Frailty Clinical Trial
Official title:
Comparing Frailty Care Pathways in Rural Primary Care: a Feasibility Study
NCT number | NCT05849870 |
Other study ID # | 16470 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2021 |
Est. completion date | May 30, 2022 |
Verified date | July 2020 |
Source | Aberystwyth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 30, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 105 Years |
Eligibility | 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, - participants without complex care needs and with a relatively low frailty level (non-frail); - participants with some chronic conditions that could put them at risk in the future (mild frailty) - frail participants at risk of complex care needs (frailty) - participants with complex care needs (severe frailty). Inclusion Criteria: - 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 Exclusion Criteria: 1. are terminally ill 2. have severe cognitive or psychological impairments, 3. have experienced a severe, disabling stroke within the previous 6 months 4. are unable to communicate in English. 5. are currently taking part in other research project, or was part of research in the previous 6 months. 6. have experienced a heart attack, or unstable angina within the previous 3 months. 7. 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Aberystwyth University | Aberystwyth | Ceredigion |
Lead Sponsor | Collaborator |
---|---|
Aberystwyth University |
United Kingdom,
de 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rate (feasibility determination) | The recruitment rate reflects the recruitment method and number of eligible patients and general interest to take part. | 6 months | |
Primary | 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. | 12 months | |
Primary | Frequency of health care use | The number of hospital admissions and GP visits in the preceding 12 months | 12 months | |
Primary | electronic Frailty Index | This score reflects the number of accumulated deficits | 12 months | |
Secondary | Physical Activity Level | Quantified by the International Physical Activity Questionnaire (IPAQ) | 12 months | |
Secondary | Usual Walking Speed | The average speed of walking at a usual pace over a short distance of several meters | 12 months | |
Secondary | Grip Strength | Maximal strength assessed using a hand held dynamometer | 12 months |
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