FrailtyNCT05849870
Comparing Frailty Care Pathways in Rural Primary Care: a Feasibility Study
A study testing Frailty care pathway for older people in a rural primary care setting in people with Frailty, run by Aberystwyth University at 1 site in United Kingdom.
Trial summary
Primary Care General Practitioners (GPs) are always looking at ways to improve the care of older people and ways to prevent older people from losing their independence. Pro-active provision of support often involves lifestyle advice and is a potentially important aspect of that, as it supports older people before… Read more about this study
- Who is it for?
- Ages 60 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- Frailty care pathway for older people in a rural primary care setting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2021to 30 May 2022
- 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 60 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults aged 60 years or older
- mild frailty or frailty based on the eFI,
- without severe cognitive impairment diagnoses,
- not currently taking part in other research or in the previous 6 months,
- willing to provide informed consent
Who cannot join
- are terminally ill
- have severe cognitive or psychological impairments,
- have experienced a severe, disabling stroke within the previous 6 months
- are unable to communicate in English.
- are currently taking part in other research project, or was part of research in the previous 6 months.
- have experienced a heart attack, or unstable angina within the previous 3 months.
- already receive advice that includes exercise and diet by health professionals and were referred at discharge for condition-specific rehabilitation (e.g. pulmonary rehabilitation, stroke rehabilitation) within the previous 6 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aberystwyth University
Aberystwyth, Ceredigion, SY23 3FD
About this study
Primary Care General Practitioners (GPs) are always looking at ways to improve the care of older people and ways to prevent older people from losing their independence. Pro-active provision of support often involves lifestyle advice and is a potentially important aspect of that, as it supports older people before acute care is needed. It's preventative caring, rather than reactive caring. But, implementing pro-active care is hampered by the high current workload of acute care, the uncertainty of 'what works' and whether patients are responsive to pro-active care plans. This project will explore different ways of providing pro-active support to older people who could be at risk of losing their independence and requiring frequent acute care. The benefits of pro-active care are arguably the greatest in these individuals.
Read the detailed description
This is randomised control trial design with a cluster randomisation, whereby each cluster (a GP surgery) will have a different intervention. As it's a feasibility study, there will only be one cluster per intervention.
Participants will be recruited from 4 local primary care surgeries, and if participants take part, they will have 4 visits, and will be randomly allocation of an intervention arm, or a control arm receiving usual care.
At the start, the participant would have 2 visits of a maximum of 2 hours to the participant's local GP surgery to undergo a variety of tasks and assessments about the participant's well-being, health and physical functioning. That could lead to an 'action plan' that is implemented. The participant will have the 3rd visit after 3 months, and a final (fourth) visit after 12 months. During the 3rd and 4th visit the participant will repeat various tasks and assessments done in visit 1 and 2.
The project comprises different activities in the different GP surgeries. The project compares different approaches that each surgery takes. Generally, each surgery will assess relevant aspects that are associated with 'getting older' and provide support in the coming months. The specific approaches are based on the Comprehensive Geriatric Assessment, the World Health Organisation's recommendation and resources for the Integrated Care of Older People (ICOPE) model, the recommendations from the International Conference of Frailty and Sarcopenia Research (ICFSR) and the Functional Fitness test battery. All of these approaches would lead to an 'personal care plan' developed by the medical student, with actions that are specific to the participant's circumstances.
- Conditions
- Frailty
- Being tested
- Frailty care pathway for older people in a rural primary care setting
- Keywords
- primary care, rural, intervention
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty care pathway for older people in a rural primary care settingOther
This intervention will take place in different primary care providers in a rural environment. Each provider will have one intervention and a no-intervention group, which will be part of the feasibility evaluation. The intervention will comprise a consultation with the participant, based on the different approaches described in the arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Geriatric Assessment (CGA) | Active comparator | Participants in this arm will undertake a Comprehensive Geriatric Assessment, and will be implemented based on Comprehensive Geriatric Assessment Toolkit for Primary Care Practitioners from the British Geriatrics Society. A personalised action plan will be developed and implemented based on the CGA. Receives: Other: Frailty care pathway for older people in a rural primary care setting |
| Integrated Care for Older PEople (ICOPE) | Experimental | Participants in this arm will undertake the assessment recommended by the World Health Organisation, and will be implemented by the publicly available app. A personalised action plan will be developed and implemented based on the ICOPE. Receives: Other: Frailty care pathway for older people in a rural primary care setting |
| Identification and Management of frailty and sarcopenia | Experimental | Participants in this arm will undertake the assessment recommended by the International Conference on Frailty and Sarcopenia Research Clinical Practice Guidelines for Identification and Management of physical frailty (ICFSR). A personalised action plan will be developed and implemented based on the ICFSR. Receives: Other: Frailty care pathway for older people in a rural primary care setting |
| Functional Fitness Battery (FFB) | Experimental | Participants in this arm will undertake a Functional Fitness Battery, comprising physical assessments on the intrinsic capacity, lifestyle and nutritional status Receives: Other: Frailty care pathway for older people in a rural primary care setting |
| Usual Care | No intervention | Participants in this arm will not receive an intervention, but the usual care provided by the primary care provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate (feasibility determination)
The recruitment rate reflects the recruitment method and number of eligible patients and general interest to take part.
