Promoting independence in dementia (PRIDE): a feasibility randomised controlled trial of the PRIDE intervention for people with mild dementia

Not Applicable

Completed

• Conditions: Dementia; Mental and Behavioural Disorders; Unspecified dementia

• Registration Number: ISRCTN11288961
• Lead Sponsor: niversity of Nottingham

Brief Summary

2019 protocol in https://www.ncbi.nlm.nih.gov/pubmed/31829232 (added 13/12/2019) 2021 results in https://pubmed.ncbi.nlm.nih.gov/33664568/ (added 08/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-23
• Study Completion: 2020-06-30
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Inclusion criteria for the person with dementia:
To be eligible for the trial participants must meet all of the following inclusion criteria:
1. ­Resident within the catchment area of one of the participating NHS sites
2. ­Aged 18 or over; there is no upper age limit
3. ­Meet the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for dementia of any type, including Alzheimer’s, vascular, Lewy body type and mixed
4. ­Able to engage with and participate in the intervention in the judgement of the investigator or designee
5. ­Able to provide informed consent in the judgement of the investigator or designee
6. Able to read and communicate verbally in English
In addition, to be eligible for randomisation, the following inclusion criteria must be met. This is ascertained by a formal screening assessment completed after consent:
7. ­Mild dementia, defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale. The CDR will be completed during a face-to-face visit, as a post-consent screening assessment to determine eligibility for randomisation.

Inclusion criteria for the supportive other:
Note that participation of a supportive other is not mandatory and will be at the discretion of the participant. If the participant chooses to identify a supportive other they wish to participate with, the following inclusion criteria will apply:
1. Aged 18 or over; there is no upper age limit
2. ­Able to engage with and participate in the intervention
3. ­Able to provide informed consent
4. Able to read and communicate verbally in English

Exclusion Criteria

Exclusion criteria for the person with dementia:
­Living in institutional care

Study & Design

• Study Type: Interventional
• Study Design: Not specified