Dementia Mental and Behavioural Disorders Dementia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants with dementia will meet the Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV) criteria for dementia. All types of dementia will be included, including Alzheimer's, vascular dementia, Dementia of Lewy Body type and mixed dementias. 2. Participants with dementia will be in the mild to moderate stage of dementia (Clinical Dementia Rating). 3. Participants with dementia will have some ability to communicate and understand communication: a score of 1 or 0 on the relevant items of the Clifton Assessment Procedures for the Elderly ? Behaviour Rating Scale. 4. Participants with dementia will be living in the community at the time of the baseline assessment, and will have a relative or other care-giver who maintains regular contact, can act as an informant, and would be willing and able to participate in the intervention with the person with dementia.
Exclusion criteria
Exclusion criteria: Participants will not have a major physical illness, sensory impairment, disability or a high level of agitation which could affect participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following will be assessed at baseline, 3 and 10 months after randomisation: 1. Quality of life for the person with dementia, self-assessed by the Quality of Life in Alzheimer's Disease (QoL-AD), which has been shown to be reliable and valid for people with mild and moderate degrees of dementia. The scale is completed in a structured interview with the person with dementia and covers 13 domains of life quality. 2. Care-giver's mental health, evaluated using the 28 item, self-report General Health Questionnaire GHQ-28 which has been widely used in care-giver research; the Likert scoring system 0-1-2-3 will be used. The scale includes indicators of anxiety, depression, insomnia, social dysfunction and somatic symptoms. This is preferred as the primary care-giver outcome to the Relatives' Stress Scale in this study, in view of its more general focus and wide usage. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed at baseline, 3 and 10 months after randomisation: 1. Autobiographical memory, assessed using an extended version of the Autobiographical Memory Interview (AMI). The extended AMI assesses recall of the person with dementia's personal memories relating to both factual (semantic) information for example, names of schools or teachers and specific incidents. In the trial platform, we validated an additional section on middle-age to retirement, to give systematic coverage to the life-span of our participants. 2. Measure of relationship quality, self-completed by both person with dementia and carer: Quality of the Care-giving Relationship (QCPR). Originally developed in the Netherlands this scale comprises 14 items (with 5 point Likert scales) designed to assess the warmth of the relationship and the absence of conflict and criticism. 3. Depression and anxiety for both people with dementia and carer: 3.1. Cornell Scale for Depression in Dementia (CSDD): A 19-item interviewer administered measure, using information from interview with the person with dementia and their carer. Signs and symptoms are described to the carer as they appear on the scale. Where there is a discrepancy between the carer and clinician's ratings the carer is re-interviewed before the interviewer makes the final judgment. 3.2. Rating for Anxiety In Dementia (RAID): An 18 item rating scale to measure anxiety in a person with dementia based on a structured interview with the carer and the person with dementia. 3.2. Hospital Anxiety and Depression Scale for carer: a 14-item, self-report well-validated scale, which provides an index of both anxiety and depression, and is suitable for use with adults of all ages. 4. Stress specific to the care-giving situation, assessed using the Relative's Stress Scale: self-report scale for the care-giver, contains 15 items rated on a 5-point Likert scale. 5. Quality of life of person with dementia, rated by the care-giver, assesse | — |
Countries
United Kingdom