An interventional study of Frailty care pathway for older people in a rural primary care setting in Frailty, sponsored by Aberystwyth University. Withdrawn at 1 site in United Kingdom. Open to participants aged 60 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Aberystwyth University · Not applicable, Interventional, and Prevention
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.
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.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
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The study focuses on community-dwelling frail older people (≥ 60 years). Each GP surgery will complete the electronic Frailty Index (eFI) to stratify older people based on their level of frailty (non-frail, mildly frail, and frail). Participants will be stratified into four strata,
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Frailty care pathway for older people in a rural primary care setting
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.
Other: Frailty care pathway for older people in a rural primary care setting
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.
Other: Frailty care pathway for older people in a rural primary care setting
Participants in this arm will undertake a Functional Fitness Battery, comprising physical assessments on the intrinsic capacity, lifestyle and nutritional status
Other: Frailty care pathway for older people in a rural primary care setting
Participants in this arm will not receive an intervention, but the usual care provided by the primary care provider.
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.
Recruitment rate (feasibility determination)
The recruitment rate reflects the recruitment method and number of eligible patients and general interest to take part.
Time frame: 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.
Time frame: 12 months
Frequency of health care use
The number of hospital admissions and GP visits in the preceding 12 months
Time frame: 12 months
electronic Frailty Index
This score reflects the number of accumulated deficits
Time frame: 12 months
Physical Activity Level
Quantified by the International Physical Activity Questionnaire (IPAQ)
Time frame: 12 months
Usual Walking Speed
The average speed of walking at a usual pace over a short distance of several meters
Time frame: 12 months
Grip Strength
Maximal strength assessed using a hand held dynamometer
Time frame: 12 months
Plan to share: Yes — The project data will be made public via the Open Science Framework. This will include all IPD that underlie results in a publication
Supporting information: Study protocol, Clinical study report
Time frame: By december 2022, final data set will be made available comprising the primary and secondary outcome variables, potential other variables collected as part of the intervention arms.
Data sharing details ↗ · osf.io
This study is withdrawn, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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