AgeingNCT02617719
Comprehensive Geriatric Assessment in Primary Care: The Fit for Late Life Project
An observational study of Ageing, run by University of Southampton.
Trial summary
Comprehensive Geriatric Assessment is an effective process to identify and address the needs of older patients. In the United Kingdom this usually takes place in acute care or in the patients home. This project will assess the feasibility of implementing this service in primary care. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ageing
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Staff: Primary care staff who are involved in the care of patients aged 75 years and older from a single United Kingdom primary care practice. Patients: Patients aged 75 years and older from a single United Kingdom primary care practice. Carers: Carers of patients aged 75 years and older from a single United Kingdom primary care practice.
Who may be able to join
- Involved in care of patient aged 75 years or older at the participating United Kingdom primary care practice.
- Patient aged 75 years or older at the participating United Kingdom primary care practice.
- Carer of patient aged 75 years or older at the participating United Kingdom primary care practice.
Who cannot join
- Patient in end of life care
- Patient does not have the mental capacity to act. -
About this study
Official title: Comprehensive Geriatric Assessment in Primary Care: The Fit for Late Life
Comprehensive Geriatric Assessment is an effective process to identify and address the needs of older patients. In the United Kingdom this usually takes place in acute care or in the patients home. This project will assess the feasibility of implementing this service in primary care.
Read the detailed description
With the ageing of the United Kingdom population, it is crucial that evidence on optimal healthcare is effectively translated into improved clinical practice to both maximise the health and independence of older people as well as contain costs. Comprehensive Geriatric Assessment (CGA) is a multidimensional, interdisciplinary process used to identify and address the complex healthcare needs of older people. Evidence of its effectiveness has been confirmed in a number of systematic reviews and meta-analyses and beneficial outcomes reported include improved function and independence. However its implementation across healthcare settings remains variable. This study aims to establish the feasibility, acceptability and cost of implementing a Comprehensive Geriatric Assessment Clinic in a single primary care practice.
The Fit for Later Life Project describes the implementation of a Comprehensive Geriatric Assessment Clinic in primary care for older people who referred by their General Practitioner (GP). We will utilise a mixed-methods design including Normalisation Process Theory (NPT), a sociological toolkit designed to explore how different stakeholders engage with the real-world process of translating evidence into practice. Interviews and focus groups will be used to collect data from patients, carers and health professionals on coherence, cognitive participation, collective action, and reflexive monitoring. These data will be thematically analysed to identify barriers, strengths and weaknesses for the implementation of a Comprehensive Geriatric Assessment Clinic in primary care. A clinical audit of the records of older people who are service users at the participating practice will be conducted and an assessment will be made of the costs of the clinic. Together these data will provide implementation guidelines describing the feasibility and acceptability of a United Kingdom primary care Comprehensive Geriatric Assessment clinic.
The planned outcome is guidelines for the implementation of a Comprehensive Geriatric Assessment Clinic in United Kingdom primary care. The barriers and facilitators that affect starting and running the service will be described as will the patients who could potentially attend and those who actually attend. The costs will also be determined.
This research is funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care (NIHR CLAHRC) Wessex.
- Conditions
- Ageing
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 |
|---|---|---|
| Primary care | Staff, patients aged 75 years and older and their carers associated with a single, participating United Kingdom primary care practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of the acceptability of a Comprehensive Geriatric Assessment clinic in United Kingdom primary care
Qualitative interviews performed before and after the new clinic where the participants describe their perceptions and experience of the the new Comprehensive Geriatric Assessment in United Kingdom primary care.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgeingStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Lynn N Lansbury, PhD, Principal investigator, University of Southampton, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617719
- Sponsor's protocol ID
- b2xrypzt
- Status last verified
- Mar 2016
- First submitted
- 18 Nov 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Geriatric Assessment in Primary Care: The Fit for Late Life
- ClinicalTrials.gov ID
- NCT02617719
- Acronym / sponsor ID
- b2xrypzt
- Conditions
- Ageing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Nov 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Dec 2015 (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.
Comprehensive Geriatric Assessment is an effective process to identify and address the needs of older patients. In the United Kingdom this usually takes place in acute care or in the patients home. This project will assess the feasibility of implementing this service in primary care.
Detailed description
With the ageing of the United Kingdom population, it is crucial that evidence on optimal healthcare is effectively translated into improved clinical practice to both maximise the health and independence of older people as well as contain costs. Comprehensive Geriatric Assessment (CGA) is a multidimensional, interdisciplinary process used to identify and address the complex healthcare needs of older people. Evidence of its effectiveness has been confirmed in a number of systematic reviews and meta-analyses and beneficial outcomes reported include improved function and independence. However its implementation across healthcare settings remains variable. This study aims to establish the feasibility, acceptability and cost of implementing a Comprehensive Geriatric Assessment Clinic in a single primary care practice.
The Fit for Later Life Project describes the implementation of a Comprehensive Geriatric Assessment Clinic in primary care for older people who referred by their General Practitioner (GP). We will utilise a mixed-methods design including Normalisation Process Theory (NPT), a sociological toolkit designed to explore how different stakeholders engage with the real-world process of translating evidence into practice. Interviews and focus groups will be used to collect data from patients, carers and health professionals on coherence, cognitive participation, collective action, and reflexive monitoring. These data will be thematically analysed to identify barriers, strengths and weaknesses for the implementation of a Comprehensive Geriatric Assessment Clinic in primary care. A clinical audit of the records of older people who are service users at the participating practice will be conducted and an assessment will be made of the costs of the clinic. Together these data will provide implementation guidelines describing the feasibility and acceptability of a United Kingdom primary care Comprehensive Geriatric Assessment clinic.
The planned outcome is guidelines for the implementation of a Comprehensive Geriatric Assessment Clinic in United Kingdom primary care. The barriers and facilitators that affect starting and running the service will be described as will the patients who could potentially attend and those who actually attend. The costs will also be determined.
This research is funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care (NIHR CLAHRC) Wessex.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary care | – | –Staff, patients aged 75 years and older and their carers associated with a single, participating United Kingdom primary care practice. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Staff: Primary care staff who are involved in the care of patients aged 75 years and older from a single United Kingdom primary care practice. Patients: Patients aged 75 years and older from a single United Kingdom primary care practice. Carers: Carers of patients aged 75 years and older from a single United Kingdom primary care practice.
Key inclusion criteria (3 listed)
- Involved in care of patient aged 75 years or older at the participating United Kingdom primary care practice.
- Patient aged 75 years or older at the participating United Kingdom primary care practice.
- Carer of patient aged 75 years or older at the participating United Kingdom primary care practice.
Key exclusion criteria (2 listed)
- Patient in end of life care
- Patient does not have the mental capacity to act. -
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
Experience of the acceptability of a Comprehensive Geriatric Assessment clinic in United Kingdom primary care
Time frame: 6 months
Qualitative interviews performed before and after the new clinic where the participants describe their perceptions and experience of the the new Comprehensive Geriatric Assessment in United Kingdom primary care.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Ageing
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
Lynn N Lansbury, PhD principal investigator
University of Southampton, UK
Questions about this trial
What is this clinical trial studying?
An observational study of Ageing, run by University of Southampton.
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 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: status not confirmed, as of the sponsor's last update on 2 Mar 2016. 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.
Are results available for this study?
Results are not available in the source record.
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?
Experience of the acceptability of a Comprehensive Geriatric Assessment clinic in United Kingdom primary care (time frame: 6 months). 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 2016.