FrailtyCONtrolNCT04503811
Sense of Control in Frail Older Persons
An observational study of Frailty and Older People, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
The proposed study seeks to explore the lived experience of control and wellbeing of older people diagnosed with frailty within the care service provision in southern England. In the study, the researcher will talk with older people diagnosed with frailty and the professionals that provide care to them. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Older People, Sense of Control
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2021to 21 Feb 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study will focus on frail older people and Day Hospital staff that provide care to them.
Who may be able to join
- Phase one inclusion criteria (frail older people) The pre-selected inclusion criteria for this category of participants include;
- older people (aged 65 years and over);
- individuals diagnosed with frailty and receiving (part of their) care services at the Day Hospital;
- the capacity to give free and fully informed consent;
- ability to use the English language, as well as judgement by the clinical staff and/or nominated manager that the potential participant can take part in an in-depth interview.
- Phase two inclusion criteria (Hospital staff)
- The study will include staff that routinely work with frail older people at the Day Hospital including nurses (registered and unregistered), doctors, physiotherapists, occupational therapists and therapy assistants that can give free and fully informed consent.
- Furthermore, the study will include both part-time and full-time staff with a minimum of six months of work experience with frail older people.
Who cannot join
- Phase one exclusion criteria
- The exclusion criteria, on the other hand, will include:
- people who cannot communicate in English;
- and individuals who are acutely medically unwell.
- Phase two exclusion criteria
- The second phase of the study will, on the other hand, exclude:
- all staff who do not have routine direct contact with patients' care, for example, the senior managers.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Dorset NHS Foundation Trust
Bournemouth, Christchurch, BH7 7DW
About this study
Official title: Exploring the Lived Experience of Control and Wellbeing of Older Persons Diagnosed With Frailty Within the Care Service Provision in Southern England
The proposed study seeks to explore the lived experience of control and wellbeing of older people diagnosed with frailty within the care service provision in southern England.
In the study, the researcher will talk with older people diagnosed with frailty and the professionals that provide care to them. The researcher is interested in understanding participants' experiences of a sense of control and how health and social care services affect this experience.
Read more
Although research has shown that rehabilitation can be effective in maintaining physical activity often frail older people do not wish to take up the rehabilitation services provided. Research in this area has been dominated by health care professionals' views about frailty and how services should be provided. Services could be improved by learning from the first-hand experiences of older people living with frailty and what they feel increases their level of control and wellbeing within their service use. The factors which increase their sense of control and wellbeing can then be built into future service development, inform care policies, and provide new understanding for future research to develop services which are more attractive and relevant for older frail people.
All persons aged 65 years and over, with a diagnosis of frailty will be eligible to take part in one to one interviews with the researcher. From the interviews principles underpinning good practice which enhances the sense of control and wellbeing in older people's lives and within the services received will be identified. These will be shared with professional care providers including nurses, doctors, and physiotherapists who routinely work with frail older people to gain insights into how these principles can be integrated into practice and developed in policy and future service development. The findings will, therefore, help to develop services which ensure that they are supportive and increase a sense of control in life rather than getting in the way of this.
The study is expected to last 12 months and up to 30 participants (20 older people and 10 Hospital staff) will be recruited to take part in the study.
- Conditions
- Frailty, Older People, Sense of Control
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Frail Older People | The first phase of the data collection process will include one to one interviews with up to twenty (20) frail older people. The pre-selected inclusion criteria for this category of participants include; older people (aged 65 years and over); individuals diagnosed with frailty and receiving (part of their) care services at the Day Hospital; the capacity to give free and fully informed consent; ability to use the English language, as well as judgement by the clinical staff and/or nominated manager that the potential participant can take part in an in-depth interview. | |
| Day Hospital Staff | The second phase of the data collection process will entail one to one interviews with up to ten (10) Staff at the Day Hospital. The study will include staff that routinely work with frail older people at the Day Hospital including nurses (registered and unregistered), doctors, physiotherapists, occupational therapists and therapy assistants that can give free and fully informed consent. Furthermore, the study will include both part-time and full-time staff with a minimum of six months of work experience with frail older people. |
What is being measured
The primary outcome is the main question the study is designed to answer.
How frail older people understand and experience control in their lives and care
The study will highlight frail older people's experiences, opinions and viewpoints on their sense of control in their lives and care processes and how this impacts on their dignity and well-being.
Measured: Up to one and a half hours
How frail older peoples' experiences can be used to shape and enhance care design and delivery.
The study will aslo highlight how health and social care practices can draw from older people's experiences to inform the design and delivery of care services.
Measured: Up to one and a half hours
How professional care providers can integrate into care practice principles that enhance service users' sense of control and well-being.
The study will help professional care providers working with older people to develop services which ensure that they are supportive and increase a sense of control in life rather than getting in the way of this.
