DeliriumNCT03470662
Prevention of Delirium Among Elderly Patients With Hip Fractures
A study testing Care bundle in people with Delirium and Hip Fractures, run by Zhoupu Hospital, Pudong New Area, Shanghai, China at 1 site in China.
Trial summary
Objective: To evaluate the effect of care bundle on prevention of delirium among elderly patients with hip fractures. Methods: A prospective randomized case control study was performed for 80 patients (≥65 years) with hip fractures treated surgically according to their ages and the type of fractures from March 1th of… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Hip Fractures
- What is being tested?
- Care bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 30 Sep 2017
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- ≥65 years
- with hip fractures
- treated surgically
Who cannot join
- <65 years
- psychiatric history
- ICU post-operation
- refuse to join this study
- have delirium pre-operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prospective Care Bundle on Prevention of Delirium Among Elderly Patients With Hip Fractures
Objective: To evaluate the effect of care bundle on prevention of delirium among elderly patients with hip fractures.
Methods: A prospective randomized case control study was performed for 80 patients (≥65 years) with hip fractures treated surgically according to their ages and the type of fractures from March 1th of 2017 to June 30th of 2017．There were 11 males and 69 females, with the age of (79.3±7.84) years. Confusion assessment method (CAM) was applied to diagnose delirium after surgery, the subjects were randomized divided into experimental group (n=43) and control group (n=37). The parameters next were recorded and analyzed, including age, gender, type of fractures, type of internal instrument, amount of bleeding, time between injured to surgery, time length of operation, type of operation, VAS, incidence of delirium, perioperative complications and adverse events.
- Conditions
- Delirium, Hip Fractures
- Being tested
- Care bundle
- Keywords
- Hip fractures, Delirium, Aged, Care bundle
- Medical subject headings
- Delirium, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care bundleOther
Care bundle
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Care bundle Receives: Other: Care bundle |
| control group | No intervention | routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of delirium among elderly patients with hip fractures
study hypothesis: the incidence of delirium postoperatively in experimental group is lower compared with control group
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Mar 2017
- Primary completion30 Jun 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhoupu Hospital, Pudong New Area, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoxiao Zhou, Zhoupu Hospital, Pudong New Area, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470662
- Sponsor's protocol ID
- YuFengbinDelirium
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prospective Care Bundle on Prevention of Delirium Among Elderly Patients With Hip Fractures
- ClinicalTrials.gov ID
- NCT03470662
- Acronym / sponsor ID
- YuFengbinDelirium
- Conditions
- Delirium, Hip Fractures
- Keywords
- Hip fractures, Delirium, Aged, Care bundle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zhoupu Hospital, Pudong New Area, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 20 Mar 2018 (actual)
- 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.
Objective: To evaluate the effect of care bundle on prevention of delirium among elderly patients with hip fractures.
Methods: A prospective randomized case control study was performed for 80 patients (≥65 years) with hip fractures treated surgically according to their ages and the type of fractures from March 1th of 2017 to June 30th of 2017．There were 11 males and 69 females, with the age of (79.3±7.84) years. Confusion assessment method (CAM) was applied to diagnose delirium after surgery, the subjects were randomized divided into experimental group (n=43) and control group (n=37). The parameters next were recorded and analyzed, including age, gender, type of fractures, type of internal instrument, amount of bleeding, time between injured to surgery, time length of operation, type of operation, VAS, incidence of delirium, perioperative complications and adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Care bundleCare bundle |
| control group | No intervention | –routine care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ≥65 years
- with hip fractures
- treated surgically
Key exclusion criteria (5 listed)
- <65 years
- psychiatric history
- ICU post-operation
- refuse to join this study
- have delirium pre-operation
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 |
|---|---|---|
| Care bundleCare bundle | Other | experimental group |
Primary outcome
incidence of delirium among elderly patients with hip fractures
Time frame: 3 weeks
study hypothesis: the incidence of delirium postoperatively in experimental group is lower compared with control group
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 20 Mar 2018.
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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 Care bundle in people with Delirium and Hip Fractures, run by Zhoupu Hospital, Pudong New Area, Shanghai, China at 1 site in China.
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 3 inclusion and 5 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 20 Mar 2018. 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 China. 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?
incidence of delirium among elderly patients with hip fractures (time frame: 3 weeks). 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 20 Mar 2018.