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Comprehensive Geriatric Assessment in Primary Care: A Randomised Feasibility Trial

Primary Purpose

Frailty

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CGA group
Sponsored by
University of Derby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Frailty focused on measuring Comprehensive Geriatric Assessment, Frailty, electronic Frailty Index, eFI, Care and Support plan, Primary Care

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Derby

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CGA group

Treatment as Usual

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional Status
Improve Patient functional ability measured using Functional Independence Measure (FIM) questionnaire total score
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.
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.
Number of 999 calls and A+E attendance during the 6 months period
Length of time spent on A+E during the 6 months period
Length of time stayed in hospital or care home during the 6 months period
Therapist and staff time spent on CGA during the 6 months period
Number of GP/GP out of office attendance (including calls to GP) during the 6 months period

Full Information

First Posted
December 18, 2017
Last Updated
May 17, 2022
Sponsor
University of Derby
Collaborators
Derbyshire Clinical Commissioning Groups
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1. Study Identification

Unique Protocol Identification Number
NCT03394534
Brief Title
Comprehensive Geriatric Assessment in Primary Care: A Randomised Feasibility Trial
Official Title
'Comprehensive Geriatric Assessment' for Older Adults With Frailty Within Primary Care Setting: A Randomised Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Derby
Collaborators
Derbyshire Clinical Commissioning Groups

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
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: To assess applicability of finding older adults with frailty using eFI and delivering subsequent CGA and care planning at patients' home To investigate staff and older adults' perception of CGA programme To assess the health care resource usage and cost of the CGA programme To measure key health related outcome domains including function, quality of life, loneliness, pain, falls and mobility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
Comprehensive Geriatric Assessment, Frailty, electronic Frailty Index, eFI, Care and Support plan, Primary Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CGA group
Arm Type
Experimental
Arm Title
Treatment as Usual
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
CGA group
Intervention Description
CGA Plus Individualised Care and Support Plan delivered by Advanced Clinical Practitioner (ACP)
Primary Outcome Measure Information:
Title
Hospitalisation and Nursing Home Admissions
Description
Number of hospital and/or care home admissions during the 6 months period and reported in terms of admitted v. not admitted
Time Frame
at 6 months post intervention
Secondary Outcome Measure Information:
Title
Functional Status
Description
Improve Patient functional ability measured using Functional Independence Measure (FIM) questionnaire total score
Time Frame
at baseline and 6 months post intervention
Title
Loneliness
Description
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.
Time Frame
at baseline and 6 months post intervention
Title
Health related Quality of Life
Description
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.
Time Frame
at baseline and 6 months post intervention
Title
Number of 999 calls and A+E attendance during the 6 months period
Time Frame
at 6 months post intervention
Title
Length of time spent on A+E during the 6 months period
Time Frame
at 6 months post intervention
Title
Length of time stayed in hospital or care home during the 6 months period
Time Frame
at 6 months post intervention
Title
Therapist and staff time spent on CGA during the 6 months period
Time Frame
at 6 months post intervention
Title
Number of GP/GP out of office attendance (including calls to GP) during the 6 months period
Time Frame
at 6 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Safari, PhD
Organizational Affiliation
University of Derby
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Derby
City
Derby
ZIP/Postal Code
DE22 1GB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23666405
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.
Results Reference
background
PubMed Identifier
23395245
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. Erratum In: Lancet. 2013 Oct 19;382(9901):1328.
Results Reference
background
PubMed Identifier
26941353
Citation
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
25355618
Citation
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.
Results Reference
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Comprehensive Geriatric Assessment in Primary Care: A Randomised Feasibility Trial

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