Elderly PeopleNCT01839825
Comparative Study of QuietCare
A study testing QuietCare in people with Elderly People and Living Alone in a Residence With Care Giver, run by National Center for Geriatrics and Gerontology, Japan at 1 site in Japan.
Trial summary
The objective of the study is to examine the efficacy and safety of QuietCare in a randomized, open study in elderly subjects living in assisted/ independent living facilities for 6 months. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly People, Living Alone in a Residence With Care Giver
- What is being tested?
- QuietCare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2012to Jul 2013
- 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
- ability to move independently or by using a walker (without assistance) inside
- residents using a single room, age 65 or older, of either sex
Who cannot join
- people who use wheel chairs,
- people who are bed-ridden
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparative Study of QuietCare (Motion Sensor System) in Elderly Subjects Living in Assisted/ Independent Living Facilities
The objective of the study is to examine the efficacy and safety of QuietCare in a randomized, open study in elderly subjects living in assisted/ independent living facilities for 6 months.
- Being tested
- QuietCare
- Keywords
- elderly, fall, acute illness, care giver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuietCareDevice
Also called passive monitoring system using infrared
| Study group | Role | What they receive |
|---|---|---|
| QuietCare | Experimental | QuieCare system installed Receives: Device: QuietCare |
| control | No intervention | no system installed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in score of Care Service Quetionnaire
- improvement in care level assessment
- improvement in care plannning
- improvement in communication among staff
- improvement in communication with residents and their family
Measured: The observation period is 6 months.
Time required for staff to respond to events
Measured: The observation period is 6 months.
Incidence of falls
Measured: The observation period is 6 months
Secondary outcomes (1)
Fee for medical and nursing care treatments
Measured: The observation period is 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PeopleStudies 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Geriatrics and Gerontology, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Takayuki Hosoi, National Center for Geriatrics and Gerontology, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839825
- Sponsor's protocol ID
- 109-2012-GES-0001
- Status last verified
- Sep 2014
- First submitted
- 30 Mar 2013
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparative Study of QuietCare (Motion Sensor System) in Elderly Subjects Living in Assisted/ Independent Living Facilities
- ClinicalTrials.gov ID
- NCT01839825
- Acronym / sponsor ID
- 109-2012-GES-0001
- Keywords
- elderly, fall, acute illness, care giver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- National Center for Geriatrics and Gerontology, JapanUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 25 Apr 2013 (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 objective of the study is to examine the efficacy and safety of QuietCare in a randomized, open study in elderly subjects living in assisted/ independent living facilities for 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QuietCare | Experimental | Device: QuietCareQuieCare system installed |
| control | No intervention | –no system installed |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- ability to move independently or by using a walker (without assistance) inside
- residents using a single room, age 65 or older, of either sex
Key exclusion criteria (2 listed)
- people who use wheel chairs,
- people who are bed-ridden
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 |
|---|---|---|
| QuietCareAlso: passive monitoring system using infrared | Device | QuietCare |
Primary outcome
Changes in score of Care Service Quetionnaire
Time frame: The observation period is 6 months.
* improvement in care level assessment * improvement in care plannning * improvement in communication among staff * improvement in communication with residents and their family
Time required for staff to respond to events
Time frame: The observation period is 6 months.
Incidence of falls
Time frame: The observation period is 6 months
1 secondary outcome
Fee for medical and nursing care treatments
Time frame: The observation period is 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QuietCare in people with Elderly People and Living Alone in a Residence With Care Giver, run by National Center for Geriatrics and Gerontology, Japan at 1 site in Japan.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 26 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in score of Care Service Quetionnaire (time frame: The observation period is 6 months.). The study lists 3 primary outcomes in all. 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 26 Sep 2014.