Clinical trial NCT05849870: Comparing Frailty Care Pathways in Rural Primary Care: a Feasibility Study
Official title: Comparing Frailty Care Pathways in Rural Primary Care: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Frailty
Keywords: primary care
rural
intervention
Lead sponsor: Aberystwyth University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A feasibility trial employing a cluster randomized control trial design.
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate (feasibility determination)
timeFrame: 6 months
measure: Drop out rate (feasibility determination)
timeFrame: 12 months
measure: Frequency of health care use
timeFrame: 12 months
measure: electronic Frailty Index
timeFrame: 12 months
Secondary outcomes:
measure: Physical Activity Level
timeFrame: 12 months
measure: Usual Walking Speed
timeFrame: 12 months
measure: Grip Strength
timeFrame: 12 months
Other outcomes:
Locations:
city: Aberystwyth
country: United Kingdom
facility: Aberystwyth University
state: Ceredigion
Study officials:
affiliation: Aberystwyth University
name: Marco Arkesteijn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.