Quality of LifeNCT04828018
Care of the Ageing Veteran Population: Developing an Evidence Base for the Royal Hospital Chelsea Model of Care
An observational study of Quality of Life and Aging Well, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Royal Hospital Chelsea (RHC) has provided a sheltered housing environment alongside integrated health and social care and comradeship for British Army veterans since 1692, following a decree by King Charles II to aid the "relief of veterans broken by age and war" (RHC, 2018). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Aging Well
- What is being tested?
- Coffee Morning, Recruitment Leaflets and Consent Form completion
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 May 2021to 24 Jan 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population comprises key staff employees of Royal Hospital Chelsea (n=19), residents of Royal Hospital Chelsea (known as In-Pensioners) (n=25) and new In-Pensioners (n=40)who are admitted to the institution over a 12 month period (to complete n=2 Quality of Life Questionnaires only)
Who may be able to join
- Participants identified as Key Staff, In-Pensioner residents and new In-Pensioners at Royal Hospital Chelsea will be eligible to be included in the study.
Who cannot join
- Anyone who is not employed by Royal Hospital Chelsea and identified as a Key Member of staff, or is not an In-Pensioner resident at Royal Hospital Chelsea will be excluded from the study.
- Any potential participant who does not complete a consent form will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Royal Hospital Chelsea (RHC) has provided a sheltered housing environment alongside integrated health and social care and comradeship for British Army veterans since 1692, following a decree by King Charles II to aid the "relief of veterans broken by age and war" (RHC, 2018). Today approximately 300 In-Pensioners, known globally as 'Chelsea Pensioners' live at RHC. They also have access to an on-site infirmary providing nursing or personal care for up to 68 people (CQC, 2019).
RHC is in central London (UK) and comprises of several historical buildings, protected by the organisations Mission Statement to "…safeguard their historic home for the veterans of tomorrow". In-Pensioner's must have served in the British Army as a non-commissioned officer (or have served at least 12 years 'in the ranks' prior to becoming a commissioned officer), be aged 65 or over, be free of any financial obligations to dependents, and at the time of admission be able to live independently. Traditionally a male-only residence, RHC welcomed its first female Army veteran in 2009.
Read more
There is an absence of evidence to support the impact of care delivery and the Chelsea Pensioner experience, with the only evidence being RHC Annual and Care Quality Commission (CQC) reports which focus on strategic and operational matters rather than the impact of the wider social care or environment.
This lack of evidence presents a unique opportunity to evaluate RHC's current service provision, inform future direction and address the hiatus in evidence-based research to quantify the impact of its model of care.
Read the detailed description
The research will seek to address two main aims:
- To gain an understanding of the current Royal Hospital Chelsea (RHC) model of care by:
- Evidencing the influence the model of care has on In-Pensioner health outcomes
- Understanding the influence the model of care has on wider social care provision
- Reflecting on the contribution the environment has on the In-Pensioner experience, their health outcomes, and quality of life
- To inform future RHC care provision by:
- Mapping current services, future need and sustainability of the model
- Projecting findings to inform the growth of existing services for future generations of ageing veterans
The findings will inform RHC strategic direction as it continues to deliver care provision to current and future generations of veteran, identify the value of RHC interventions, and explore any development of service provision in the form of potential outreach care. Further, the findings will look to inform wider social care provision which may contribute to national health and social care policy.
The findings of the study may be applicable to the wider care provision within similar residential care establishments as they will seek to present service delivery findings from both a staff (care provider) and resident (care recipient) perspective and evidence best practice.
The findings may contribute to national health and social care policy (UK).
Key staff and Royal Hospital Chelsea 'In-Pensioner' residents will be interviewed for this study. New In-Pensioner residents will be invited to complete two Quality of Life Questionnaires (one on arrival and one six months later).
- Conditions
- Quality of Life, Aging Well
- Being tested
- Coffee Morning, Recruitment Leaflets, Consent Form completion, Participant Information Sheet, New In-Pensioner Resident Information Pack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coffee MorningOther
Coffee mornings (a maximum of n=2) will be held to raise awareness of the project and to promote participant recruitment. These will be held remotely via video conference if Covid-19 restrictions prevent in-person attendance by the researcher.
