Clinical trial NCT00893685: Randomized Controlled Trial of Home Telemonitoring for Elderly People
Official title: Elderly Friendly Alarm Handling and Monitoring (DREAMING)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Chronic Heart Failure
Chronic Obstructive Pulmonary Disease
Keywords: Telemedicine
Lead sponsor: Health Information Management, Belgium
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 0, 15, 30 months
Secondary outcomes:
measure: Time to permanent transfer to elderly homes
timeFrame: Measured at month 30
measure: Total and average length of stay in hospital
timeFrame: Measured at month 30
measure: Number of consultations with general practitioners
timeFrame: Measured at month 30
measure: Number of consultations with medical specialists
timeFrame: Measured at month 30
measure: Number of home visits by nurses
timeFrame: Measured at month 30
measure: Number of ambulance transports
timeFrame: Measured at month 30
measure: Number of accesses to emergency rooms
timeFrame: Measured at month 30
measure: Number of falls
timeFrame: Measured at month 30
measure: Number of femur fractures
timeFrame: Measured at month 30
measure: HbA1c change over time (only for participants with a diagnosis of diabetes)
timeFrame: Measured at month 30
measure: Survival
timeFrame: Measured at month 30
measure: Depression as measured by HADS
timeFrame: Measured at months 0, 15 and 30
measure: Number of hospitalisations
timeFrame: Measured at month 30
measure: Number of permanent transfers to elderly homes
timeFrame: Measured at month 30
Other outcomes:
Locations:
city: Langeland
country: Denmark
facility: Langeland Municipality
city: Tallin
country: Estonia
facility: East Tallin Central Hospital
city: Berlin
country: Germany
facility: Pflegwerk Berlin, Mediplus
city: Trieste
country: Italy
facility: Azienda per i Servizi Sanitari ASS N.1
city: Barbastro
country: Spain
facility: Servicio Aragones de Salud
city: Heby
country: Sweden
facility: GP Surgery
Study officials:
affiliation: Health Information Management, Brussels, Belgium
name: Reinhard W Prior, M.D.
role: STUDY_DIRECTOR
affiliation: Institute for Experimental Psychology, University of Düsseldorf, Germany (H.Prior is head of the data monitoring committee)
name: Helmut Prior, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: