NCT01855152: WHELD

An Optimized Person Centred Intervention to Improve Quality of Life for People With Dementia Living in Care Homes. A Cluster Randomized Controlled Trial.

Status unknown NA Last updated 13 May 2013

What this trial tests

NA trial testing Optimised WHELD intervention in Dementia in 1,000 participants. Status unknown.

Timeline

1 August 2013

Primary endpoint
1 March 2015

1 March 2015

Quick facts

Lead sponsor	professor Clive Ballard
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	1,000
Start date	1 August 2013
Primary completion	1 March 2015
Estimated completion	1 March 2015
Sites	1 location across United Kingdom

Drugs / interventions tested

• Optimised WHELD intervention
• Treatment as usual

Conditions studied

• Dementia — all drugs for Dementia →

Sponsor

professor Clive Ballard

Who can join

Eligibility, any sex, with Dementia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Quality of Life (DEMQOL-proxy)
  Time frame: Change in quality of life from baseline assessment point to the 9 month intervention period in both intervention and control group
  DEMQOL-Proxy (main outcome measure) is a 31 item interviewer-administered questionnaire answered by a caregiver with the score range of 31 to 124. The The measure is also validated as a method for calculating Quality Adjusted life Year (QALY) for health economic analysis. DEMQOL (secondary outcome measure) assesses the health-related quality of life (HRQoL) for people with dementia. The measure c

Sponsor's own description

800,000 people in the United Kingdom (UK)have dementia, of which 250,000 are living in care homes. These individuals have complex mental health problems, disabilities and social needs, which if unmet will continue to adversely affect each individual, as well as the main goal of enabling people to "live well with dementia", as presented in the National Dementia Strategy (NDS) (Department of Health, 2009).

This optimized intervention WHELD is based on a factorial study and qualitative evaluation designed to facilitate the design of this current study and will combine this with the most effective elements of existing approaches to develop a comprehensive but practical intervention to improve quality of life in persons with dementia living in care homes. The intervention will combine training on person centred care, promoting person centred activities and interactions and provide care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes.

The overarching goal of this trial is to determine whether this optimised WHELD intervention is more effective in improving the quality of life and mental health, than the usual care provided people with dementia living in nursing homes. The cost effectiveness of the intervention will be assessed as well, with the aim to provide a cost effective, simple and practical intervention, improving quality of life and mental health of people with dementia in care homes; which can be rolled out nationally to all UK care homes as an National Health Service (NHS) intervention. The trial will be a randomised controlled 2-arm cluster single blind trial that will take place for 9 months across 80 care homes in UK.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of the Covid-19 pandemic on neuropsychiatric symptoms and antipsychotic prescribing for people with dementia in nursing home settings.
   McDermid J, Ballard C, Khan Z, Aarsland D, et al · · 2023 · cited 21× · PMID 36704984 · DOI 10.1002/gps.5878