FrailtyNCT03394534
Comprehensive Geriatric Assessment in Primary Care: A Randomised Feasibility Trial
A study testing CGA group in people with Frailty, run by University of Derby at 1 site in United Kingdom.
Trial summary
The study aims to explore feasibility of implementing a tailored CGA to older adults with frailty and evaluate staff and patients perception of the intervention. In line with this, the objectives of the study are: 1. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Frailty
- What is being tested?
- CGA group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2019to 30 Sep 2021
- Phase
- Interventional
- 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 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 to 95 years
- eFI score > 0.12
Who cannot join
- Do not meet criteria for frailty based on Gait speed, timed up and go test and PRISMA questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 'Comprehensive Geriatric Assessment' for Older Adults With Frailty Within Primary Care Setting: A Randomised Feasibility Trial
The study aims to explore feasibility of implementing a tailored CGA to older adults with frailty and evaluate staff and patients perception of the intervention. In line with this, the objectives of the study are:
- To assess applicability of finding older adults with frailty using eFI and delivering subsequent CGA and care planning at patients' home
- To investigate staff and older adults' perception of CGA programme
- To assess the health care resource usage and cost of the CGA programme
- To measure key health related outcome domains including function, quality of life, loneliness, pain, falls and mobility.
- Conditions
- Frailty
- Being tested
- CGA group
- Keywords
- Comprehensive Geriatric Assessment, Frailty, electronic Frailty Index, eFI, Care and Support plan, Primary Care
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGA groupOther
CGA Plus Individualised Care and Support Plan delivered by Advanced Clinical Practitioner (ACP)
| Study group | Role | What they receive |
|---|---|---|
| CGA group | Experimental | Not described Receives: Other: CGA group |
| Treatment as Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalisation and Nursing Home Admissions
Number of hospital and/or care home admissions during the 6 months period and reported in terms of admitted v. not admitted
Measured: at 6 months post intervention
Secondary outcomes (8)
Functional Status
Improve Patient functional ability measured using Functional Independence Measure (FIM) questionnaire total score
Measured: at baseline and 6 months post intervention
Loneliness
Improve overall, emotional, and social loneliness calculated using the De Jong Gierveld Loneliness Scale total score. The scale is used to assess subjective perception of social participation or isolation in elderly adults.
Measured: at baseline and 6 months post intervention
Health related Quality of Life
Change in health related quality of life calculated using the 36-Item Short Form Survey (SF-36). The Sf-36 is patient reported outcome measure with a set of generic quality of life measures including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health subscales.
Measured: at baseline and 6 months post intervention
Number of 999 calls and A+E attendance during the 6 months period
Measured: at 6 months post intervention
Length of time spent on A+E during the 6 months period
Measured: at 6 months post intervention
Length of time stayed in hospital or care home during the 6 months period
Measured: at 6 months post intervention
Therapist and staff time spent on CGA during the 6 months period
Measured: at 6 months post intervention
Number of GP/GP out of office attendance (including calls to GP) during the 6 months period
Measured: at 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start15 Jan 2019
- Primary completion15 Jun 2019
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Derby
- Sponsor type
- University, hospital or other
- Collaborators
- Derbyshire Clinical Commissioning Groups
- Responsible party
- Principal investigator, Reza Safari, University of Derby
- Investigators
- Reza Safari, PhD, Principal investigator, University of Derby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394534
- Sponsor's protocol ID
- v3.6
- Status last verified
- May 2022
- First submitted
- 18 Dec 2017
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edmans J, Bradshaw L, Gladman JR, Franklin M, Berdunov V, Elliott R, Conroy SP. The Identification of Seniors at Risk (ISAR) score to predict clinical outcomes and health service costs in older people discharged from UK acute medical units. Age Ageing. 2013 Nov;42(6):747-53. doi: 10.1093/ageing/aft054. Epub 2013 May 10.
PubMed 23666405Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
PubMed 23395245Gladman JR, Conroy SP, Ranhoff AH, Gordon AL. New horizons in the implementation and research of comprehensive geriatric assessment: knowing, doing and the 'know-do' gap. Age Ageing. 2016 Mar;45(2):194-200. doi: 10.1093/ageing/afw012.
PubMed 26941353Fit for Frailty - Developing, commissioning and managing services for people living with frailty in community settings - a report from the British Geriatrics Society and the Royal College of General Practitioners 2015.
Clegg A, Rogers L, Young J. Diagnostic test accuracy of simple instruments for identifying frailty in community-dwelling older people: a systematic review. Age Ageing. 2015 Jan;44(1):148-52. doi: 10.1093/ageing/afu157. Epub 2014 Oct 29.
