Mental health, neurology and aging Mental and Behavioural Disorders Unspecified dementia
Conditions
Interventions
All participants will be assessed to identify areas where assistive technology and telecare can support participants and caregivers in the safe undertaking of occupational activities identified as imp
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical Dementia Rating of 1, 2 or 3 2. Fair access to care services (FACS) assessment indicates significant need 3. Working telephone line connected to home
Exclusion criteria
Exclusion criteria: 1. Patient already receiving an ATT intervention or has previously been provided with ATT but has failed to utilise it 2. Unstable medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There will be two co-primary outcome measures. 1. Time in days from randomisation to institutionalisation (defined as permanent transition from living in own home to nursing or residential care home) or to an admission to acute care facility that results in permanent placement in care home. 2. Cost-effectiveness of provision of assistive technology and telecare. Costs will be calculated by attaching nationally applicable unit cost measures to health and social service use and the costs of assistive technology and telecare provided collected with a modified version of the Client Service Receipt Inventory (CSRI) (Beecham and Knapp 2001) for each participant at baseline, 12, 24, 52 and 104 weeks. Data on both formal and informal caregiver inputs will be used to attach imputed values and EQ5D (EuroQoL Group 1990) and DEMQOL (Smith et al 2007) data will be used to calculate patient-specific QALYs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Burden in caregivers. We will measure both burden associated with care-giving and levels of psychological distress among the principal caregivers of participants at baseline, 12, 24, 52 and 104 weeks. The 12-item short version of the Zarit Burden Interview (ZBI) questions caregivers? experiences in terms of emotional, physical and social strains or difficulties that result from their role as a caregiver. Items include topics such as feeling one?s own health has suffered, feeling that care-giving has affected relationships with family and friends and how burdened one feels. Caregivers respond by indicating how often they experience each item and responses are scored on a 5-point scale ranging from never to frequently. Higher burden is indicated by a higher score and the combined 12 items have high reliability (alpha=.86) (Leggett et al 2010). We will assess psychological distress with the 12-item General Health Questionnaire (GHQ) to identify symptoms of common mental health difficulties such as anxiety and depression (Goldberg and Williams 1988). 2. Quality of life. We will measure health-related quality of life in patients at baseline, 24, 52 and 104 weeks using either DEMQOL; a 28-item interviewer-administered questionnaire that is self-reported by a person with dementia; or DEMQOL-Proxy; a 31-item questionnaire that is reported by a caregiver. DEMQOL has high levels of reliability and internal consistency in patients with mild to moderate dementia (alpha=.87) (Smith et al 2007). We will measure health-related quality of life in caregivers using the SF-12 (Jenkinson et al 1999). 3. Number and severity of serious adverse events. As in any trial, serious adverse events (requiring GP or hospital care) will be recorded and reported. We will develop a manual to describe, grade (in terms of severity or dangerousness) and record significant compromises of participant safety (e.g. fire setting, falls, episodes of getting | — |
Countries
United Kingdom
Outcome results
None listed