DIAMOND-Lewy: A pilot study of care provided by NHS services

Not Applicable

Completed

• Conditions: Specialty: Dementias and neurodegeneration, Primary sub-specialty: Dementia; UKCRC code/ Disease: Neurological/ Other degenerative diseases of the nervous system; Nervous System Diseases; Lewy Body Dementia (LBD)

• Registration Number: ISRCTN11083027
• Lead Sponsor: orthumberland, Tyne and Wear NHS Foundation Trust

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/32960456/ results (added 23/09/2020) 2021 Other publications in https://doi.org/10.1212/WNL.0000000000012450 Secondary analysis (added 13/02/2024) 2021 Results article in https://doi.org/10.3310/pgfar09070 (added 13/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-20
• Study Completion: 2019-02-01
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 131

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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<br>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