The effectiveness of a new intervention for older people living with frailty
| ISRCTN | ISRCTN10613839 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10613839 |
| IRAS number | 250981 |
| Secondary identifying numbers | IRAS 250981 |
- Submission date
- 29/07/2022
- Registration date
- 01/08/2022
- Last edited
- 09/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
The number of older people is increasing and this is leading to a rise in the number of people living with multiple illnesses at the same time. Some symptoms and concerns are particularly neglected in this population, such as breathlessness (which frequently leads to admission to hospital), unintentional weight loss (which increases frailty), pain medicines use and possible adverse effects. A new service has been developed in Hull to redesign care of older frail people, through a new Integrated Care Centre and within care homes. This is because current care pathways are not always the optimal way to deliver care to older people with multiple illnesses. However, this new service needs evaluation to find out if it improves the well-being and health status of older people or not. This study will assess the effectiveness of this new service.
Who can participate?
People aged 65 years and above identified to be at risk of severe frailty
What does the study involve?
The researchers will compare the health status and quality of life of people receiving the new service with a matched group not receiving the service. They will assess if health status and quality of life are better in those with the new service or not.
What are the possible benefits and risks of participating?
It is unlikely that there will be any direct personal benefit in taking part. However, the information provided will help decide if overall health and well-being have been improved by using this new service and give the researchers ways to improve this service in the future. There is no significant risk in taking part, other than the time the study will take.
Where is the study run from?
University of Hull (UK)
When is the study starting and how long is it expected to run for?
October 2018 to December 2022
Who is funding the study?
University of Hull (UK)
Who is the main contact?
Prof. Fliss Murtagh, fliss.murtagh@hyms.ac.uk
Contact information
Principal Investigator
Allam Medical Building
University of Hull
Hull
HU6 7RX
United Kingdom
 ORCID ID |
0000-0003-1289-3726 |
|---|---|
| Phone | +44 (0)1482 463309 |
| fliss.murtagh@hyms.ac.uk |
Study information
| Study design | Community-based non-randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | 42153_PIS_08Jan19_V3.pdf |
| Scientific title | A non-randomised controlled study to assess the effectiveness of a new proactive multidisciplinary care intervention for older people living with frailty |
| Study hypothesis | A new, anticipatory, multidisciplinary care service is effective at improving the wellbeing and quality of life (QoL) of older people living with severe frailty. |
| Ethics approval(s) | Approved 24/01/2019, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 1048 088; nrescommittee.yorkandhumber-bradfordleeds@nhs.net), ref: 18/YH/0470 |
| Condition | Older people living with severe frailty |
| Intervention | The new, anticipatory, multidisciplinary care service includes interventions by a multidisciplinary team of geriatricians, nurse practitioners, general practitioners with an extended role in frailty care, pharmacists, occupational therapists, physiotherapists, social workers, clinical support workers, carers’ support, and volunteers. The intervention provided by this new service consists of individually-tailored assessments during a single appointment, taking approximately 3-5 hours. Assessments are based on the individual's comprehensive geriatric assessment and individualised care needs. All participants receive personalised care planning, physical health review, assessment of psychological wellbeing/mental health, medication review, social needs review, and functional/therapy review. Participants are also encouraged to discuss the ReSPECT (Recommended Summary Plan for Emergency Care and Treatment) form, a tool completed by professionals to promote advance care planning and individualised recommendations for a person's future clinical treatment. |
| Intervention type | Other |
| Primary outcome measure | Wellbeing measured by the Integrated Palliative care Outcome Scale (IPOS) at baseline, 2-4 weeks, and 10-14 weeks |
| Secondary outcome measures | Quality of life measured by EQ-5D-5L at baseline, 2-4 weeks, and 10-14 weeks |
| Overall study start date | 01/10/2018 |
| Overall study end date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | The clinical minimally important difference in the primary outcome (IPOS total score) is 4.8, with the mean (SD) for the baseline IPOS of 27.4 (9.3) (IPOS validation study; personal communication, Ramsenthaler, 2018). To achieve 90% power at 5% significance level, 80 patients in each group are therefore required. Allowing for 50% attrition at the 2-4 week follow-up, the sample size is inflated to 160 per group. |
| Total final enrolment | 253 |
| Participant inclusion criteria | 1. Aged 65 years and above 2. Identified to be at risk of severe frailty (electronic Frailty Index [eFI score ≥0.36]) |
| Participant exclusion criteria | 1. Aged less than 65 years 2. Electronic Frailty Index <0.36 3. Unable to consent |
| Recruitment start date | 01/04/2019 |
| Recruitment end date | 31/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hull
HU9 2BL
United Kingdom
Sponsor information
University/education
Cottingham Road
Hull
HU6 7RX
England
United Kingdom
| Phone | +44 (0)1482346311 |
|---|---|
| K.Skilton@hull.ac.uk | |
| Website | http://www2.hull.ac.uk/ |
"ROR" |
https://ror.org/04nkhwh30 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- HU
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | It is not expected that participant-level data would be made public due to confidentiality. However, The University of Hull will keep identifiable information about participants for 10 years after the study has finished. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 08/01/2019 | 29/07/2022 | No | Yes |
| Results article | Primary results | 05/01/2023 | 09/01/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
09/01/2023: The following changes were made to the trial record:
1. Publication reference added.
2. The intention to publish date was changed from 31/01/2023 to 05/01/2023.
19/12/2022: The intention to publish date was changed from 01/01/2023 to 31/01/2023.
24/11/2022: The intention to publish date was changed from 01/11/2022 to 01/01/2023.
14/10/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/08/2022 to 31/12/2022.
2. The intention to publish date
3. The plain English summary was updated to reflect these changes.
29/07/2022: Trial's existence confirmed by the Yorkshire & The Humber - Bradford Leeds Research Ethics Committee.