Recruitment LeafletsOther
Recruitment leaflets will be hand-delivered to all In-Pensioner residents at Royal Hospital Chelsea. Leaflets will be delivered internally by Royal Hospital Chelsea internal mail-room
Consent Form completionOther
All participants will be asked to complete Consent Forms before engaging in the study. The researcher will be available to answer any questions via phone calls if required.
Participant Information SheetOther
All participants will receive Information Sheets which they will read in their own rooms (or elsewhere for Key Staff). The researcher will be available to answer any questions via phone calls if required.
New In-Pensioner Resident Information PackOther
New In-Pensioner resident information packs will be distributed by a member of RHC staff as part of their 'arrivals' process and six months after residency at RHC. The researcher will be available to answer any questions via phone calls if required.
Key Staff InterviewsOther
Key Staff interviews will take place with the Researcher in a private space at Royal Hospital Chelsea. If Covid-19 restrictions are in place, 'online' interviews will take place using a digital platform such as 'Skype', 'Teams' or 'Zoom'.
In-Pensioner Resident InterviewsOther
In-Pensioner resident interviews will take place with the Researcher in a private space at Royal Hospital Chelsea. If Covid-19 restrictions are in place, 'online' interviews will take place using a digital platform such as 'Skype', 'Teams' or 'Zoom'.
ICECAP-A Quality of Life QuestionnaireOther
New In-Pensioner residents and In-Pensioner residents taking part in the Qualitative Interviews will be asked to complete n=2 QoL questionnaires. New In-Pensioners will be asked to complete their QoL measures when the individual takes up residence at Royal Hospital Chelsea, the second six months later. In-Pensioner residents taking part in the interviews will be asked to complete the questionnaire at the start of the interview.
WHOQOL-BREF Quality of Life QuestionnaireOther
New In-Pensioner residents and In-Pensioner residents taking part in the Qualitative Interviews will be asked to complete n=2 QoL questionnaires. New In-Pensioners will be asked to complete their QoL measures when the individual takes up residence at Royal Hospital Chelsea, the second six months later. In-Pensioner residents taking part in the interviews will be asked to complete the questionnaire at the start of the interview.
| Study group | Role | What they receive |
|---|---|---|
| Key Staff | Key Staff will take part in one interview lasting up to 60 minutes Receives: Other: Coffee Morning; Other: Recruitment Leaflets; Other: Consent Form completion; Other: Participant Information Sheet; Other: Key Staff Interviews | |
| In-Pensioners | Royal Hospital Chelsea In-Pensioners will take part in one interview lasting up to 90 minutes and complete n=2 Quality of Life Questionnaires (ICECAP-A and WHOQOL-BREF) at the start of their qualitative interview. Receives: Other: Coffee Morning; Other: Recruitment Leaflets; Other: Consent Form completion; Other: Participant Information Sheet; Other: In-Pensioner Resident Interviews; Other: ICECAP-A Quality of Life Questionnaire; Other: WHOQOL-BREF Quality of Life Questionnaire | |
| New In-Pensioner | New In-Pensioners wil be asked to complete a total of n=4 Quality of Life Questionnaires (ICECAP-A and WHOQOL-BREF), n=2 on admission to Royal Hospital Chelsea and n=2 six months after admission. Receives: Other: New In-Pensioner Resident Information Pack; Other: ICECAP-A Quality of Life Questionnaire; Other: WHOQOL-BREF Quality of Life Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Key Staff Interviews
Semi-structured 'in-person' interviews will take place with n=25 key staff at Royal Hospital Chelsea. Analysis of this data will be assessed using NVIVO software.
Measured: Interviews, lasting 60 minutes per interview, will take place over a 3-month period. Data analysis will take place over a 10-month period during years two and three of the study.
In-Pensioner Interviews
Semi-structured 'in-person' interviews will take place with n=25 Royal Hospital Chelsea In-Pensioner residents. Analysis of this data will be assessed using NVIVO software.
Measured: Interviews, lasting up to 90 minutes per interview, will take place over an 8-month period. Data analysis will take place over a 10-month period during years two and three of the study.
