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Comprehensive Geriatric Assessment in Primary Care: A Randomised Feasibility Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394534
Recruitment Status : Unknown
Verified April 2018 by Reza Safari, University of Derby.
Recruitment status was:  Recruiting
First Posted : January 9, 2018
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Derbyshire Clinical Commissioning Groups
Information provided by (Responsible Party):
Reza Safari, University of Derby

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:

  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.

Condition or disease Intervention/treatment Phase
Frailty Other: CGA group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 'Comprehensive Geriatric Assessment' for Older Adults With Frailty Within Primary Care Setting: A Randomised Feasibility Trial
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: CGA group Other: CGA group
CGA Plus Individualised Care and Support Plan delivered by Advanced Clinical Practitioner (ACP)

No Intervention: Treatment as Usual



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Functional Status [ Time Frame: at baseline and 6 months post intervention ]
    Improve Patient functional ability measured using Functional Independence Measure (FIM) questionnaire total score

  2. 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.

  3. 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.

  4. Number of 999 calls and A+E attendance during the 6 months period [ Time Frame: at 6 months post intervention ]
  5. Length of time spent on A+E during the 6 months period [ Time Frame: at 6 months post intervention ]
  6. Length of time stayed in hospital or care home during the 6 months period [ Time Frame: at 6 months post intervention ]
  7. Therapist and staff time spent on CGA during the 6 months period [ Time Frame: at 6 months post intervention ]
  8. Number of GP/GP out of office attendance (including calls to GP) during the 6 months period [ Time Frame: at 6 months post intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394534


Contacts
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Contact: Reza Safari, PhD +44(0)1332 592418 m.safari@derby.ac.uk

Locations
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United Kingdom
University of Derby Recruiting
Derby, United Kingdom, DE22 1GB
Contact: Reza Safari    01332592418    m.safari@derby.ac.uk   
Sponsors and Collaborators
University of Derby
Derbyshire Clinical Commissioning Groups
Investigators
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Principal Investigator: Reza Safari, PhD University of Derby
Publications:
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Responsible Party: Reza Safari, Research Fellow, University of Derby
ClinicalTrials.gov Identifier: NCT03394534    
Other Study ID Numbers: v3.6
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Reza Safari, University of Derby:
Comprehensive Geriatric Assessment
Frailty
electronic Frailty Index
eFI
Care and Support plan
Primary Care
Additional relevant MeSH terms:
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Frailty
Pathologic Processes