Testing a support package on wellbeing of carers of people with dementia: a randomised controlled trial

Not Applicable

Recruiting

• Conditions: Dementia; Public Health - Health service research; Neurological - Dementias; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12621000474853
• Lead Sponsor: The University of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-21
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Eligible carers will be caring for a person with a confirmed diagnosis of dementia who has seen a geriatrician within the past 12 months, and who is aged 18 years or over, proficient in the English language and able to give informed consent. A carer is defined as an individual (e.g. relative, friend, neighbour) who takes responsibility for assisting a person with dementia. They may live with, or separately from, the person with dementia.

Exclusion Criteria

Carers of people with dementia who are living in nursing homes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms of depression in carers of people with dementia using a multi-component resource package compared to carers accessing usual (current) care. This will be assessed by the 20-item Centre for Epidemiologic Studies Depression Scale (CES-D).[Symptoms of depression will be assessed at baseline, 3 months and 6 months (primary endpoint).];Burden in carers of people with dementia using a multi-component resource package compared to carers accessing usual (current) care. This will be assessed using the 12-item Zarit Burden Interview (ZBI), which measures subjective burden associated with functional/behavioural impairments and the home care situation.[Burden will be assessed at baseline, 3 months and 6 months (primary endpoint).]

Secondary Outcome Measures

Name	Time	Method
Symptoms of dementia causing concern to carers in intervention arm compared to carers accessing usual (current) care. This will be assessed using a multi-component checklist derived from validated measures of dementia symptoms (e.g. Neuropsychiatric Inventory Questionnaire) and the literature, including carer guidelines for managing behavioural-psychological symptoms of dementia. The checklist reflects both level of concern and frequency of concerning symptoms. <br><br>[Symptoms of dementia causing concern will be assessed at baseline, 3 months and 6 months.]