Diabetes MellitusDreamingNCT00893685
Randomized Controlled Trial of Home Telemonitoring for Elderly People
A study testing Wireless monitors for disease specific clinical parameters. in people with Diabetes Mellitus and Chronic Heart Failure, run by Health Information Management, Belgium at 6 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Chronic Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Wireless monitors for disease specific clinical parameters.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 6 sitesin 6 countries
- Study dates
- May 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: 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.
Read the 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.
- Being tested
- Wireless monitors for disease specific clinical parameters.
- Keywords
- Telemedicine
- Medical subject headings
- Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless monitors for disease specific clinical parameters.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.
| Study group | Role | What they receive |
|---|---|---|
| Home telemonitoring | Experimental | Not described Receives: Device: Wireless monitors for disease specific clinical parameters. |
| Usual care (control group) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0, 15, 30 months
Secondary outcomes (14)
Time to permanent transfer to elderly homes
Measured: Measured at month 30
Total and average length of stay in hospital
Measured: Measured at month 30
Number of consultations with general practitioners
Measured: Measured at month 30
Number of consultations with medical specialists
Measured: Measured at month 30
Number of home visits by nurses
Measured: Measured at month 30
Number of ambulance transports
Measured: Measured at month 30
Number of accesses to emergency rooms
Measured: Measured at month 30
Number of falls
Measured: Measured at month 30
Number of femur fractures
Measured: Measured at month 30
HbA1c change over time (only for participants with a diagnosis of diabetes)
Measured: Measured at month 30
Survival
Measured: Measured at month 30
Depression as measured by HADS
Measured: Measured at months 0, 15 and 30
Number of hospitalisations
Measured: Measured at month 30
Number of permanent transfers to elderly homes
Measured: Measured at month 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Information Management, Belgium
- Sponsor type
- University, hospital or other
- Investigators
- Reinhard W Prior, M.D., Study director, Health Information Management, Brussels, BelgiumHelmut Prior, Prof. Dr., Principal investigator, Institute for Experimental Psychology, University of Düsseldorf, Germany (H.Prior is head of the data monitoring committee)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893685
- Sponsor's protocol ID
- European Commission
- Other IDs
- European Commission, ICT support policy program, Contract Number 225023
- Acronym
- Dreaming
- Status last verified
- May 2009
- First submitted
- 22 Apr 2009
- Last updated
- 8 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elderly Friendly Alarm Handling and Monitoring (DREAMING)
- ClinicalTrials.gov ID
- NCT00893685
- Acronym / sponsor ID
- Dreaming / European Commission
- Keywords
- Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Health Information Management, BelgiumUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 6 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home telemonitoring | Experimental | Device: Wireless monitors for disease specific clinical parameters. |
| Usual care (control group) | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Home telemonitoring |
Primary outcome
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
14 secondary outcomes
Time to permanent transfer to elderly homes
Time frame: Measured at month 30
Total and average length of stay in hospital
Time frame: Measured at month 30
Number of consultations with general practitioners
Time frame: Measured at month 30
Number of consultations with medical specialists
Time frame: Measured at month 30
Number of home visits by nurses
Time frame: Measured at month 30
Number of ambulance transports
Time frame: Measured at month 30
Number of accesses to emergency rooms
Time frame: Measured at month 30
Number of falls
Time frame: Measured at month 30
Number of femur fractures
Time frame: Measured at month 30
HbA1c change over time (only for participants with a diagnosis of diabetes)
Time frame: Measured at month 30
Survival
Time frame: Measured at month 30
Depression as measured by HADS
Time frame: Measured at months 0, 15 and 30
Number of hospitalisations
Time frame: Measured at month 30
Number of permanent transfers to elderly homes
Time frame: Measured at month 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reinhard W Prior, M.D. study director
Health Information Management, Brussels, Belgium
Helmut Prior, Prof. Dr. principal investigator
Institute for Experimental Psychology, University of Düsseldorf, Germany (H.Prior is head of the data monitoring committee)
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wireless monitors for disease specific clinical parameters. in people with Diabetes Mellitus and Chronic Heart Failure, run by Health Information Management, Belgium at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark, Estonia, Germany, Italy, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reinhard W Prior, M.D. (+393341855067, rprior@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 0, 15, 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2009.