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

Elderly Friendly Alarm Handling and Monitoring (DREAMING)

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus; Chronic Obstructive Pulmonary Disease; Chronic Heart Failure
• Intervention / Treatment: Device: Wireless monitors for disease specific clinical parameters.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Langeland, Denmark, 5900
    • Langeland Municipality
• Estonia
  • Tallin, Estonia, 10123
    • East Tallin Central Hospital
• Germany
  • Berlin, Germany, 10439
    • Pflegwerk Berlin, Mediplus
• Italy
  • Trieste, Italy, 34128
    • Azienda per i Servizi Sanitari ASS N.1
• Spain
  • Barbastro, Spain, 22300
    • Servicio Aragones De Salud
• Sweden
  • Heby, Sweden, 74432
    • GP Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home telemonitoring	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.
No Intervention: Usual care (control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to permanent transfer to elderly homes	Measured at month 30
Total and average length of stay in hospital	Measured at month 30
Number of consultations with general practitioners	Measured at month 30
Number of consultations with medical specialists	Measured at month 30
Number of home visits by nurses	Measured at month 30
Number of ambulance transports	Measured at month 30
Number of accesses to emergency rooms	Measured at month 30
Number of falls	Measured at month 30
Number of femur fractures	Measured at month 30
HbA1c change over time (only for participants with a diagnosis of diabetes)	Measured at month 30
Survival	Measured at month 30
Depression as measured by HADS	Measured at months 0, 15 and 30
Number of hospitalisations	Measured at month 30
Number of permanent transfers to elderly homes	Measured at month 30

Collaborators and Investigators

• Sponsor: Health Information Management, Belgium
• Investigators: Study Director: Reinhard W Prior, M.D., Health Information Management, Brussels, Belgium; Principal Investigator: Helmut Prior, Prof. Dr., Institute for Experimental Psychology, University of Düsseldorf, Germany (H.Prior is head of the data monitoring committee)

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): November 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: April 22, 2009
• First Submitted That Met QC Criteria: May 5, 2009
• First Posted (Estimate): May 6, 2009

Study Record Updates

• Last Update Posted (Estimate): May 8, 2009
• Last Update Submitted That Met QC Criteria: May 7, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Telemedicine
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: European Commission (Other Grant/Funding Number: Horizon EU Grant Agreement 101080323); ICT support policy program; Contract Number 225023