Comparing Frailty Care Pathways in Rural Primary Care: a Feasibility Study

NCT05849870 | Withdrawn

• 1 other identifier: 16470
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Keywords

primary care; rural; intervention

Outcome Measures

Primary Outcomes (4)

• Recruitment rate (feasibility determination)

  The recruitment rate reflects the recruitment method and number of eligible patients and general interest to take part.

  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.

  12 months

• Frequency of health care use

  The number of hospital admissions and GP visits in the preceding 12 months

  12 months

• electronic Frailty Index

  This score reflects the number of accumulated deficits

  12 months

Secondary Outcomes (3)

• Physical Activity Level

  12 months

• Usual Walking Speed

  12 months

• Grip Strength

  12 months

Study Arms (5)

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.

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.

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.

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

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.

Interventions

Frailty care pathway for older people in a rural primary care setting OTHER

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.

Comprehensive Geriatric Assessment (CGA); Functional Fitness Battery (FFB); Identification and Management of frailty and sarcopenia; Integrated Care for Older PEople (ICOPE)

Eligibility Criteria

• Age: 60 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aberystwyth University: lead

Study Sites (1)

Aberystwyth University

Aberystwyth, Ceredigion, SY23 3FD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 31641726 BACKGROUND

• 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.

  PMID: 27324114 BACKGROUND

Related Links

• The CGA toolkit for primary care, used in one of the intervention arms
• The ICOPE app, used in one of the intervention arms

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Arkesteijn, PhD

  Aberystwyth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There will be different people assigned to the delivery and the intervention. The effectiveness of this will be established as part of the feasibility evaluation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A feasibility trial employing a cluster randomized control trial design.

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: September 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: May 30, 2022
• Last Updated: May 9, 2023

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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.

Locations

GB (1)