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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03394534
Other study ID # v3.6
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date September 30, 2021

Study information

Verified date May 2022
Source University of Derby
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to explore feasibility of implementing a tailored CGA to older adults with frailty and evaluate staff and patients perception of the intervention. In line with this, the objectives of the study are: 1. To assess applicability of finding older adults with frailty using eFI and delivering subsequent CGA and care planning at patients' home 2. To investigate staff and older adults' perception of CGA programme 3. To assess the health care resource usage and cost of the CGA programme 4. To measure key health related outcome domains including function, quality of life, loneliness, pain, falls and mobility.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date September 30, 2021
Est. primary completion date June 15, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years to 95 Years
Eligibility Inclusion Criteria: - Age 65 to 95 years - eFI score > 0.12 Exclusion Criteria: - Do not meet criteria for frailty based on Gait speed, timed up and go test and PRISMA questionnaire

Study Design


Related Conditions & MeSH terms


Intervention

Other:
CGA group
CGA Plus Individualised Care and Support Plan delivered by Advanced Clinical Practitioner (ACP)

Locations

Country Name City State
United Kingdom University of Derby Derby

Sponsors (2)

Lead Sponsor Collaborator
University of Derby Derbyshire Clinical Commissioning Groups

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

Clegg A, Rogers L, Young J. Diagnostic test accuracy of simple instruments for identifying frailty in community-dwelling older people: a systematic review. Age Ageing. 2015 Jan;44(1):148-52. doi: 10.1093/ageing/afu157. Epub 2014 Oct 29. Review. — View Citation

Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8. Review. Erratum in: Lancet. 2013 Oct 19;382(9901):1328. — View Citation

Edmans J, Bradshaw L, Gladman JR, Franklin M, Berdunov V, Elliott R, Conroy SP. The Identification of Seniors at Risk (ISAR) score to predict clinical outcomes and health service costs in older people discharged from UK acute medical units. Age Ageing. 2013 Nov;42(6):747-53. doi: 10.1093/ageing/aft054. Epub 2013 May 10. — View Citation

Fit for Frailty - Developing, commissioning and managing services for people living with frailty in community settings - a report from the British Geriatrics Society and the Royal College of General Practitioners 2015.

Gladman JR, Conroy SP, Ranhoff AH, Gordon AL. New horizons in the implementation and research of comprehensive geriatric assessment: knowing, doing and the 'know-do' gap. Age Ageing. 2016 Mar;45(2):194-200. doi: 10.1093/ageing/afw012. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hospitalisation and Nursing Home Admissions Number of hospital and/or care home admissions during the 6 months period and reported in terms of admitted v. not admitted at 6 months post intervention
Secondary Functional Status Improve Patient functional ability measured using Functional Independence Measure (FIM) questionnaire total score at baseline and 6 months post intervention
Secondary Loneliness Improve overall, emotional, and social loneliness calculated using the De Jong Gierveld Loneliness Scale total score. The scale is used to assess subjective perception of social participation or isolation in elderly adults. at baseline and 6 months post intervention
Secondary Health related Quality of Life Change in health related quality of life calculated using the 36-Item Short Form Survey (SF-36). The Sf-36 is patient reported outcome measure with a set of generic quality of life measures including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health subscales. at baseline and 6 months post intervention
Secondary Number of 999 calls and A+E attendance during the 6 months period at 6 months post intervention
Secondary Length of time spent on A+E during the 6 months period at 6 months post intervention
Secondary Length of time stayed in hospital or care home during the 6 months period at 6 months post intervention
Secondary Therapist and staff time spent on CGA during the 6 months period at 6 months post intervention
Secondary Number of GP/GP out of office attendance (including calls to GP) during the 6 months period at 6 months post intervention
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