DementiaCOVIDWHELDNCT04590469
Improving Wellbeing and Health for Care Home Residents During COVID-19
A study testing COVID WHELD in people with Dementia, run by University of Exeter at 1 site in United Kingdom.
Trial summary
More than 400,000 people in the UK live in care homes. These individuals are particularly vulnerable to COVID-19; many are frail and the majority have concurrent physical health problems and dementia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- COVID WHELD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Care homes which include people with dementia within their client group
- All individuals residing in participating care homes who meet diagnostic criteria for dementia and/or score '1' or greater on the Clinical Dementia Rating Scale.
Who cannot join
- Care homes under special measures with the local authority
- Residents from whom consent or the advice of a consultee cannot be obtained.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evidence-Based Supported Digital Intervention for Improving Wellbeing and Health of People Living in Care Homes and Care Home Staff (WHELD) During COVID-19: An RCT to Evaluate COVID-19 Adapted E-WHELD: Benefits and Cost-Effectiveness
More than 400,000 people in the UK live in care homes. These individuals are particularly vulnerable to COVID-19; many are frail and the majority have concurrent physical health problems and dementia. This group are at the highest risk of becoming severely ill with COVID-19 and are dependent on a stretched care workforce. The isolation, together with the stresses and distressing nature of the current work environment is also likely to have an impact on the mental health and well-being of care staff. It is vital to provide good quality support to enable care staff to remain resilient, and to enable good quality care that maintains the well-being of residents with dementia and reduces emerging neuropsychiatric symptoms in residents without increasing harmful sedative medications.
COVID E-WHELD is based on the optimized WHELD training intervention on successfully completed in randomised clinical trials (RCTs) in 86 care homes, more than 1000 people with dementia. WHELD reduced use of anti-psychotics, improved agitation and overall neuropsychiatric symptoms, improved quality of life and reduced mortality for people with dementia. A digital version of WHELD (eWHELD) with virtual supervision in a further care home RCT including 130 people with dementia has demonstrated benefits for staff carers and improvements in the quality of life of people with dementia, with eWHELD combined with virtual supervision, but not with e-learning alone.
The current project will evaluate a COVID-19 adapted version of eWHELD to address current needs of care homes during the COVID-19 pandemic. This will be undertaken in a 2 arm, 4 month, randomized cluster RCT in 1280 care homes (allowing for 75% drop out with COVID-19 outbreaks) to determine whether COVID-19 adapted eWHELD improves quality of life and mental health for people with dementia in care homes and the mental health of care staff.
Read the detailed description
COVID E-WHELD: Effectiveness and Cost-Effectiveness
COVID-19 adapted WHELD (with digital resources and virtual coaching) will be compared to usual care in a 4 month randomized, parallel group, cluster RCT with 1280 care homes (allowing for 75% drop out because of COVID-19 outbreaks). Care homes will be randomly assigned to WHELD or treatment as usual in a 1:1 ratio. All care homes receiving treatment as usual will be offered the WHELD intervention after 4 months.
Recruitment will build upon a number of networks and contacts. The investigators already have a network of more than 1300 care homes who would be our first point of contact (100 additional care homes from Biomedical Research Centre (BRC) care home network. The investigators have a long established and successful record of recruiting large numbers of care homes to clinical trials (WHELD programme, FITS programme, Pimavanserin programme which involved more than 160 care homes).
Evaluation will be undertaken at baseline, 4 weeks and 4 months post-baseline.
The primary outcome measure will be quality of life in care home residents at 4 months, measured by the DEMQOL proxy, which has shown significant benefits in previous WHELD RCTs. The secondary outcomes will include cost-effectiveness (EQ-5D), health utilization, use of sedative medications (anti psychotics, hypnotics), neuropsychiatric symptoms, staff confidence (CODE), staff self-efficacy (SCIDS) and staff mental health (PHQ9) and a COVID-19 tracker.
Process measures collected by coaches will include Goal Attainment,
Assessments will be conducted by telephone or Microsoft Teams, by trained Research Assistants, or with the added option of being collected digitally for staff self-report measures.
