Pressure UlcersPhase 2/3TEAMNCT01008254
Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers
A Phase 2/3 study testing Musical prompt, Delayed musical prompt and No musical prompt in people with Pressure Ulcers, run by University of Cincinnati.
Trial summary
Musical reminder will raise compliance with mobility in the long-term care setting and reduce facility-acquired pressure ulcers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- Musical prompt, Delayed musical prompt and No musical prompt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to May 2011
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Long-term care resident
- MDS qualified
Who cannot join
- Self pay long-term care residents
About this study
Musical reminder will raise compliance with mobility in the long-term care setting and reduce facility-acquired pressure ulcers.
- Conditions
- Pressure Ulcers
- Being tested
- Musical prompt, Delayed musical prompt, No musical prompt
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical promptBehavioural
Repositioning and mobility education program administered to all facility staff combined with tailored musical prompt reminder that played every two hours, every day, during a 12 hour period, for 12 months.
Delayed musical promptBehavioural
Repositioning and mobility education program administered to all facility staff combined with tailored musical prompt reminder that played every two hours, every day, during a 12 hour period, for 6 months.
No musical promptOther
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Musical prompt | Experimental | Not described Receives: Behavioral: Musical prompt |
| Delayed musical prompt | Active comparator | Not described Receives: Behavioral: Delayed musical prompt |
| No musical prompt | No intervention | Not described Receives: Other: No musical prompt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Facility Acquired Pressure Ulcers
Measured: 2 years
Secondary outcomes (1)
Organizational Change
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Tracey L. Yap, University of Cincinnati
- Investigators
- Tracey L Yap, RN, PhD, Principal investigator, University of Cincinnati College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008254
- Sponsor's protocol ID
- #1007523
- Acronym
- TEAM
- Status last verified
- Oct 2011
- First submitted
- 4 Nov 2009
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yap TL, Kennerly SM, Simmons MR, Buncher CR, Miller E, Kim J, Yap WY. Multidimensional team-based intervention using musical cues to reduce odds of facility-acquired pressure ulcers in long-term care: a paired randomized intervention study. J Am Geriatr Soc. 2013 Sep;61(9):1552-9. doi: 10.1111/jgs.12422. Epub 2013 Aug 26.
PubMed 24028358
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers
- ClinicalTrials.gov ID
- NCT01008254
- Acronym / sponsor ID
- TEAM / #1007523
- Conditions
- Pressure Ulcers
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Sep 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 5 Nov 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.
Musical reminder will raise compliance with mobility in the long-term care setting and reduce facility-acquired pressure ulcers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Musical prompt | Experimental | Behavioral: Musical prompt |
| Delayed musical prompt | Active comparator | Behavioral: Delayed musical prompt |
| No musical prompt | No intervention | Other: No musical prompt |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Long-term care resident
- MDS qualified
Key exclusion criteria (1 listed)
- Self pay long-term care residents
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 |
|---|---|---|
| Musical promptRepositioning and mobility education program administered to all facility staff combined with tailored musical prompt reminder that played every two hours, every day, during a 12 hour period, for 12 months. | Behavioural | Musical prompt |
| Delayed musical promptRepositioning and mobility education program administered to all facility staff combined with tailored musical prompt reminder that played every two hours, every day, during a 12 hour period, for 6 months. | Behavioural | Delayed musical prompt |
| No musical promptNo intervention. | Other | No musical prompt |
Primary outcome
Reduction of Facility Acquired Pressure Ulcers
Time frame: 2 years
1 secondary outcome
Organizational Change
Time frame: 2 years
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 19 Oct 2011.
- Derived from this study: PubMed 24028358Yap TL, Kennerly SM, Simmons MR, Buncher CR, Miller E, Kim J, Yap WY. Multidimensional team-based intervention using musical cues to reduce odds of facility-acquired pressure ulcers in long-term care: a paired randomized intervention study. J Am Geriatr Soc. 2013 Sep;61(9):1552-9. doi: 10.1111/jgs.12422. Epub 2013 Aug 26.
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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.
Tracey L Yap, RN, PhD principal investigator
University of Cincinnati College of Nursing
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Musical prompt, Delayed musical prompt and No musical prompt in people with Pressure Ulcers, run by University of Cincinnati.
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 1 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 19 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction of Facility Acquired Pressure Ulcers (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01008254, which also lists 1 linked publication.
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 19 Oct 2011.