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

Primary Purpose

Frailty

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Frailty care pathway for older people in a rural primary care setting
Sponsored by
Aberystwyth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty focused on measuring primary care, rural, intervention

Eligibility Criteria

60 Years - 105 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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: 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

Sites / Locations

  • Aberystwyth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

No Intervention

Arm Label

Comprehensive Geriatric Assessment (CGA)

Integrated Care for Older PEople (ICOPE)

Identification and Management of frailty and sarcopenia

Functional Fitness Battery (FFB)

Usual Care

Arm Description

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.

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.

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.

Participants in this arm will undertake a Functional Fitness Battery, comprising physical assessments on the intrinsic capacity, lifestyle and nutritional status

Participants in this arm will not receive an intervention, but the usual care provided by the primary care provider.

Outcomes

Primary Outcome Measures

Recruitment rate (feasibility determination)
The recruitment rate reflects the recruitment method and number of eligible patients and general interest to take part.
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.
Frequency of health care use
The number of hospital admissions and GP visits in the preceding 12 months
electronic Frailty Index
This score reflects the number of accumulated deficits

Secondary Outcome Measures

Physical Activity Level
Quantified by the International Physical Activity Questionnaire (IPAQ)
Usual Walking Speed
The average speed of walking at a usual pace over a short distance of several meters
Grip Strength
Maximal strength assessed using a hand held dynamometer

Full Information

First Posted
April 28, 2023
Last Updated
April 28, 2023
Sponsor
Aberystwyth University
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1. Study Identification

Unique Protocol Identification Number
NCT05849870
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
COVID 19 caused delays for this project and is unlikely to be revisited.
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aberystwyth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
primary care, rural, intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A feasibility trial employing a cluster randomized control trial design.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive Geriatric Assessment (CGA)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Integrated Care for Older PEople (ICOPE)
Arm Type
Experimental
Arm Description
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.
Arm Title
Identification and Management of frailty and sarcopenia
Arm Type
Experimental
Arm Description
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.
Arm Title
Functional Fitness Battery (FFB)
Arm Type
Experimental
Arm Description
Participants in this arm will undertake a Functional Fitness Battery, comprising physical assessments on the intrinsic capacity, lifestyle and nutritional status
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants in this arm will not receive an intervention, but the usual care provided by the primary care provider.
Intervention Type
Other
Intervention Name(s)
Frailty care pathway for older people in a rural primary care setting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate (feasibility determination)
Description
The recruitment rate reflects the recruitment method and number of eligible patients and general interest to take part.
Time Frame
6 months
Title
Drop out rate (feasibility determination)
Description
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
Title
Frequency of health care use
Description
The number of hospital admissions and GP visits in the preceding 12 months
Time Frame
12 months
Title
electronic Frailty Index
Description
This score reflects the number of accumulated deficits
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Physical Activity Level
Description
Quantified by the International Physical Activity Questionnaire (IPAQ)
Time Frame
12 months
Title
Usual Walking Speed
Description
The average speed of walking at a usual pace over a short distance of several meters
Time Frame
12 months
Title
Grip Strength
Description
Maximal strength assessed using a hand held dynamometer
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Arkesteijn, PhD
Organizational Affiliation
Aberystwyth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aberystwyth University
City
Aberystwyth
State/Province
Ceredigion
ZIP/Postal Code
SY23 3FD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The project data will be made public via the Open Science Framework. This will include all IPD that underlie results in a publication
IPD Sharing 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.
IPD Sharing URL
https://osf.io/exac7/?view_only=078714fc84394ec08617dde4a6910457
Citations:
PubMed Identifier
31641726
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.
Results Reference
background
PubMed Identifier
27324114
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.
Results Reference
background
Links:
URL
https://www.bgs.org.uk/resources/resource-series/comprehensive-geriatric-assessment-toolkit-for-primary-care-practitioners
Description
The CGA toolkit for primary care, used in one of the intervention arms
URL
https://play.google.com/store/apps/details?id=com.universaltools.icope&hl=en_GB
Description
The ICOPE app, used in one of the intervention arms

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

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