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

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05849870
• Other study ID #: 16470
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: July 2020
• Source: Aberystwyth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Frailty

Intervention

Other:
• Frailty care pathway for older people in a rural primary care setting
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.

Locations

Country	Name	City	State
United Kingdom	Aberystwyth University	Aberystwyth	Ceredigion

Sponsors (1)

Lead Sponsor	Collaborator
Aberystwyth University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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

Outcome

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

External Links

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