DementiaPERFECTEDNCT03308123
PERFECTED: Caring for Patients With Hip-fracture & Memory Difficulties
An observational study of Dementia and Hip Fractures, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
This qualitative study is part of the 5-year long (2013-18) PERFECTED (Peri-operative Enhanced Recovery hip-fracture Care of paTiEnts with Dementia) National Institute for Health Research (NIHR) funded research programme. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Hip Fractures
- What is being tested?
- Observational study, not interventional
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2015to 22 Feb 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recently discharged (within a month) hip-fracture patients with mild memory difficulties
Who may be able to join
- A hip-fracture patient recently discharged (within a month) from an acute hospital in one of the study locations.
- 60 years or older
- Having some memory difficulties as recognised by a relevant member of their care team - supported by an AMT score of 5-8 if required
- Has the cognitive ability to engage with a research interview as determined by a relevant member of their care team
Who cannot join
- Lacks mental capacity
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of East Anglia
Norwich, Norfolk, NR4 7TJ
About this study
Official title: PERFECTED WP1 P4: A Qualitative Exploration of Lay and Professional Stakeholder Views of Care Delivery in Hospitals for Patients With Hip-fracture & Memory Difficulties
This qualitative study is part of the 5-year long (2013-18) PERFECTED (Peri-operative Enhanced Recovery hip-fracture Care of paTiEnts with Dementia) National Institute for Health Research (NIHR) funded research programme. PERFECTED's overall aim is to develop and pilot an evidence-based intervention to improve the hospital care of patients living with dementia who have fractured their hip. The findings from this particular study will support PERFECTED's other activities by exploring stakeholder (lay and professional) views of the hospital care experiences of hip-fracture patients who are experiencing memory difficulties. Best practices and priorities, including attention to cost-consequences will be explored.
Semi-structured interviews will be conducted with 15-30 hip-fracture patients with mild memory difficulties recently discharged from acute hospitals in Norwich, Nottingham and Bradford. Equal attention will be given to those patients discharged directly home and those discharged to community hospitals for further rehabilitation. Interviews will be conducted with 15-30 recognised carers of hip-fracture patients with moderate/severe memory difficulties who have recently been discharged from acute hospitals in the same three regions. Semi-structured interviews will also be carried out with a nominated dementia lead in each region. Finally, in each region, small focus groups, face-to-face or telephone interviews will be conducted, with clinical staff of various grades and professions, hospital managers and with NHS commissioners. This study will enable a range of topics and perspectives to be explored and potential components for PERFECTED's intervention to be identified.
As part of PERFECTED's on-going commitment to Public Patient Involvement (PPI), lay researchers will be trained to assist in interviewing recognised carers of hip-fracture patients with moderate/severe memory difficulties. Interviews and focus groups will be recorded, transcribed and analysed thematically. Resulting data will address the pre-defined aims of the current study and feed into findings reported across the whole of Work Package 1 of PERFECTED.
- Conditions
- Dementia, Hip Fractures
- Being tested
- Observational study, not interventional
- Medical subject headings
- Dementia, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, not interventionalOther
Not an intervention study
| Study group | Role | What they receive |
|---|---|---|
| Health Care Professionals | Health care professionals Receives: Other: Observational study, not interventional | |
| Carers of hip-fracture patients with moderate/severe | Carers of hip-fracture patients with moderate/severe Receives: Other: Observational study, not interventional | |
| Discharged hip-fracture patient with memory difficulty | Discharged hip-fracture patient with memory difficulty Receives: Other: Observational study, not interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-Structure Interview
Stakeholder experiences
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start1 Feb 2015
- Primary completion1 Jul 2015
- Study completion22 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George C Fox, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308123
- Sponsor's protocol ID
- 15/EE/0007
- Other IDs
- DTC-RP-PG-0311-12004
- Acronym
- PERFECTED
- Status last verified
- Aug 2017
- First submitted
- 9 Aug 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERFECTED WP1 P4: A Qualitative Exploration of Lay and Professional Stakeholder Views of Care Delivery in Hospitals for Patients With Hip-fracture & Memory Difficulties
- ClinicalTrials.gov ID
- NCT03308123
- Acronym / sponsor ID
- PERFECTED / 15/EE/0007
- Conditions
- Dementia, Hip Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 22 Feb 2016 (actual)
- First posted
- 12 Oct 2017 (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.
This qualitative study is part of the 5-year long (2013-18) PERFECTED (Peri-operative Enhanced Recovery hip-fracture Care of paTiEnts with Dementia) National Institute for Health Research (NIHR) funded research programme. PERFECTED's overall aim is to develop and pilot an evidence-based intervention to improve the hospital care of patients living with dementia who have fractured their hip. The findings from this particular study will support PERFECTED's other activities by exploring stakeholder (lay and professional) views of the hospital care experiences of hip-fracture patients who are experiencing memory difficulties. Best practices and priorities, including attention to cost-consequences will be explored.
Semi-structured interviews will be conducted with 15-30 hip-fracture patients with mild memory difficulties recently discharged from acute hospitals in Norwich, Nottingham and Bradford. Equal attention will be given to those patients discharged directly home and those discharged to community hospitals for further rehabilitation. Interviews will be conducted with 15-30 recognised carers of hip-fracture patients with moderate/severe memory difficulties who have recently been discharged from acute hospitals in the same three regions. Semi-structured interviews will also be carried out with a nominated dementia lead in each region. Finally, in each region, small focus groups, face-to-face or telephone interviews will be conducted, with clinical staff of various grades and professions, hospital managers and with NHS commissioners. This study will enable a range of topics and perspectives to be explored and potential components for PERFECTED's intervention to be identified.
As part of PERFECTED's on-going commitment to Public Patient Involvement (PPI), lay researchers will be trained to assist in interviewing recognised carers of hip-fracture patients with moderate/severe memory difficulties. Interviews and focus groups will be recorded, transcribed and analysed thematically. Resulting data will address the pre-defined aims of the current study and feed into findings reported across the whole of Work Package 1 of PERFECTED.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health Care Professionals | – | Other: Observational study, not interventionalHealth care professionals |
| Carers of hip-fracture patients with moderate/severe | – | Other: Observational study, not interventionalCarers of hip-fracture patients with moderate/severe |
| Discharged hip-fracture patient with memory difficulty | – | Other: Observational study, not interventionalDischarged hip-fracture patient with memory difficulty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recently discharged (within a month) hip-fracture patients with mild memory difficulties
Key inclusion criteria (4 listed)
- A hip-fracture patient recently discharged (within a month) from an acute hospital in one of the study locations.
- 60 years or older
- Having some memory difficulties as recognised by a relevant member of their care team - supported by an AMT score of 5-8 if required
- Has the cognitive ability to engage with a research interview as determined by a relevant member of their care team
Key exclusion criteria (1 listed)
- Lacks mental capacity
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 |
|---|---|---|
| Observational study, not interventionalNot an intervention study | Other | Carers of hip-fracture patients with moderate/severe, Discharged hip-fracture patient with memory difficulty, Health Care Professionals |
Primary outcome
Semi-Structure Interview
Time frame: 1 month
Stakeholder experiences
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 12 Oct 2017.
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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.
George C Fox principal investigator
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Hip Fractures, run by University of East Anglia at 1 site in United Kingdom.
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 4 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 12 Oct 2017. 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 United Kingdom. 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?
Semi-Structure Interview (time frame: 1 month). 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 12 Oct 2017.