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:

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

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

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.

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.

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

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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