Measured: Up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start15 Sep 2021
- Primary completion21 Feb 2022
- Study completion21 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Ellis-Hill, Study director, Chief Investigator/Senior Lecturer In Qualitative Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503811
- Sponsor's protocol ID
- AN282540
- Acronym
- CONtrol
- Status last verified
- Mar 2022
- First submitted
- 5 Aug 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The researcher will ensure that the Data is made open and accessible to other researchers in line with the provisions of the InnovateDignity Project Data Management Plan and the Bournemouth University Research Data Policy. Once the study has ended, anonymised data from the project will be deposited in the 'UK Data Archive' in Qualibank for example and QuDEX as a way of ensuring that the data are easily accessible to other researchers in the specific field of study and/or social scientists in related fields such as health care and policy research. However, there will be an embargo of up to 3 years on publications, after which data will be made available and accessible via the UK Data Archive. The data will be secured in line with the UK Data Archive policies and at the end of the project and the three-year embargo, researchers seeking access to the data will have to go through the UK Data Service access processes.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Lived Experience of Control and Wellbeing of Older Persons Diagnosed With Frailty Within the Care Service Provision in Southern England
- ClinicalTrials.gov ID
- NCT04503811
- Acronym / sponsor ID
- CONtrol / AN282540
- Conditions
- Frailty, Older People, Sense of Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 7 Aug 2020 (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.
The proposed study seeks to explore the lived experience of control and wellbeing of older people diagnosed with frailty within the care service provision in southern England.
In the study, the researcher will talk with older people diagnosed with frailty and the professionals that provide care to them. The researcher is interested in understanding participants' experiences of a sense of control and how health and social care services affect this experience.
Although research has shown that rehabilitation can be effective in maintaining physical activity often frail older people do not wish to take up the rehabilitation services provided. Research in this area has been dominated by health care professionals' views about frailty and how services should be provided. Services could be improved by learning from the first-hand experiences of older people living with frailty and what they feel increases their level of control and wellbeing within their service use. The factors which increase their sense of control and wellbeing can then be built into future service development, inform care policies, and provide new understanding for future research to develop services which are more attractive and relevant for older frail people.
All persons aged 65 years and over, with a diagnosis of frailty will be eligible to take part in one to one interviews with the researcher. From the interviews principles underpinning good practice which enhances the sense of control and wellbeing in older people's lives and within the services received will be identified. These will be shared with professional care providers including nurses, doctors, and physiotherapists who routinely work with frail older people to gain insights into how these principles can be integrated into practice and developed in policy and future service development. The findings will, therefore, help to develop services which ensure that they are supportive and increase a sense of control in life rather than getting in the way of this.
The study is expected to last 12 months and up to 30 participants (20 older people and 10 Hospital staff) will be recruited to take part in the study.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail Older People | – | –The first phase of the data collection process will include one to one interviews with up to twenty (20) frail older people. The pre-selected inclusion criteria for this category of participants include; older people (aged 65 years and over); individuals diagnosed with frailty and receiving (part of their) care services at the Day Hospital; the capacity to give free and fully informed consent; ability to use the English language, as well as judgement by the clinical staff and/or nominated manager that the potential participant can take part in an in-depth interview. |
| Day Hospital Staff | – | –The second phase of the data collection process will entail one to one interviews with up to ten (10) Staff at the Day Hospital. The study will include staff that routinely work with frail older people at the Day Hospital including nurses (registered and unregistered), doctors, physiotherapists, occupational therapists and therapy assistants that can give free and fully informed consent. Furthermore, the study will include both part-time and full-time staff with a minimum of six months of work experience with frail older people. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study will focus on frail older people and Day Hospital staff that provide care to them.
Key inclusion criteria (8 listed)
- Phase one inclusion criteria (frail older people) The pre-selected inclusion criteria for this category of participants include;
- older people (aged 65 years and over);
- individuals diagnosed with frailty and receiving (part of their) care services at the Day Hospital;
- the capacity to give free and fully informed consent;
- ability to use the English language, as well as judgement by the clinical staff and/or nominated manager that the potential participant can take part in an in-depth interview.
Key exclusion criteria (7 listed)
- Phase one exclusion criteria
- people who cannot communicate in English;
- and individuals who are acutely medically unwell.
- Phase two exclusion criteria
- all staff who do not have routine direct contact with patients' care, for example, the senior managers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
How frail older people understand and experience control in their lives and care
Time frame: Up to one and a half hours
The study will highlight frail older people's experiences, opinions and viewpoints on their sense of control in their lives and care processes and how this impacts on their dignity and well-being.
How frail older peoples' experiences can be used to shape and enhance care design and delivery.
Time frame: Up to one and a half hours
The study will aslo highlight how health and social care practices can draw from older people's experiences to inform the design and delivery of care services.
How professional care providers can integrate into care practice principles that enhance service users' sense of control and well-being.
Time frame: Up to one hour
The study will help professional care providers working with older people to develop services which ensure that they are supportive and increase a sense of control in life rather than getting in the way of this.
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 2 Mar 2022.
- Individual participant dataSharing planned: Yes. The researcher will ensure that the Data is made open and accessible to other researchers in line with the provisions of the InnovateDignity Project Data Management Plan and the Bournemouth University Research Data Policy. Once the study has ended, anonymised data from the project will be deposited in the 'UK Data Archive' in Qualibank for example and QuDEX as a way of ensuring that the data are easily accessible to other researchers in the specific field of study and/or social scientists in related fields such as health care and policy research. However, there will be an embargo of up to 3 years on publications, after which data will be made available and accessible via the UK Data Archive. The data will be secured in line with the UK Data Archive policies and at the end of the project and the three-year embargo, researchers seeking access to the data will have to go through the UK Data Service access processes.
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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.
Caroline Ellis-Hill study director
Chief Investigator/Senior Lecturer In Qualitative Research
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 Frailty and Older People, run by Bournemouth University 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 8 inclusion and 7 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 2 Mar 2022. 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?
How frail older people understand and experience control in their lives and care (time frame: Up to one and a half hours). 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 2 Mar 2022.