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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Health Information Management, Belgium.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Health Information Management, Belgium
ClinicalTrials.gov Identifier:
NCT00893685
First received: April 22, 2009
Last updated: May 7, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Chronic Heart Failure
Chronic Obstructive Pulmonary Disease
Device: Wireless monitors for disease specific clinical parameters.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Elderly Friendly Alarm Handling and Monitoring (DREAMING)

Resource links provided by NLM:


Further study details as provided by Health Information Management, Belgium:

Primary Outcome Measures:
  • 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 [ Time Frame: 0, 15, 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to permanent transfer to elderly homes [ Time Frame: Measured at month 30 ] [ Designated as safety issue: No ]
  • Total and average length of stay in hospital [ Time Frame: Measured at month 30 ] [ Designated as safety issue: No ]
  • Number of consultations with general practitioners [ Time Frame: Measured at month 30 ] [ Designated as safety issue: No ]
  • Number of consultations with medical specialists [ Time Frame: Measured at month 30 ] [ Designated as safety issue: No ]
  • Number of home visits by nurses [ Time Frame: Measured at month 30 ] [ Designated as safety issue: No ]
  • Number of ambulance transports [ Time Frame: Measured at month 30 ] [ Designated as safety issue: No ]
  • Number of accesses to emergency rooms [ Time Frame: Measured at month 30 ] [ Designated as safety issue: No ]
  • Number of falls [ Time Frame: Measured at month 30 ] [ Designated as safety issue: No ]
  • Number of femur fractures [ Time Frame: Measured at month 30 ] [ Designated as safety issue: No ]
  • HbA1c change over time (only for participants with a diagnosis of diabetes) [ Time Frame: Measured at month 30 ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: Measured at month 30 ] [ Designated as safety issue: No ]
  • Depression as measured by HADS [ Time Frame: Measured at months 0, 15 and 30 ] [ Designated as safety issue: No ]
  • Number of hospitalisations [ Time Frame: Measured at month 30 ] [ Designated as safety issue: No ]
  • Number of permanent transfers to elderly homes [ Time Frame: Measured at month 30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: N.a.
No Intervention: Usual care (control group)

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893685

Contacts
Contact: Reinhard W Prior, M.D. +393341855067 rprior@gmail.com

Locations
Denmark
Langeland Municipality Enrolling by invitation
Langeland, Denmark, 5900
Estonia
East Tallin Central Hospital Enrolling by invitation
Tallin, Estonia, 10123
Germany
Pflegwerk Berlin, Mediplus Enrolling by invitation
Berlin, Germany, 10439
Italy
Azienda per i Servizi Sanitari ASS N.1 Enrolling by invitation
Trieste, Italy, 34128
Spain
Servicio Aragones de Salud Enrolling by invitation
Barbastro, Spain, 22300
Sweden
GP Surgery Enrolling by invitation
Heby, Sweden, 74432
Sponsors and Collaborators
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)
  More Information

Additional Information:
No publications provided

Responsible Party: Marco D'Angelantonio, Health Information Management Sa, Belgium
ClinicalTrials.gov Identifier: NCT00893685     History of Changes
Other Study ID Numbers: European Commission, European Commission, ICT support policy program, Contract Number 225023
Study First Received: April 22, 2009
Last Updated: May 7, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Estonia: The State Agency of Medicine
Germany: Ethics Commission
Italy: Ethics Committee
Spain: Ethics Committee
Sweden: Regional Ethical Review Board

Keywords provided by Health Information Management, Belgium:
Telemedicine

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 15, 2014