Royal Hospital Chelsea Documentation Review
Royal Hospital Chelsea documents including organisational policies, annual reports, healthcare governance reports and data from the Margaret Thatcher Infirmary will be reviewed. Data collected will be analysed using SPSS software.
Measured: Documentation review and data analysis will take place ahead of the writing-up phase of the study, approximately 15 months.
ICECAP-A Quality of Life Questionnaire
The ICECAP-A Quality of Life questionnaire will be completed by new In-Pensioner residents, and In-Pensioners selected for Qualitative Interview at Royal Hospital Chelsea. Data analysis will take place using SPSS software.
ICECAP-A is the ICEpop CAPability measure for Adults Quality of Life measure and is scored using the Likert Scale framework. The questionnaire has a minimum value of 1 and a maximum value of 4, with the maximum value indicating a better outcome.
Measured: Questionnaires will be completed over a 12-month period during years two and three of the study. Data analysis will take place over a 10-month period during years two and three of the study.
WHOQOL-BREF Quality of Life Questionnaire
The WHOQOL-BREF Quality of Life questionnaire will be completed by new In-Pensioner residents, and In-Pensioners selected for Qualitative Interview at Royal Hospital Chelsea. Data analysis will take place using SPSS software.
The WHOQOL-BREF is the World Health Organisation Quality of Life - Brief questionnaire which is a short-form version of the WHOQOL-100 Quality of Life measure and is scored using the Likert Scale framework. The questionnaire has a minimum value of 1 and a maximum value of 5, with the maximum value indicating a better outcome.
Measured: Questionnaires will be completed over a 12-month period during years two and three of the study. Data analysis will take place over a 10-month period during years two and three of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start11 May 2021
- Primary completion7 Nov 2022
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Hospital Chelsea
- Responsible party
- Sponsor
- Investigators
- Gemma Wilson-Menzfeld, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828018
- Sponsor's protocol ID
- 119967
- Status last verified
- Apr 2024
- First submitted
- 2 Mar 2021
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently in discussion
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care of the Ageing Veteran Population: Developing an Evidence Base for the Royal Hospital Chelsea Model of Care
- ClinicalTrials.gov ID
- NCT04828018
- Acronym / sponsor ID
- 119967
- Conditions
- Quality of Life, Aging Well
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Royal Hospital Chelsea
- Study start
- 11 May 2021 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 1 Apr 2021 (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.
Royal Hospital Chelsea (RHC) has provided a sheltered housing environment alongside integrated health and social care and comradeship for British Army veterans since 1692, following a decree by King Charles II to aid the "relief of veterans broken by age and war" (RHC, 2018). Today approximately 300 In-Pensioners, known globally as 'Chelsea Pensioners' live at RHC. They also have access to an on-site infirmary providing nursing or personal care for up to 68 people (CQC, 2019).
RHC is in central London (UK) and comprises of several historical buildings, protected by the organisations Mission Statement to "…safeguard their historic home for the veterans of tomorrow". In-Pensioner's must have served in the British Army as a non-commissioned officer (or have served at least 12 years 'in the ranks' prior to becoming a commissioned officer), be aged 65 or over, be free of any financial obligations to dependents, and at the time of admission be able to live independently. Traditionally a male-only residence, RHC welcomed its first female Army veteran in 2009.
There is an absence of evidence to support the impact of care delivery and the Chelsea Pensioner experience, with the only evidence being RHC Annual and Care Quality Commission (CQC) reports which focus on strategic and operational matters rather than the impact of the wider social care or environment.
This lack of evidence presents a unique opportunity to evaluate RHC's current service provision, inform future direction and address the hiatus in evidence-based research to quantify the impact of its model of care.
Detailed description
The research will seek to address two main aims:
- To gain an understanding of the current Royal Hospital Chelsea (RHC) model of care by:
- Evidencing the influence the model of care has on In-Pensioner health outcomes
- Understanding the influence the model of care has on wider social care provision
- Reflecting on the contribution the environment has on the In-Pensioner experience, their health outcomes, and quality of life
- To inform future RHC care provision by:
- Mapping current services, future need and sustainability of the model
- Projecting findings to inform the growth of existing services for future generations of ageing veterans
The findings will inform RHC strategic direction as it continues to deliver care provision to current and future generations of veteran, identify the value of RHC interventions, and explore any development of service provision in the form of potential outreach care. Further, the findings will look to inform wider social care provision which may contribute to national health and social care policy.