Data will also be collected on numbers of remote health and social care (HSC) consultations and on unplanned hospital attendances/admissions (including fall-related injuries). Researchers will also fully cost the COVID eWHELD intervention. To examine the opportunity costs of the intervention, champions will be asked to identify activities that were not undertaken in order to participate and to report any paid and unpaid overtime related to time spent in the champion role. Unit costs will be obtained from nationally applicable sources (PSSRU UC, NHS Reference costs) or calculated anew where necessary.
Key elements of the WHELD intervention include:
- Coaching/training to deliver the WHELD programme which includes person-centred care and person-centred activities and person-centred care plans.
- A COVID-19 specific resource toolkit - digital bite-sized practical content to stay connected, develop new routines, how to respond to virus-related fear and anxiety
- Facilitated online peer support network for care home managers to share stories and solutions for COVID-19 challenges
- Pooling insights from others to create short, digestible digital resources, such as: checklists, video tips, one-page guides, do's and don'ts, infographics, etc.
- Providing communal, collaborative online group supervision calls, to promote staff well-being and peer-to-peer communities in an online gathering place
- Developing easy reference guides to enable staff to support residents, where appropriate, to use virtual communication tools to stay connected with family and friends
- Providing a series of suggestions, activities, and games all designed to foster connection during a time of isolation
As the intervention is optimized best practice, the researchers would consider this activity as service delivery and not research. The research element is the evaluation of potential benefits for residents and staff, and the evaluation of cost-effectiveness.
Analyses and reporting will follow CONSORT guidance. A full statical analysis plan will be developed during the initial phases of the project and signed off prior to database lock.
The UK Clinical Research Collaboration (UKCRC)-registered Exeter Clinical Trials Unit will be fully involved in the design, management and governance of the RCT aspects of the trial. The unit will have input into the methodology, provide central trial management/senior oversight, build and test the required data collection systems, undertake randomization, manage the data and ensure a surrounding quality assurance framework.
Care homes will specifically be able to pause participation in the study if there is a COVID-19 outbreak in the care home.
- Conditions
- Dementia
- Being tested
- COVID WHELD
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID WHELDOther
COVID WHELD is a COVID-19 adapted version of an established nursing home training intervention that confers benefits in well-being and neuropsychiatric symptoms for people with dementia. The adaptations include the development of digital resources to support the programme and virtual coaching.
| Study group | Role | What they receive |
|---|---|---|
| WHELD training/virtual coaching programme supported with digital resources | Experimental | WHELD training/virtual coaching programme supported with digital resources Receives: Other: COVID WHELD |
| Treatment as Usual | No intervention | Usual Best practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dementia Quality of Life - DEMQOL proxy
Validated quality of life measure for people with dementia, assessed by informant interview. Minimum score = 32 Maximum score = 128; Higher score denotes better outcome.
Measured: 4 months
Secondary outcomes (7)
Neuropsychiatric Inventory
Standardized assessment of neuropsychiatric symptoms in people with dementia, assessed by informant interview. Minimum score = 0 Maximum score = 144; Higher score denotes worse outcome.
Measured: 4 months
Psychotropic medications
Use of antipsychotic and other psychotropic medications from prescribing charts
Measured: 4 months
Confidence in Dementia (CODE) Scale
Staff confidence measure, self completed questionnaire. Minimum score = 9 Maximum score = 45; Higher score denotes better outcome.
Measured: 4 months
Sense of Competence in Dementia Care Staff (SCIDS) scale
Perceived self efficacy of care staff, self completed questionnaire. Minimum score = 17 Maximum score = 68; Higher score denotes better outcome.
Measured: 4 months
Patient Health Questionnaire (PHQ-9)
Mental Health of care staff, self reported questionnaire. Minimum score = 0 Maximum score = 27; Higher score denotes worse outcome.
Measured: 4 months
EQ5D (Euroquol 5D - 5 dimensions)
A standardized instrument for measuring generic health related quality of life, used for Health economic evaluation. Visual Analogue scale minimum score = 0, maximum score = 100. Higher score denotes better outcome.
