Condition category
Not Applicable
Date applied
18/08/2020
Date assigned
28/08/2020
Last edited
28/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Frailty is a condition that affects one in ten people over the age of 65 and can mean they are at higher risk of falls, disability, hospital and care home admission and poorer quality of life. As the population ages, frailty also impacts on health and social care services. Care for older adults should be proactive and person-centred rather than focused on different diseases and personalised care planning or PCP is one way to deliver person-centred care. Researchers have developed a PCP intervention called PROSPER that aims to improve the quality of life of older adults with frailty and also reduce the burden on health and social care systems.

Who can participate?
People aged 65 or older and identified as having some signs of frailty by their GP records

What does the study involve?
A researcher will visit participants in their own home to describe the trial and answer any questions. If people are happy to take part the researchers will ask them to fill in some questionnaires about their quality of life. Participants will then be randomly divided into two groups – intervention and usual care. Participants in the intervention group will be contacted by a Personal Independence Coordinator from Age UK who will work with them for 12 weeks to help improve their wellbeing and self-management skills. Participants in the usual care group will carry on as normal. Everyone will be asked to complete the questionnaires again at 6 and 12 months after they started the study.

What are the possible benefits and risks of participating?
Participants in the intervention group may experience improved physical and mental health.

Where is the study run from?
The study is run by researchers from the Academic Unit of Ageing & Stroke Research at the Bradford Institute for Health Research and the Clinical Trials Research Unit at the University of Leeds

When is the study starting and how long is it expected to run for?
September 2019 to March 2023

Who is funding the study?
National Institute for Health Research Programme Grant for Applied Research (UK)

Who is the main contact?
The study team can be contacted via PROSPER@leeds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Catriona Parker

ORCID ID

http://orcid.org/0000-0002-3826-2554

Contact details

CTRU
University of Leeds
Leeds
LS2 9JT
United Kingdom
+44 (0)113 343 9241
Prosper@leeds.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 43820, IRAS 270305

Study information

Scientific title

PROSPER: A definitive, multi-site, individually randomised controlled trial of PeRsOnaliSed care Planning for oldER people with frailty

Acronym

PROSPER Definitive v1.0

Study hypothesis

Personalised care planning (PCP) improves the quality of life of older people with frailty.

Ethics approval

Approved 07/05/2020, Yorkshire & The Humber – Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8083; bradfordleeds.rec@hra.nhs.uk), REC ref: 20/YH/0108

Study design

Interventional randomized controlled trial with embedded qualitative evaluation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Older people with frailty

Intervention

The study is a multi-centre, individually randomised trial with clustering in the intervention arm. The researchers will aim to recruit 1337 older people with frailty from general practices across five localities in England over a period of 15 months. Potential participants will be identified by practice staff from primary care records according to pre-defined inclusion and exclusion criteria using bespoke electronic searches. Practice staff will send a letter of invitation for trial participation along with a participant information sheet to all eligible participants identified through the search. Participants will be requested to indicate their willingness to be involved in the study via a reply form returned via post to the research teams or via telephone. The local research team will visit willing participants at their own home to seek written informed consent and collection of baseline data.

Following consent and baseline data collection, an automated system will be used to randomly allocated to participants to either the usual care or PROSPER intervention. The PROSPER intervention is a 12-week tailored intervention delivered within a participant’s home by a trained Age UK delivery team around an individual’s personal priorities and predicaments within a socially-orientated model of care. Age UK workers will deliver the intervention to several participants and therefore the study has a partially nested hierarchical design resulting in clustering within the intervention arm.

As part of the study, the researchers will define usual care as “the wide range of care that is provided in a community whether it is adequate or not, without a normative judgement”, and will be available to all study participants including those in the intervention arm. To increase external validity and relevance of the study findings the researchers plan to use an unrestricted usual care approach, whereby the protocol does not restrict access to usual care. Use of services will be recorded at baseline and at follow-up assessments in both intervention and control arms.

To help further understand the implementation of the intervention and usual care, researchers will also be observing the delivery of the intervention, and performing interviews with staff, participants, and their carers in a sample of willing participants. This is called an embedded process evaluation.

Follow-up data will be collected from all participants at 6 and 12 months following randomisation. This data will be self-reported, with participants either completing postal questionnaires, telephone assessments, or completing questionnaires with researcher support, dependent upon the participant’s abilities. Researchers will also collect additional data regarding the participant’s safety (e.g. hospital admissions), and health and social care resource use (i.e. primary/secondary care) from the participant's electronic health records. Researchers collecting follow-up data will be unaware of the participant's allocation (blind) and will be asked to document if they become aware of the participant's allocation during the study.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Health-related quality of life measured using the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Short-Form 12 item Health Questionnaire (SF12) at 12 months post-randomisation

Secondary outcome measures

1. Basic and instrumental activities of daily living, measured using the Nottingham Extended Activities of Daily Living Scale (NEADL) at 12 months post-randomisation
2. Admissions to care homes and overall health and social care resource use, measured by participant-reported and routine data derived resource use at 12 months post-randomisation
3. Cost-effectiveness measured using decision analytical cost-effectiveness model at 12 months post-randomisation
4. Generalisability of PCP across the wider NHS measured using a mixed-methods process evaluation at 3 months post-randomisation:
4.1. Assessment of intervention fidelity by examining training & skill acquisition, intervention delivery, content of care sessions, receipt and enactment using observations, qualitative interviews and quantitative data
4.2. Process of implementation within the service context explored using a combination of qualitative observations, semi-structured interviews and documentary analysis

Overall trial start date

01/09/2019

Overall trial end date

30/03/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. eFI score of 0.21 or above
2. Aged 65 years or over
3. Willing and able to give informed consent (or personal consultee if lack capacity)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 1,337; UK Sample Size: 1,337

Participant exclusion criteria

1. Care home resident at the time of screening
2. Registered on the gold standards framework
3. Severe cognitive impairment (Montreal Cognitive Assessment score <10)

Recruitment start date

01/01/2021

Recruitment end date

30/03/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NIHR CRN: Yorkshire and Humber
S10 2SB
United Kingdom

Trial participating centre

NIHR CRN: Greater Manchester
M13 9WL
United Kingdom

Trial participating centre

NIHR CRN: North West Coast
L7 8XP
United Kingdom

Sponsor information

Organisation

Bradford Teaching Hospitals NHS Foundation Trust

Sponsor details

c/o Jane Dennison
Research Management & Support Office
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 382575
Jane.Dennison@bthft.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.bradfordhospitals.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0216-20003

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Protocol will be available
2. Planned publication and a high-impact peer-reviewed journal
3. The researchers also plan to disseminate results via Age UK website, institutional websites and in newsletters to stakeholders and PPI groups

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/03/2024

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/08/2020: Trial's existence confirmed by the NIHR.