The findings of the study may be applicable to the wider care provision within similar residential care establishments as they will seek to present service delivery findings from both a staff (care provider) and resident (care recipient) perspective and evidence best practice.
The findings may contribute to national health and social care policy (UK).
Key staff and Royal Hospital Chelsea 'In-Pensioner' residents will be interviewed for this study. New In-Pensioner residents will be invited to complete two Quality of Life Questionnaires (one on arrival and one six months later).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Key Staff | – | Other: Coffee Morning, Other: Recruitment Leaflets, Other: Consent Form completion, Other: Participant Information Sheet, Other: Key Staff InterviewsKey Staff will take part in one interview lasting up to 60 minutes |
| In-Pensioners | – | Other: Coffee Morning, Other: Recruitment Leaflets, Other: Consent Form completion, Other: Participant Information Sheet, Other: In-Pensioner Resident Interviews, Other: ICECAP-A Quality of Life Questionnaire, Other: WHOQOL-BREF Quality of Life QuestionnaireRoyal Hospital Chelsea In-Pensioners will take part in one interview lasting up to 90 minutes and complete n=2 Quality of Life Questionnaires (ICECAP-A and WHOQOL-BREF) at the start of their qualitative interview. |
| New In-Pensioner | – | Other: New In-Pensioner Resident Information Pack, Other: ICECAP-A Quality of Life Questionnaire, Other: WHOQOL-BREF Quality of Life QuestionnaireNew In-Pensioners wil be asked to complete a total of n=4 Quality of Life Questionnaires (ICECAP-A and WHOQOL-BREF), n=2 on admission to Royal Hospital Chelsea and n=2 six months after admission. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population comprises key staff employees of Royal Hospital Chelsea (n=19), residents of Royal Hospital Chelsea (known as In-Pensioners) (n=25) and new In-Pensioners (n=40)who are admitted to the institution over a 12 month period (to complete n=2 Quality of Life Questionnaires only)
Key inclusion criteria (1 listed)
- Participants identified as Key Staff, In-Pensioner residents and new In-Pensioners at Royal Hospital Chelsea will be eligible to be included in the study.
Key exclusion criteria (2 listed)
- Anyone who is not employed by Royal Hospital Chelsea and identified as a Key Member of staff, or is not an In-Pensioner resident at Royal Hospital Chelsea will be excluded from the study.
- Any potential participant who does not complete a consent form will be excluded from the study.
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 |
|---|---|---|
| Coffee MorningCoffee mornings (a maximum of n=2) will be held to raise awareness of the project and to promote participant recruitment. These will be held remotely via video conference if Covid-19 restrictions prevent in-person attendance by the researcher. | Other | In-Pensioners, Key Staff |
| Recruitment LeafletsRecruitment leaflets will be hand-delivered to all In-Pensioner residents at Royal Hospital Chelsea. Leaflets will be delivered internally by Royal Hospital Chelsea internal mail-room | Other | In-Pensioners, Key Staff |
| Consent Form completionAll participants will be asked to complete Consent Forms before engaging in the study. The researcher will be available to answer any questions via phone calls if required. | Other | In-Pensioners, Key Staff |
| Participant Information SheetAll participants will receive Information Sheets which they will read in their own rooms (or elsewhere for Key Staff). The researcher will be available to answer any questions via phone calls if required. | Other | In-Pensioners, Key Staff |
| New In-Pensioner Resident Information PackNew In-Pensioner resident information packs will be distributed by a member of RHC staff as part of their 'arrivals' process and six months after residency at RHC. The researcher will be available to answer any questions via phone calls if required. | Other | New In-Pensioner |
| Key Staff InterviewsKey Staff interviews will take place with the Researcher in a private space at Royal Hospital Chelsea. If Covid-19 restrictions are in place, 'online' interviews will take place using a digital platform such as 'Skype', 'Teams' or 'Zoom'. | Other | Key Staff |
| In-Pensioner Resident InterviewsIn-Pensioner resident interviews will take place with the Researcher in a private space at Royal Hospital Chelsea. If Covid-19 restrictions are in place, 'online' interviews will take place using a digital platform such as 'Skype', 'Teams' or 'Zoom'. | Other | In-Pensioners |
