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Improving Well-being and HEaLth for people with Dementia

An optimized person-centred intervention to improve quality of life for people with dementia living in care homes: a cluster randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN62237498
Enrollment
1280
Registered
2013-10-04
Start date
2013-09-15
Completion date
Unknown
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia Mental and Behavioural Disorders Unspecified dementia

Interventions

Care homes are randomised to two arms: Intervention and control arms Homes in the intervention arm will receive the WHELD intervention training for 9 months. The homes within the contr

Sponsors

King's College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Care homes who identify themselves as catering for people with dementia within its literature 2. Care homes should be able to demonstrate a minimum acceptable standard of care according to Care Quality Commision (CQC) 3. All individuals residing in participating care homes who meet diagnostic criteria and/or scores 1 or greater, on the Clinical Dementia Rating Scale (CDR) Target Gender: Male & Female; Upper Age Limit 110 years ; Lower Age Limit 35 years

Exclusion criteria

Exclusion criteria: 1. Less than 60% of the residents have dementia 2. Care home is receiving special support from their local authority 3. Care home has failed to meet the 5 CQC care home quality standards checks with no more than one black mark (at least one standard in this area was not being met and required improvements are required) and no red marks (at least one standard in this area was not being met and enforcement have been taken): 3.1. Standards of treating people with respect and involving them in their care 3.2. Standards of providing care, treatment & support which meets people's needs 3.3. Standards of caring for people safely & protecting them from harm 3.4. Standards of staffing 3.5. Standards of management 4. Care home unable to provide care staff champions or staff able to act as informants for participant assessments 5. Events or major changes anticipated to take place in the next 12 months, which might impact on involvement in the research 6. Care home involved in other research projects, which might affect their suitability to take part in this study or place too much burden on staff and residents 7. Undergoing systematic programme of service improvement: Involved in a systematic programme of service improvement (e.g. intensive Dementia Care Mapping) 8. Any resident for whom consent is not obtained

Design outcomes

Primary

MeasureTime frame
Quality of Life as measured by DEMQOL proxy. DEMQOL-Proxy is a 31 item interviewer-administered questionnaire answered by a caregiver with the score range of 31 to 124.

Secondary

MeasureTime frame
1. Quality of Life measured by DEMQOL rated with person with dementia, which is a 28 item interviewer-administered questionnaire with the score range of 28 to 112 and Quality of life in late ? stage dementia (QUALID), which measures 11 observable behaviours indicating activity and emotional states. Ratings are made for observations made over the preceding 7 days 2. Agitation and other behavioural and neuropsychiatric symptoms are measured by Cohen-Mansfield Agitation Inventory (CMAI) and Neuropsychiatric Inventory nursing home version, NPI-NH). The CMAI consists of 29 items related to agitated behaviour, each of which is rated on a 7-point scale of frequency, from 1 = never to 7 = several times an hour. NPI-NH is a 12-item version consisting of 10 behavioural and two neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. 3. Antipsychotic use and other psychotropic (sedative) drugs (number of people taking antipsychotics and dose, rated from drug charts) 4. Unmet needs are assessed by Camberwell Assessment of Need for the Elderly (CANE Version IV). CANE is a comprehensive assessment assessing 24 areas of social, medical, psychological, and environmental needs 5. Symptoms of mood and depression are measured by (Cornell Scale for Depression in Dementia - CSDD). Each item in CSDD is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe) 6. Pain is rated using the Abbey Pain Scale, which is an observational brief indicator of pain for people with end-stage dementia. The scale is rated on six non verbal indicators of pain where 0 is none and 3 is severe. 7. The quality of interactions between staff and residents and person centred environment in care home settings are rated using the observational tool Quality of Interaction Scale (QUIS) 8. Economic health evaluation will be performed by usi

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026