Measured: 4 months
Client Service Receipt Inventory
to collect service utilization data for health economics. Assesses cost of service provision; as such no min/max values. Higher value denotes worse cost outcome.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Mar 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Why it stopped: no longer registered
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 month, randomized, parallel group cluster RCT comparing the WHELD nursing home programme with virtual coaching and digital support with treatment as usual
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, London School of Economics and Political Science, University of East Anglia, University of Hull, Alzheimer's Society
- Responsible party
- Sponsor
- Investigators
- Clive Ballard, MD, Principal investigator, The University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590469
- Sponsor's protocol ID
- 20-21-10
- Acronym
- COVIDWHELD
- Status last verified
- May 2024
- First submitted
- 13 Oct 2020
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ballard C, Corbett A, Orrell M, Williams G, Moniz-Cook E, Romeo R, Woods B, Garrod L, Testad I, Woodward-Carlton B, Wenborn J, Knapp M, Fossey J. Impact of person-centred care training and person-centred activities on quality of life, agitation, and antipsychotic use in people with dementia living in nursing homes: A cluster-randomised controlled trial. PLoS Med. 2018 Feb 6;15(2):e1002500. doi: 10.1371/journal.pmed.1002500. eCollection 2018 Feb.
PubMed 29408901Fossey J, Ballard C, Juszczak E, James I, Alder N, Jacoby R, Howard R. Effect of enhanced psychosocial care on antipsychotic use in nursing home residents with severe dementia: cluster randomised trial. BMJ. 2006 Apr 1;332(7544):756-61. doi: 10.1136/bmj.38782.575868.7C. Epub 2006 Mar 16.
PubMed 16543297Brooker DJ, Latham I, Evans SC, Jacobson N, Perry W, Bray J, Ballard C, Fossey J, Pickett J. FITS into practice: translating research into practice in reducing the use of anti-psychotic medication for people with dementia living in care homes. Aging Ment Health. 2016 Jul;20(7):709-18. doi: 10.1080/13607863.2015.1063102. Epub 2015 Jul 13.
PubMed 26167720Ballard C, Banister C, Khan Z, Cummings J, Demos G, Coate B, Youakim JM, Owen R, Stankovic S; ADP Investigators. Evaluation of the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer's disease psychosis: a phase 2, randomised, placebo-controlled, double-blind study. Lancet Neurol. 2018 Mar;17(3):213-222. doi: 10.1016/S1474-4422(18)30039-5.
PubMed 29452684Smith SC, Lamping DL, Banerjee S, Harwood RH, Foley B, Smith P, Cook JC, Murray J, Prince M, Levin E, Mann A, Knapp M. Development of a new measure of health-related quality of life for people with dementia: DEMQOL. Psychol Med. 2007 May;37(5):737-46. doi: 10.1017/S0033291706009469. Epub 2006 Dec 19.
PubMed 17176501EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PubMed 10109801Elvish R, Burrow S, Cawley R, Harney K, Pilling M, Gregory J, Keady J. 'Getting to Know Me': The second phase roll-out of a staff training programme for supporting people with dementia in general hospitals. Dementia (London). 2018 Jan;17(1):96-109. doi: 10.1177/1471301216634926. Epub 2016 Feb 27.
PubMed 26924840Schepers AK, Orrell M, Shanahan N, Spector A. Sense of competence in dementia care staff (SCIDS) scale: development, reliability, and validity. Int Psychogeriatr. 2012 Jul;24(7):1153-62. doi: 10.1017/S104161021100247X. Epub 2012 Feb 20.
PubMed 22340666Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Gordon JE, Powell C, Rockwood K. Goal attainment scaling as a measure of clinically important change in nursing-home patients. Age Ageing. 1999 May;28(3):275-81. doi: 10.1093/ageing/28.3.275.
