- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03394534
Comprehensive Geriatric Assessment in Primary Care: A Randomised Feasibility Trial
May 17, 2022 updated by: Reza Safari, University of Derby
'Comprehensive Geriatric Assessment' for Older Adults With Frailty Within Primary Care Setting: A Randomised Feasibility Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Derby, United Kingdom, DE22 1GB
- University of Derby
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 95 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Treatment as Usual
|
|
Experimental: CGA group
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CGA Plus Individualised Care and Support Plan delivered by Advanced Clinical Practitioner (ACP)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospitalisation and Nursing Home Admissions
Time Frame: at 6 months post intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Status
Time Frame: at baseline and 6 months post intervention
|
Improve Patient functional ability measured using Functional Independence Measure (FIM) questionnaire total score
|
at baseline and 6 months post intervention
|
Loneliness
Time Frame: at baseline and 6 months post intervention
|
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
|
Health related Quality of Life
Time Frame: at baseline and 6 months post intervention
|
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
|
Number of 999 calls and A+E attendance during the 6 months period
Time Frame: at 6 months post intervention
|
at 6 months post intervention
|
|
Length of time spent on A+E during the 6 months period
Time Frame: at 6 months post intervention
|
at 6 months post intervention
|
|
Length of time stayed in hospital or care home during the 6 months period
Time Frame: at 6 months post intervention
|
at 6 months post intervention
|
|
Therapist and staff time spent on CGA during the 6 months period
Time Frame: at 6 months post intervention
|
at 6 months post intervention
|
|
Number of GP/GP out of office attendance (including calls to GP) during the 6 months period
Time Frame: at 6 months post intervention
|
at 6 months post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Reza Safari, PhD, University of Derby
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2019
Primary Completion (Actual)
June 15, 2019
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
December 18, 2017
First Submitted That Met QC Criteria
January 8, 2018
First Posted (Actual)
January 9, 2018
Study Record Updates
Last Update Posted (Actual)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 17, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- v3.6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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