Frailty in older people Signs and Symptoms Frailty
Conditions
Interventions
This study is a cluster randomised controlled trial to test the feasibility of conducting a larger scale definitive cluster randomised trial. The PCP intervention will be applied across a whole 'clust
Sponsors
Bradford Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients 1. Aged 65 years or older 2. eFI (Electronic Frailty Index) score of 0.21 or above GP Practice 1. Use any of the following electronic health care record systems: SystmOne, EMIS, Vision, Microtest 2. Within a reasonable geographical area to allow intervention team supervision 3. Have the structure and resources necessary and willing to deliver the intervention (eg MDT type meetings every 4-6 weeks) 4. Not have an existing or planned personalised care planning service with an element of targeting older people with frailty Carers 1. Participant or their consultee has consented to the carer’s involvement in the study 2. Has capacity to provide written informed consent
Exclusion criteria
Exclusion criteria: Participant: 1. Care home resident at the time of screening 2. Registered on the gold standards framework 3. Severe dementia (Montreal Cognitive Assessment score <10) GP Practice: 1. Existing PCP service with an element of targeting older people with frailty and some overlap with Age UK model framework 2. Plans to implement a PCP service with an element of targeting older people with frailty and some overlap with Age UK model framework during the study recruitment period. Carer: 1. Lacks capacity to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the trial - a progression check 12 months after starting recruitment: 1. Recruitment, assessed by the mean number of participants registered per site at 12 months post-recruitment 2. Intervention delivery - the percentage of participants in the intervention arm receiving at least 2 intervention visits, assessed using case report form (CRF) return at 12 months post-recruitment 3. Follow-up - the percentage of participants returning a completed SF36 questionnaire 6 months post-registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility of the trial, assessed 12 months post-recruitment using the following information: 1. Number of general practices expressing an interest in participating, number of practices completing a site feasibility questionnaire (SFQ), method of initial contact and reasons for not returning SFQ 2. Number (%) of general practices screened, identified as eligible, and randomised, and reasons for non-selection 3. Number (%) of general practices completing the trial 4. Number (%) of and timing of general practice withdrawals from follow-up, reasons for withdrawal 5. Establish the extent to which blinding of practice staff and researchers to allocation can be maintained. 6. Number of patients screened for eligibility and number excluded 7. Number (%) of eligible participants consenting to participation in the trial 8. Number (%) of registered patients completing the trial 9. Number (%) of and timing of patient withdrawals and losses to follow-up, reasons for withdrawal 10. Mean and variability of self-reported patient outcome measures at baseline and 12 months 11. Mean and variability of SF-36 PCS and MCS scores and the corresponding derived SF-12 scores, the proposed primary outcome for the definitive RCT. 12. Clustering effect (ICC – intracluster correlation coefficient) and 95% CI relating to SF-36/SF-12 13. Difference (and 95% CI) in self-reported patient outcomes at 12 months between arms 14. Establishment of processes for successful collection of routine data, in particular primary care resource data, secondary care HES data and mortality data 15. Number (%) of participants with self-reported outcome data at each time point 16. Number (%) of participants for whom it was possible to collect routine data | — |
Countries
England, United Kingdom
Contacts
Public ContactCatriona Parker
Outcome results
None listed