PubMed 10475864Ballard C, Orrell M, YongZhong S, Moniz-Cook E, Stafford J, Whittaker R, Woods B, Corbett A, Garrod L, Khan Z, Woodward-Carlton B, Wenborn J, Fossey J. Impact of Antipsychotic Review and Nonpharmacological Intervention on Antipsychotic Use, Neuropsychiatric Symptoms, and Mortality in People With Dementia Living in Nursing Homes: A Factorial Cluster-Randomized Controlled Trial by the Well-Being and Health for People With Dementia (WHELD) Program. Am J Psychiatry. 2016 Mar 1;173(3):252-62. doi: 10.1176/appi.ajp.2015.15010130. Epub 2015 Nov 20.
PubMed 26585409
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-Based Supported Digital Intervention for Improving Wellbeing and Health of People Living in Care Homes and Care Home Staff (WHELD) During COVID-19: An RCT to Evaluate COVID-19 Adapted E-WHELD: Benefits and Cost-Effectiveness
- ClinicalTrials.gov ID
- NCT04590469
- Acronym / sponsor ID
- COVIDWHELD / 20-21-10
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no longer registered
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- King's College London, London School of Economics and Political Science, University of East Anglia, University of Hull, Alzheimer's Society
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than 400,000 people in the UK live in care homes. These individuals are particularly vulnerable to COVID-19; many are frail and the majority have concurrent physical health problems and dementia. This group are at the highest risk of becoming severely ill with COVID-19 and are dependent on a stretched care workforce. The isolation, together with the stresses and distressing nature of the current work environment is also likely to have an impact on the mental health and well-being of care staff. It is vital to provide good quality support to enable care staff to remain resilient, and to enable good quality care that maintains the well-being of residents with dementia and reduces emerging neuropsychiatric symptoms in residents without increasing harmful sedative medications.
COVID E-WHELD is based on the optimized WHELD training intervention on successfully completed in randomised clinical trials (RCTs) in 86 care homes, more than 1000 people with dementia. WHELD reduced use of anti-psychotics, improved agitation and overall neuropsychiatric symptoms, improved quality of life and reduced mortality for people with dementia. A digital version of WHELD (eWHELD) with virtual supervision in a further care home RCT including 130 people with dementia has demonstrated benefits for staff carers and improvements in the quality of life of people with dementia, with eWHELD combined with virtual supervision, but not with e-learning alone.
The current project will evaluate a COVID-19 adapted version of eWHELD to address current needs of care homes during the COVID-19 pandemic. This will be undertaken in a 2 arm, 4 month, randomized cluster RCT in 1280 care homes (allowing for 75% drop out with COVID-19 outbreaks) to determine whether COVID-19 adapted eWHELD improves quality of life and mental health for people with dementia in care homes and the mental health of care staff.
Detailed description
COVID E-WHELD: Effectiveness and Cost-Effectiveness
COVID-19 adapted WHELD (with digital resources and virtual coaching) will be compared to usual care in a 4 month randomized, parallel group, cluster RCT with 1280 care homes (allowing for 75% drop out because of COVID-19 outbreaks). Care homes will be randomly assigned to WHELD or treatment as usual in a 1:1 ratio. All care homes receiving treatment as usual will be offered the WHELD intervention after 4 months.
Recruitment will build upon a number of networks and contacts. The investigators already have a network of more than 1300 care homes who would be our first point of contact (100 additional care homes from Biomedical Research Centre (BRC) care home network. The investigators have a long established and successful record of recruiting large numbers of care homes to clinical trials (WHELD programme, FITS programme, Pimavanserin programme which involved more than 160 care homes).
Evaluation will be undertaken at baseline, 4 weeks and 4 months post-baseline.
The primary outcome measure will be quality of life in care home residents at 4 months, measured by the DEMQOL proxy, which has shown significant benefits in previous WHELD RCTs. The secondary outcomes will include cost-effectiveness (EQ-5D), health utilization, use of sedative medications (anti psychotics, hypnotics), neuropsychiatric symptoms, staff confidence (CODE), staff self-efficacy (SCIDS) and staff mental health (PHQ9) and a COVID-19 tracker.