Measured: 6 months
Drop out rate (feasibility determination)
The drop out rate reflects the number of participants lost to follow up, response rates and adherence/compliance to the intervention.
Measured: 12 months
Frequency of health care use
The number of hospital admissions and GP visits in the preceding 12 months
Measured: 12 months
electronic Frailty Index
This score reflects the number of accumulated deficits
Measured: 12 months
Secondary outcomes (3)
Physical Activity Level
Quantified by the International Physical Activity Questionnaire (IPAQ)
Measured: 12 months
Usual Walking Speed
The average speed of walking at a usual pace over a short distance of several meters
Measured: 12 months
Grip Strength
Maximal strength assessed using a hand held dynamometer
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Sep 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion30 May 2022 (estimated)
Why it stopped: COVID 19 caused delays for this project and is unlikely to be revisited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A feasibility trial employing a cluster randomized control trial design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aberystwyth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Arkesteijn, PhD, Principal investigator, Aberystwyth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849870
- Sponsor's protocol ID
- 16470
- Status last verified
- Jul 2020
- First submitted
- 28 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The project data will be made public via the Open Science Framework. This will include all IPD that underlie results in a publication
Publications
Dent E, Morley JE, Cruz-Jentoft AJ, Woodhouse L, Rodriguez-Manas L, Fried LP, Woo J, Aprahamian I, Sanford A, Lundy J, Landi F, Beilby J, Martin FC, Bauer JM, Ferrucci L, Merchant RA, Dong B, Arai H, Hoogendijk EO, Won CW, Abbatecola A, Cederholm T, Strandberg T, Gutierrez Robledo LM, Flicker L, Bhasin S, Aubertin-Leheudre M, Bischoff-Ferrari HA, Guralnik JM, Muscedere J, Pahor M, Ruiz J, Negm AM, Reginster JY, Waters DL, Vellas B. Physical Frailty: ICFSR International Clinical Practice Guidelines for Identification and Management. J Nutr Health Aging. 2019;23(9):771-787. doi: 10.1007/s12603-019-1273-z.
PubMed 31641726de Jong LD, Peters A, Hooper J, Chalmers N, Henderson C, Laventure RM, Skelton DA. The Functional Fitness MOT Test Battery for Older Adults: Protocol for a Mixed-Method Feasibility Study. JMIR Res Protoc. 2016 Jun 20;5(2):e108. doi: 10.2196/resprot.5682.
PubMed 27324114
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Frailty Care Pathways in Rural Primary Care: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05849870
- Acronym / sponsor ID
- 16470
- Conditions
- Frailty
- Keywords
- primary care, rural, intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID 19 caused delays for this project and is unlikely to be revisited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aberystwyth UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 9 May 2023 (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.
Primary Care General Practitioners (GPs) are always looking at ways to improve the care of older people and ways to prevent older people from losing their independence. Pro-active provision of support often involves lifestyle advice and is a potentially important aspect of that, as it supports older people before acute care is needed. It's preventative caring, rather than reactive caring. But, implementing pro-active care is hampered by the high current workload of acute care, the uncertainty of 'what works' and whether patients are responsive to pro-active care plans. This project will explore different ways of providing pro-active support to older people who could be at risk of losing their independence and requiring frequent acute care. The benefits of pro-active care are arguably the greatest in these individuals.
Detailed description
This is randomised control trial design with a cluster randomisation, whereby each cluster (a GP surgery) will have a different intervention. As it's a feasibility study, there will only be one cluster per intervention.
Participants will be recruited from 4 local primary care surgeries, and if participants take part, they will have 4 visits, and will be randomly allocation of an intervention arm, or a control arm receiving usual care.
At the start, the participant would have 2 visits of a maximum of 2 hours to the participant's local GP surgery to undergo a variety of tasks and assessments about the participant's well-being, health and physical functioning. That could lead to an 'action plan' that is implemented. The participant will have the 3rd visit after 3 months, and a final (fourth) visit after 12 months. During the 3rd and 4th visit the participant will repeat various tasks and assessments done in visit 1 and 2.
The project comprises different activities in the different GP surgeries. The project compares different approaches that each surgery takes. Generally, each surgery will assess relevant aspects that are associated with 'getting older' and provide support in the coming months. The specific approaches are based on the Comprehensive Geriatric Assessment, the World Health Organisation's recommendation and resources for the Integrated Care of Older People (ICOPE) model, the recommendations from the International Conference of Frailty and Sarcopenia Research (ICFSR) and the Functional Fitness test battery. All of these approaches would lead to an 'personal care plan' developed by the medical student, with actions that are specific to the participant's circumstances.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- A feasibility trial employing a cluster randomized control trial design.
