Impact on patient anxiety and quality of life of a training package for evaluation of dementia symptoms in primary care using test bundles - the Ensemble feasibility study
| ISRCTN | ISRCTN72604284 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72604284 |
| Integrated Research Application System (IRAS) | 342515 |
| Central Portfolio Management System (CPMS) | 61841 |
| Sponsor | University of Bristol |
| Funder | Research for Patient Benefit Programme |
- Submission date
- 09/12/2025
- Registration date
- 28/01/2026
- Last edited
- 06/02/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Having symptoms of dementia, and waiting for a diagnosis, can be a very anxious time. The pressure on secondary care-based memory services is increasing. Timely diagnosis is essential for people affected by dementia to access to treatment, support, and care planning. Current diagnostic pathways are often slow and burdensome, with waiting times for memory clinics reaching up to two years.
Primary care offers a potential route to earlier diagnosis, but time and resources are constrained. This study explores whether a structured, scalable approach—using trained Health Care Assistants (HCAs) to administer cognitive test bundles—can support GPs in making timely and accurate diagnoses for patients aged 75 and over.
Who can participate?
People may participate if they are 75 or older, have had cognitive symptoms for more than 6 months but no prior diagnosis of dementia, and have a supporter/partner/carer who is prepared to complete information and supporter questionnaires.
People may not participate if they have another neurological condition that typically requires specialist assessment, a sensory impairment, a learning disability, or do not have a supporter/partner/carer/
What does the study involve?
The study involves delivery of training packages to enable General Practitioners (GPs) to identify appropriate patients and select tailored cognitive test bundles, which are then administered by Healthcare Assistants (HCAs) in NHS primary care settings. A bespoke training package will be also delivered to HCAs to support their care of patients with cognitive symptoms and the administration of the assessments. The bundles include a cognitive test, an informant questionnaire, and a functionality assessment. The results will help inform GP led diagnosis in primary care.
What are the possible benefits and risks of participating?
The structured and tailored assessments that participants would be given may support more timely and robust clinical decision making. Referral to unsettling and unfamiliar secondary care environments may be avoided, and diagnoses may be delivered in the more familiar and local primary care environment.
There are no known or anticipated risks from participation.
Where is the study run from?
The study is run from the Centre for Academic Primary Care, Bristol Medical School, University of Bristol (UK).
When is the study starting and how long is it expected to run for?
Recruitment will commence December 2025 and may continue until September 2026.
Who is funding the study?
National Institute for Health Research, Research for Patient Benefit (rfpb@nihr.ac.uk)
Who is the main contact?
Chief Investigator: Dr Sam Creavin MRCGP PhD, NIHR Clinical Lecturer General Practice, sam.creavin@bristol.ac.uk
Study coordinator: Leigh Johnson, leigh.johnson@bristol.ac.uk
Contact information
Public, Scientific, Principal investigator
Canynge Hall
Clifton
Bristol
BS8 2PN
United Kingdom
 ORCID ID |
0000-0002-6772-7111 |
|---|---|
| Phone | +44 (0)1174560397 |
| sam.creavin@bristol.ac.uk |
Public
Senior Research Associate
The Ensemble Dementia Study
Centre for Academic Primary Care
Population Health Sciences
Bristol Medical School
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
| leigh.johnson@bristol.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster feasibility trial (not randomized) |
| Secondary study design | Non randomised study |
| Scientific title | Impact on patient anxiety and quality of life of a training package for evaluation of dementia symptoms in primary care using test bundles - the Ensemble feasibility study |
| Study acronym | Ensemble |
| Study objectives | To hasten the diagnosis and treatment of some patients with cognitive symptoms, to reduce the anxious time for patients waiting for a diagnosis, and to reduce the burden on specialist services |
| Ethics approval(s) |
Approved 13/11/2025, Harrow REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8154; harrow.rec@hra.nhs.uk), ref: 25/LO/0760 |
| Health condition(s) or problem(s) studied | Dementia |
| Intervention | This study explores whether a structured, scalable approach, using trained Health Care Assistants (HCAs) to administer cognitive test bundles tailored to patient presentation, can support GPs in making timely and accurate diagnoses for patients aged 75 years and over. Potential participants may learn about the study via posters in the GP practice, via contact from the practice inviting them to review study information and speak to their GP if interested, or via a GP proactively mentioning the study and discussing the possibility of participation during a consultation. If the GP considers a patient to be potentially eligible, they will provide a brief information leaflet and ask for verbal consent to share the patient’s contact details with the study team. The study coordinator contacts patients by phone or email to explain the study in more detail and to determine eligibility. Patients are then sent a participant information sheet by email or post. They are given as much time as they need to consider participation, with no imposed deadline. Two approaches to consent will be tested – one is consent received by an Ensemble-trained Healthcare Assistant (HCA) at their GP practice, and one is consent received remotely by the Study Coordinator at the University of Bristol. If the patient agrees to participate, the study team will ask the GP practice to schedule an in-person Ensemble appointment. The participant is sent baseline General Anxiety Inventory (GAI), EQ5D and ICECAP-O questionnaires prior to attending their Ensemble appointment, where the HCA administers the cognitive test chosen by their GP as part of their tailored assessment bundle. During this appointment, the participant will be given the opportunity to undertake an optional 20-minute Cognospeak assessment. An appointment is then made for the participant to see the Ensemble-trained GP for a diagnostic consultation. The final involvement for the participant is completing follow-up GAI, EQ5D and ICECAP-O questionnaires 6 weeks after the Ensemble appointment. The total duration of the study activities, including the optional 20-minute Cognospeak assessment, is estimated to be 100 minutes. Supporter participation: Supporters (e.g. partners, carers or family members of the patient participants) are asked to complete questionnaires for Ensemble. It is not a requirement of the study that Supporters are present during the study activities of the patient participant, but Supporters will be asked to complete GAI, EQ5D, IQCODE, Lawton IADL and ASCOT questionnaires before the HCA-led Ensemble appointment, and the GAI and EQ5D 6 weeks later. We estimate that these questionnaires will take 20 minutes to complete. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Recruitment rate of eligible patients in each practice measured using recruitment records at the end of the study |
| Key secondary outcome measure(s) |
1. Acceptability of the intervention to patients, supporters, and healthcare professionals is measured using semi-structured interviews and observations at end of study |
| Completion date | 30/09/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 75 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Be aged 75 years or older 2. Present with cognitive symptoms for at least 6 months 3. Not have a prior diagnosis of dementia 4. Have a supporter they have known for several years who is prepared to complete informant and functionality questionnaires |
| Key exclusion criteria | 1. Sensory impairment (registered blind or unable to use a phone due to deafness) 2. Learning disability 3. No availability of a supporter (e.g. family member or friend) who knows them well and is willing to complete informant and functional questionnaires. Supporters may provide input remotely if needed 4. Presence of other neurological conditions (e.g. Parkinson’s disease) that would typically require specialist assessment |
| Date of first enrolment | 10/11/2025 |
| Date of final enrolment | 31/07/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Weston-super-mare
BS23 3HQ
England
Bristol
BS10 6SP
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The datasets generated and/or analysed during the study will be stored in a non-publicly available storage (encrypted University of Bristol servers): https://www.bristol.ac.uk/acrc/research-data-storage-facility/ |
Editorial Notes
06/02/2026: The following changes were made:
1. Ethics approval date added.
2. The study coordinator was added as a public contact.
09/12/2025: Study's existence confirmed by the HRA.