Process measures collected by coaches will include Goal Attainment,
Assessments will be conducted by telephone or Microsoft Teams, by trained Research Assistants, or with the added option of being collected digitally for staff self-report measures.
Data will also be collected on numbers of remote health and social care (HSC) consultations and on unplanned hospital attendances/admissions (including fall-related injuries). Researchers will also fully cost the COVID eWHELD intervention. To examine the opportunity costs of the intervention, champions will be asked to identify activities that were not undertaken in order to participate and to report any paid and unpaid overtime related to time spent in the champion role. Unit costs will be obtained from nationally applicable sources (PSSRU UC, NHS Reference costs) or calculated anew where necessary.
Key elements of the WHELD intervention include:
- Coaching/training to deliver the WHELD programme which includes person-centred care and person-centred activities and person-centred care plans.
- A COVID-19 specific resource toolkit - digital bite-sized practical content to stay connected, develop new routines, how to respond to virus-related fear and anxiety
- Facilitated online peer support network for care home managers to share stories and solutions for COVID-19 challenges
- Pooling insights from others to create short, digestible digital resources, such as: checklists, video tips, one-page guides, do's and don'ts, infographics, etc.
- Providing communal, collaborative online group supervision calls, to promote staff well-being and peer-to-peer communities in an online gathering place
- Developing easy reference guides to enable staff to support residents, where appropriate, to use virtual communication tools to stay connected with family and friends
- Providing a series of suggestions, activities, and games all designed to foster connection during a time of isolation
As the intervention is optimized best practice, the researchers would consider this activity as service delivery and not research. The research element is the evaluation of potential benefits for residents and staff, and the evaluation of cost-effectiveness.
Analyses and reporting will follow CONSORT guidance. A full statical analysis plan will be developed during the initial phases of the project and signed off prior to database lock.
The UK Clinical Research Collaboration (UKCRC)-registered Exeter Clinical Trials Unit will be fully involved in the design, management and governance of the RCT aspects of the trial. The unit will have input into the methodology, provide central trial management/senior oversight, build and test the required data collection systems, undertake randomization, manage the data and ensure a surrounding quality assurance framework.
Care homes will specifically be able to pause participation in the study if there is a COVID-19 outbreak in the care home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 4 month, randomized, parallel group cluster RCT comparing the WHELD nursing home programme with virtual coaching and digital support with treatment as usual
| Arm | Type | Receives |
|---|---|---|
| WHELD training/virtual coaching programme supported with digital resources | Experimental | Other: COVID WHELDWHELD training/virtual coaching programme supported with digital resources |
| Treatment as Usual | No intervention | –Usual Best practice |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Care homes which include people with dementia within their client group
- All individuals residing in participating care homes who meet diagnostic criteria for dementia and/or score '1' or greater on the Clinical Dementia Rating Scale.
Key exclusion criteria (2 listed)
- Care homes under special measures with the local authority
- Residents from whom consent or the advice of a consultee cannot be obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID WHELDCOVID WHELD is a COVID-19 adapted version of an established nursing home training intervention that confers benefits in well-being and neuropsychiatric symptoms for people with dementia. The adaptations include the development of digital resources to support the programme and virtual coaching. | Other | WHELD training/virtual coaching programme supported with digital resources |
Primary outcome
Dementia Quality of Life - DEMQOL proxy
Time frame: 4 months
Validated quality of life measure for people with dementia, assessed by informant interview. Minimum score = 32 Maximum score = 128; Higher score denotes better outcome.