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Geriatric Assessment (CGA) | Active comparator | Other: Frailty care pathway for older people in a rural primary care settingParticipants in this arm will undertake a Comprehensive Geriatric Assessment, and will be implemented based on Comprehensive Geriatric Assessment Toolkit for Primary Care Practitioners from the British Geriatrics Society. A personalised action plan will be developed and implemented based on the CGA. |
| Integrated Care for Older PEople (ICOPE) | Experimental | Other: Frailty care pathway for older people in a rural primary care settingParticipants in this arm will undertake the assessment recommended by the World Health Organisation, and will be implemented by the publicly available app. A personalised action plan will be developed and implemented based on the ICOPE. |
| Identification and Management of frailty and sarcopenia | Experimental | Other: Frailty care pathway for older people in a rural primary care settingParticipants in this arm will undertake the assessment recommended by the International Conference on Frailty and Sarcopenia Research Clinical Practice Guidelines for Identification and Management of physical frailty (ICFSR). A personalised action plan will be developed and implemented based on the ICFSR. |
| Functional Fitness Battery (FFB) | Experimental | Other: Frailty care pathway for older people in a rural primary care settingParticipants in this arm will undertake a Functional Fitness Battery, comprising physical assessments on the intrinsic capacity, lifestyle and nutritional status |
| Usual Care | No intervention | –Participants in this arm will not receive an intervention, but the usual care provided by the primary care provider. |
Who may qualify
- Ages
- 60 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adults aged 60 years or older
- mild frailty or frailty based on the eFI,
- without severe cognitive impairment diagnoses,
- not currently taking part in other research or in the previous 6 months,
- willing to provide informed consent
Key exclusion criteria (7 listed)
- are terminally ill
- have severe cognitive or psychological impairments,
- have experienced a severe, disabling stroke within the previous 6 months
- are unable to communicate in English.
- are currently taking part in other research project, or was part of research in the previous 6 months.
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 |
|---|---|---|
| Frailty care pathway for older people in a rural primary care settingThis intervention will take place in different primary care providers in a rural environment. Each provider will have one intervention and a no-intervention group, which will be part of the feasibility evaluation. The intervention will comprise a consultation with the participant, based on the different approaches described in the arm descriptions. | Other | Comprehensive Geriatric Assessment (CGA), Functional Fitness Battery (FFB), Identification and Management of frailty and sarcopenia, Integrated Care for Older PEople (ICOPE) |
Primary outcome
Recruitment rate (feasibility determination)
Time frame: 6 months
The recruitment rate reflects the recruitment method and number of eligible patients and general interest to take part.
Drop out rate (feasibility determination)
Time frame: 12 months
The drop out rate reflects the number of participants lost to follow up, response rates and adherence/compliance to the intervention.
Frequency of health care use
Time frame: 12 months
The number of hospital admissions and GP visits in the preceding 12 months
electronic Frailty Index
Time frame: 12 months
This score reflects the number of accumulated deficits
3 secondary outcomes
Physical Activity Level
Time frame: 12 months
Usual Walking Speed
Time frame: 12 months
Grip Strength
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 31641726Dent E, Morley JE, Cruz-Jentoft AJ, Woodhouse L, Rodriguez-Manas L, Fried LP, Woo J, Aprahamian I, Sanford A, Lundy J, Landi F, Beilby J, Martin FC, Bauer JM, Ferrucci L, Merchant RA, Dong B, Arai H, Hoogendijk EO, Won CW, Abbatecola A, Cederholm T, Strandberg T, Gutierrez Robledo LM, Flicker L, Bhasin S, Aubertin-Leheudre M, Bischoff-Ferrari HA, Guralnik JM, Muscedere J, Pahor M, Ruiz J, Negm AM, Reginster JY, Waters DL, Vellas B. Physical Frailty: ICFSR International Clinical Practice Guidelines for Identification and Management. J Nutr Health Aging. 2019;23(9):771-787. doi: 10.1007/s12603-019-1273-z.
- Background: PubMed 27324114de Jong LD, Peters A, Hooper J, Chalmers N, Henderson C, Laventure RM, Skelton DA. The Functional Fitness MOT Test Battery for Older Adults: Protocol for a Mixed-Method Feasibility Study. JMIR Res Protoc. 2016 Jun 20;5(2):e108. doi: 10.2196/resprot.5682.
- The CGA toolkit for primary care, used in one of the intervention armsLink provided by the sponsor.
- The ICOPE app, used in one of the intervention armsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The project data will be made public via the Open Science Framework. This will include all IPD that underlie results in a publication
Related trials for Frailty
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Not yet recruitingObservational study
Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites
Heart Valve Diseases, Cardiac Surgical Procedures
Active, not recruiting
Online Prehabilitation for Patients Awaiting Liver Transplantation
Cirrhosis, Liver, Liver Transplant Surgery
Active, not recruiting
Prehabilitation in Pancreatic Surgery
Pancreatic Cancer, Periampullary Cancer
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.
Marco Arkesteijn, PhD principal investigator
Aberystwyth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frailty care pathway for older people in a rural primary care setting in people with Frailty, run by Aberystwyth 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 5 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: withdrawn, as of the sponsor's last update on 9 May 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Recruitment rate (feasibility determination) (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT05849870, which also lists 2 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 9 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.