PubMed 25355618Safari R, Jackson J, Boole L. Comprehensive geriatric assessment delivered by advanced nursing practitioners within primary care setting: a mixed-methods pilot feasibility randomised controlled trial. BMC Geriatr. 2023 Aug 24;23(1):513. doi: 10.1186/s12877-023-04218-0.
PubMed 37620760
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Comprehensive Geriatric Assessment' for Older Adults With Frailty Within Primary Care Setting: A Randomised Feasibility Trial
- ClinicalTrials.gov ID
- NCT03394534
- Acronym / sponsor ID
- v3.6
- Conditions
- Frailty
- Keywords
- Comprehensive Geriatric Assessment, Frailty, electronic Frailty Index, eFI, Care and Support plan, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of DerbyUniversity, hospital or other
- Collaborators
- Derbyshire Clinical Commissioning Groups
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 9 Jan 2018 (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 study aims to explore feasibility of implementing a tailored CGA to older adults with frailty and evaluate staff and patients perception of the intervention. In line with this, the objectives of the study are:
- To assess applicability of finding older adults with frailty using eFI and delivering subsequent CGA and care planning at patients' home
- To investigate staff and older adults' perception of CGA programme
- To assess the health care resource usage and cost of the CGA programme
- To measure key health related outcome domains including function, quality of life, loneliness, pain, falls and mobility.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGA group | Experimental | Other: CGA group |
| Treatment as Usual | No intervention | – |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 to 95 years
- eFI score > 0.12
Key exclusion criteria (1 listed)
- Do not meet criteria for frailty based on Gait speed, timed up and go test and PRISMA questionnaire
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 |
|---|---|---|
| CGA groupCGA Plus Individualised Care and Support Plan delivered by Advanced Clinical Practitioner (ACP) | Other | CGA group |
Primary outcome
Hospitalisation and Nursing Home Admissions
Time frame: at 6 months post intervention
Number of hospital and/or care home admissions during the 6 months period and reported in terms of admitted v. not admitted
8 secondary outcomes
Functional Status
Time frame: at baseline and 6 months post intervention
Loneliness
Time frame: at baseline and 6 months post intervention
Health related Quality of Life
Time frame: at baseline and 6 months post intervention
Number of 999 calls and A+E attendance during the 6 months period
Time frame: at 6 months post intervention
Length of time spent on A+E during the 6 months period
Time frame: at 6 months post intervention
Length of time stayed in hospital or care home during the 6 months period
Time frame: at 6 months post intervention
Therapist and staff time spent on CGA during the 6 months period
Time frame: at 6 months post intervention
Number of GP/GP out of office attendance (including calls to GP) during the 6 months period
Time frame: at 6 months post intervention
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 18 May 2022.
- Background: PubMed 23666405Edmans J, Bradshaw L, Gladman JR, Franklin M, Berdunov V, Elliott R, Conroy SP. The Identification of Seniors at Risk (ISAR) score to predict clinical outcomes and health service costs in older people discharged from UK acute medical units. Age Ageing. 2013 Nov;42(6):747-53. doi: 10.1093/ageing/aft054. Epub 2013 May 10.
- Background: PubMed 23395245Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Background: PubMed 26941353Gladman JR, Conroy SP, Ranhoff AH, Gordon AL. New horizons in the implementation and research of comprehensive geriatric assessment: knowing, doing and the 'know-do' gap. Age Ageing. 2016 Mar;45(2):194-200. doi: 10.1093/ageing/afw012.
- BackgroundFit for Frailty - Developing, commissioning and managing services for people living with frailty in community settings - a report from the British Geriatrics Society and the Royal College of General Practitioners 2015.
- Background: PubMed 25355618Clegg A, Rogers L, Young J. Diagnostic test accuracy of simple instruments for identifying frailty in community-dwelling older people: a systematic review. Age Ageing. 2015 Jan;44(1):148-52. doi: 10.1093/ageing/afu157. Epub 2014 Oct 29.
- Derived from this study: PubMed 37620760Safari R, Jackson J, Boole L. Comprehensive geriatric assessment delivered by advanced nursing practitioners within primary care setting: a mixed-methods pilot feasibility randomised controlled trial. BMC Geriatr. 2023 Aug 24;23(1):513. doi: 10.1186/s12877-023-04218-0.
- Individual participant dataSharing planned: No
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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.
Reza Safari, PhD principal investigator
University of Derby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGA group in people with Frailty, run by University of Derby 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 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 18 May 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?
Hospitalisation and Nursing Home Admissions (time frame: at 6 months post intervention). 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 NCT03394534, which also lists 6 linked publications.
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 18 May 2022.