
Secondary	Number of ambulance transports		Measured at month 30	No
Secondary	Number of accesses to emergency rooms		Measured at month 30	No
Secondary	Number of falls		Measured at month 30	No
Secondary	Number of femur fractures		Measured at month 30	No
Secondary	HbA1c change over time (only for participants with a diagnosis of diabetes)		Measured at month 30	No
Secondary	Survival		Measured at month 30	No
Secondary	Depression as measured by HADS		Measured at months 0, 15 and 30	No
Secondary	Number of hospitalisations		Measured at month 30	No
Secondary	Number of permanent transfers to elderly homes		Measured at month 30	No

External Links

•   DREAMING official project website