The Yorkshire & Humber community ageing research study

Not Applicable

Completed

• Conditions: Signs and Symptoms; Older people (>75 years) with and without frailty; Frailty

• Registration Number: ISRCTN16588124
• Lead Sponsor: Bradford Teaching Hospitals Foundation Trust

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30850418 protocol (added 23/03/2020) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30321256/ results (added 25/02/2021) 2016 Other publications in https://doi.org/10.1186/s40900-016-0044-9 (added 14/06/2023) 2021 Results article in http://dx.doi.org/10.1136/bmjopen-2020-048524 (added 14/06/2023) 2020 Results article in https://doi.org/10.1371/journal.pone.0243972 (added 14/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-06
• Study Completion: 2019-09-30
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 353

Inclusion Criteria

Current participant inclusion criteria as of 03/05/2018:
1. Aged 75 years or older
2. Live in community
3. Identified as fit and or with mild, moderate and severe frailty (for pilot phase and main study)

Previous inclusion criteria:
1. Aged 75 years or older
2. Live in community
3. Identified as fit and or with mild, moderate and severe frailty (for pilot phase)
4. Mild, moderate and severe frailty (for main study)
The first 200 participants will be older people (>75 years) with and without frailty. The next 800 participants will be older people (>75 years) with frailty.

Exclusion Criteria

1. Care home residents and people living at home who are bedbound
2. People with terminal cancer,
3. Those in receipt of the Amber Care Bundle (estimated life expectancy of three months or less) 4. People in receipt of palliative care services will also be excluded.

Note – if participants go into a care home/nursing home after they have undertaken their initial baseline assessment, they will not be excluded and can continue if they are still willing to do so.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The minimum dataset required for the CARE study has been established on the basis of expert consensus, with due consideration of the cmRCT design and the range of primary outcomes required for future trials. For primary outcomes, we have therefore included:<br>1. Basic activities of daily living (ADL) (Barthel index)<br>2. Instrumental ADL (Notting Extended Activities of Daily Living)<br>3. Frailty (measured using phenotype model & cumulative deficit model)<br>4. Health-related quality of life (EQ5D)<br>5. General health (SF36)<br>6. Pain (geriatric pain measure)<br>7. Depression (geriatric depression scale)<br>8. Loneliness (de Jong Gierveld loneliness scale)<br><br>All assessments will be undertaken at baseline (timepoint 1), 6 months (time point 2), 12 months (timepoint 3), 24 months (timepoint 4), 48 months (timepoint 5).

Secondary Outcome Measures

Name	Time	Method
1. Health and social care resource use<br>2. Care home admission<br>3. Mortality<br>4. Cognition (Montreal Cognitive Assessment)<br>5. Hand grip strength assessment<br>6. Gait speed<br>7. Timed Up and Go test<br>8. Falls (self-report)<br><br>All assessments will be undertaken at baseline (timepoint 1), 6 months (time point 2), 12 months (timepoint 3), 24 months (timepoint 4), 48 months (timepoint 5).