7 secondary outcomes
Neuropsychiatric Inventory
Time frame: 4 months
Psychotropic medications
Time frame: 4 months
Confidence in Dementia (CODE) Scale
Time frame: 4 months
Sense of Competence in Dementia Care Staff (SCIDS) scale
Time frame: 4 months
Patient Health Questionnaire (PHQ-9)
Time frame: 4 months
EQ5D (Euroquol 5D - 5 dimensions)
Time frame: 4 months
Client Service Receipt Inventory
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 29408901Ballard C, Corbett A, Orrell M, Williams G, Moniz-Cook E, Romeo R, Woods B, Garrod L, Testad I, Woodward-Carlton B, Wenborn J, Knapp M, Fossey J. Impact of person-centred care training and person-centred activities on quality of life, agitation, and antipsychotic use in people with dementia living in nursing homes: A cluster-randomised controlled trial. PLoS Med. 2018 Feb 6;15(2):e1002500. doi: 10.1371/journal.pmed.1002500. eCollection 2018 Feb.
- Background: PubMed 16543297Fossey J, Ballard C, Juszczak E, James I, Alder N, Jacoby R, Howard R. Effect of enhanced psychosocial care on antipsychotic use in nursing home residents with severe dementia: cluster randomised trial. BMJ. 2006 Apr 1;332(7544):756-61. doi: 10.1136/bmj.38782.575868.7C. Epub 2006 Mar 16.
- Background: PubMed 26167720Brooker DJ, Latham I, Evans SC, Jacobson N, Perry W, Bray J, Ballard C, Fossey J, Pickett J. FITS into practice: translating research into practice in reducing the use of anti-psychotic medication for people with dementia living in care homes. Aging Ment Health. 2016 Jul;20(7):709-18. doi: 10.1080/13607863.2015.1063102. Epub 2015 Jul 13.
- Background: PubMed 29452684Ballard C, Banister C, Khan Z, Cummings J, Demos G, Coate B, Youakim JM, Owen R, Stankovic S; ADP Investigators. Evaluation of the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer's disease psychosis: a phase 2, randomised, placebo-controlled, double-blind study. Lancet Neurol. 2018 Mar;17(3):213-222. doi: 10.1016/S1474-4422(18)30039-5.
- Background: PubMed 17176501Smith SC, Lamping DL, Banerjee S, Harwood RH, Foley B, Smith P, Cook JC, Murray J, Prince M, Levin E, Mann A, Knapp M. Development of a new measure of health-related quality of life for people with dementia: DEMQOL. Psychol Med. 2007 May;37(5):737-46. doi: 10.1017/S0033291706009469. Epub 2006 Dec 19.
- Background: PubMed 10109801EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
- Background: PubMed 26924840Elvish R, Burrow S, Cawley R, Harney K, Pilling M, Gregory J, Keady J. 'Getting to Know Me': The second phase roll-out of a staff training programme for supporting people with dementia in general hospitals. Dementia (London). 2018 Jan;17(1):96-109. doi: 10.1177/1471301216634926. Epub 2016 Feb 27.
- Background: PubMed 22340666Schepers AK, Orrell M, Shanahan N, Spector A. Sense of competence in dementia care staff (SCIDS) scale: development, reliability, and validity. Int Psychogeriatr. 2012 Jul;24(7):1153-62. doi: 10.1017/S104161021100247X. Epub 2012 Feb 20.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 10475864Gordon JE, Powell C, Rockwood K. Goal attainment scaling as a measure of clinically important change in nursing-home patients. Age Ageing. 1999 May;28(3):275-81. doi: 10.1093/ageing/28.3.275.
- Results publication: PubMed 26585409Ballard C, Orrell M, YongZhong S, Moniz-Cook E, Stafford J, Whittaker R, Woods B, Corbett A, Garrod L, Khan Z, Woodward-Carlton B, Wenborn J, Fossey J. Impact of Antipsychotic Review and Nonpharmacological Intervention on Antipsychotic Use, Neuropsychiatric Symptoms, and Mortality in People With Dementia Living in Nursing Homes: A Factorial Cluster-Randomized Controlled Trial by the Well-Being and Health for People With Dementia (WHELD) Program. Am J Psychiatry. 2016 Mar 1;173(3):252-62. doi: 10.1176/appi.ajp.2015.15010130. Epub 2015 Nov 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clive Ballard, MD principal investigator
The University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID WHELD in people with Dementia, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dementia Quality of Life - DEMQOL proxy (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04590469, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.