Testing a new psychological intervention to support independence at home for people with dementia and their family or friends (NIDUS-Family study)

Not Applicable

• Conditions: Dementia; Mental and Behavioural Disorders

• Registration Number: ISRCTN11425138
• Lead Sponsor: niversity College London

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34857029/ (added 09/05/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35680268/ Protocol of embedded process evaluation (added 10/06/2022) 2024 Results article in https://doi.org/10.1016/S2666-7568(23)00262-3 (added 02/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-07
• Last Update Posted: 12 February 2024
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 604

Inclusion Criteria

People with dementia:
1. People with a documented diagnosis of dementia of any severity who are living in their own homes (including sheltered accommodation, where staff are not on site 24 hours a day) alone or with others
2. people with dementia who have a family carer willing to participate in the study

Family carers:
3. In regular (at least weekly face-to-face or telephone contact) with the person with dementia
4. Can speak English sufficiently well to participate in the intervention

Exclusion Criteria

1. People living with dementia who are receiving palliative care support and considered to be in the last 6 months of their life.
2. Family carers who lack capacity to consent
3. Currently enrolled in another intervention trial/research study
4. Unable to identify three or more goals

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functioning of the person with dementia assessed using family carer-rated Goal Attainment Scaling (GAS) at 12 months. The GAS questionnaire is valid, reliable and responsive to change in function in people with dementia living at home up to 12 months. Trained researchers will work with family carers and people with dementia to set SMART (Specific, Measurable, Achievable, Realistic and Timely) goals across domains of: cognition, instrumental activities of daily life/self-care, mood, behaviour and mobility. Family carers will evaluate ‘performance’ on a minimum of three and maximum of five goals set at baseline, on a 5-point scale ranging from 'much worse' to 'much better' than expected.