Specialty: Dementias and neurodegeneration, Primary sub-specialty: Dementia
Conditions
Interventions
Services are randomised to receive either the management toolkit (interventional sites) or to continue their usual management of the patients (control sites). The management toolkit is a recommended g
Sponsors
Northumberland, Tyne and Wear NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A clinician diagnosis of LBD has been documented as the result of specialist service assessment (possible or probable diagnosis) 2. Consent can be obtained from the patient or, for those subjects lacking capacity, from a consultee In addition to the above criteria: WP5A: Patients aged 60 and over with at least 1 active clinical issue as determined by the treating clinical team. WP5B: Patients aged 60 and over with a diagnosis of Parkinson’s disease where a memory problem has developed.
Exclusion criteria
Exclusion criteria: 1. Patients who have explicitly expressed a wish not to be approached to take part in research 2. Patients who have been approached to take part in this study previously (as part of another participating service) 3. Patients who have a severe or terminal illness and reduced life expectancy which compromises their ability to comply with the protocol 4. Insufficient English to allow completion of the study measures 5. Patients who are assessed as not able to complete the outcome measures for the study. Clinicians may choose not to use the management tool at some assessments if they feel it is not appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility of use of the intervention is assessed by Clinician Toolkit Feedback Questionnaire at approximately 6 months after service has been randomised and at the end of the trial. 2. Impact of the assessment and management toolkit on patient management, health outcomes, and its impact on informants/carers is assessed by this is assessed through collection of outcome measured at baseline, 3 and 6 months 3. Cost-effectiveness of the new assessment and management toolkit for LBD with usual care is assessed by this is assessed by the Use of services and costs Questionnaire at Baseline, 3 months and 6 months and Time and Travel Questionnaire at 6 months as listed below | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptom severity is measured using the reduced Neuropsychiatric Inventory (NPI) score; lower unified Parkinson’s disease rating scale (UPDS) score; Dementia Cognitive Fluctuation Scale (DCFS-R), lower Cornell depression score, Galvin Lewy Body Composite Score and Geriatric Depression Scale at baseline, 3 and 6 months 2. Patient quality of life is measured using the patient EQ-5D-5L and carer proxy EQ-5D-5L; patient DEMQOL and carer DEMQOL-proxy scales at baseline, 3 and 6 months 3. Rates of cognitive decline is measured using the MMSE and MoCA scales at baseline, 3 and 6 months 4. Carer stress and quality of life is measured using the carer EQ-5D-5L; HADS; and Zarit burden scale at baseline, 3 and 6 months 5. Global outcome is measured using the Global outcome Scale at 3 months and 6months. 6. Heath economic measures are measured using the non-standardised questionnaires developed by the research team as follows: Time and Travel Questionnaire at 6 months and Use of services and costs Questionnaire at Baseline, 3 months and 6 months | — |
Countries
England, United Kingdom
Contacts
Public ContactSarah Dunn
Outcome results
None listed