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Completed

NCT Number: NCT03394534

Comprehensive Geriatric Assessment in Primary Care: 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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Derby

Derby, DE22 1GB, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CGA group

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Derby

Other

Collaborators

  • Derbyshire Clinical Commissioning Groups

Registry information

Official study title

'Comprehensive Geriatric Assessment' for Older Adults With Frailty Within Primary Care Setting: A Randomised Feasibility Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Jan 9, 2018
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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