| ICECAP-A Quality of Life QuestionnaireNew In-Pensioner residents and In-Pensioner residents taking part in the Qualitative Interviews will be asked to complete n=2 QoL questionnaires. New In-Pensioners will be asked to complete their QoL measures when the individual takes up residence at Royal Hospital Chelsea, the second six months later. In-Pensioner residents taking part in the interviews will be asked to complete the questionnaire at the start of the interview. | Other | In-Pensioners, New In-Pensioner |
| WHOQOL-BREF Quality of Life QuestionnaireNew In-Pensioner residents and In-Pensioner residents taking part in the Qualitative Interviews will be asked to complete n=2 QoL questionnaires. New In-Pensioners will be asked to complete their QoL measures when the individual takes up residence at Royal Hospital Chelsea, the second six months later. In-Pensioner residents taking part in the interviews will be asked to complete the questionnaire at the start of the interview. | Other | In-Pensioners, New In-Pensioner |
Primary outcome
Key Staff Interviews
Time frame: Interviews, lasting 60 minutes per interview, will take place over a 3-month period. Data analysis will take place over a 10-month period during years two and three of the study.
Semi-structured 'in-person' interviews will take place with n=25 key staff at Royal Hospital Chelsea. Analysis of this data will be assessed using NVIVO software.
In-Pensioner Interviews
Time frame: Interviews, lasting up to 90 minutes per interview, will take place over an 8-month period. Data analysis will take place over a 10-month period during years two and three of the study.
Semi-structured 'in-person' interviews will take place with n=25 Royal Hospital Chelsea In-Pensioner residents. Analysis of this data will be assessed using NVIVO software.
Royal Hospital Chelsea Documentation Review
Time frame: Documentation review and data analysis will take place ahead of the writing-up phase of the study, approximately 15 months.
Royal Hospital Chelsea documents including organisational policies, annual reports, healthcare governance reports and data from the Margaret Thatcher Infirmary will be reviewed. Data collected will be analysed using SPSS software.
ICECAP-A Quality of Life Questionnaire
Time frame: Questionnaires will be completed over a 12-month period during years two and three of the study. Data analysis will take place over a 10-month period during years two and three of the study.
The ICECAP-A Quality of Life questionnaire will be completed by new In-Pensioner residents, and In-Pensioners selected for Qualitative Interview at Royal Hospital Chelsea. Data analysis will take place using SPSS software. ICECAP-A is the ICEpop CAPability measure for Adults Quality of Life measure and is scored using the Likert Scale framework. The questionnaire has a minimum value of 1 and a maximum value of 4, with the maximum value indicating a better outcome.
WHOQOL-BREF Quality of Life Questionnaire
Time frame: Questionnaires will be completed over a 12-month period during years two and three of the study. Data analysis will take place over a 10-month period during years two and three of the study.
The WHOQOL-BREF Quality of Life questionnaire will be completed by new In-Pensioner residents, and In-Pensioners selected for Qualitative Interview at Royal Hospital Chelsea. Data analysis will take place using SPSS software. The WHOQOL-BREF is the World Health Organisation Quality of Life - Brief questionnaire which is a short-form version of the WHOQOL-100 Quality of Life measure and is scored using the Likert Scale framework. The questionnaire has a minimum value of 1 and a maximum value of 5, with the maximum value indicating a better outcome.
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 3 Apr 2024.
- Individual participant dataSharing planned: Undecided. Currently in discussion
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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.
Gemma Wilson-Menzfeld, PhD principal investigator
Northumbria University
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 Quality of Life and Aging Well, run by Northumbria 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 1 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 3 Apr 2024. 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?
Key Staff Interviews (time frame: Interviews, lasting 60 minutes per interview, will take place over a 3-month period. Data analysis will take place over a 10-month period during years two and three of the study.). The study lists 5 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 3 Apr 2024.