DementiaCASCADENCT04258358
Evaluating the Community Areas of Sustainable Care and Dementia Excellence Model of Care
A study testing CASCADE ways of working in people with Dementia, run by Canterbury Christ Church University at 2 sites in United Kingdom.
Trial summary
The study evaluates the impact and cost effectiveness of community integrated dementia care. Some of the people living with dementia participating in the study will receive long term or respite care and support in the community tailored to CASCADE ways of working. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- CASCADE ways of working
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2022to Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Specific inclusion criteria for long-term residents:
- The person needs long-term rehabilitation or recovery for at least eight months.
- Specific inclusion criteria for guesthouse facilities
- The person needs emergency respite due to unforeseen circumstances
- In need of planned respite for example, due to informal carer's scheduled commitments
- The person needs short-term rehabilitation or recovery
- Using guesthouse with care facilities for a minimum of 14 days.
Who cannot join
- People with complex care needs that cannot be met at the project delivery sites during initial recruitment.
- People that will not consent to participate in the evaluation study.
- People living with dementia involved in other studies.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
East Kent Hospitals University National Health Service Foundation Trust
Canterbury, Kent, CT1 3NG
Medway Community Healthcare
Rochester, Kent
About this study
The study evaluates the impact and cost effectiveness of community integrated dementia care. Some of the people living with dementia participating in the study will receive long term or respite care and support in the community tailored to CASCADE ways of working. Other people living with dementia participating in the study will continue to use standard care as usual. The terms 'CASCADE model of care' and 'CASCADE ways of working' are used here interchangeably as appropriate.
Read the detailed description
The CASCADE ways of working draw on the person's strengths to optimize safety and independent living in their community. The ways of working incorporate learning and development for all stakeholders to enhance interactions with people living with dementia; use of technology to improve access to specialist care as well as safety in the community; and holistic care tailored to the needs of the person to improve and maintain well being. These elements work in tandem to enable people living with dementia to engage in meaningful leisure and activities of daily living.
The evaluation study aims to explore the benefits of the CASCADE model of care (ways of working) on service users (people with dementia and their caregivers), staff and service providers. The evaluation comprises elements of outcome and process evaluation. The outcome evaluation involves quantitative measures of health, well being and cost benefits while the process evaluation explores intervention implementation procedures to find out what worked and how it worked. The CASCADE model of care assumes that using the person's strengths to guide holistic personalized dementia care is a sustainable approach to safe meaningful independent living and improving public perceptions.
Investigators will use a quasi-experiment to assess quantifiable benefits (health and well being outcomes and cost benefits) of the CASCADE model for people with dementia. This means, investigators will compare two groups of people with dementia including one that will receive care under the CASCADE model (intervention group) and the second group will not. The anticipation is that comparing the two groups will make benefits of people receiving care under the CASCADE ways of working more observable. Participants will not be allocated randomly to the study arms because service use will be dependent on assessed need for referrals and need and affordability for self-referred users. This implies there is no opportunity to randomize participants to either the intervention or control groups. Time point measures will include pre-intervention (T0), and two follow up points (T1 and T2).
It is anticipated that 160 people living with dementia will take part in the study (respite intervention group n= 50; respite control group n=50; long term care intervention group n= 30; long term care control group n= 30). Other participants will include family or informal carers (n= 20) and staff delivering care (n=70).
The residential mode of the intervention will minimize cases of missing data. However, in the event of missing data, investigators will use Multiple Imputations Methods (MIM) if missing data are less than twenty percent (<20%). It is unlikely that data will be Missing Completely at Random (MCAR), but data Missing at Random will be assessed using appropriate statistical procedures such as analysis via the patterns command to determine patterns of missingness and their frequency and to examine variables predictive of missing data. Investigators will eliminate dropouts or noncompliance from analyses, if missing data are more than 20%. Similarly, if data are not Missing at Random, investigators will use last observation carried forward (LOCF) method particularly for participants in long term care to maintain the sample size and minimize confounding effects of noncompliance or attrition.
- Conditions
- Dementia
- Being tested
- CASCADE ways of working
- Keywords
- Dementia care, Community integrated care, Strengths-based approach, Technology, Person centered care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASCADE ways of workingOther
Also called Supportive care through CASCADE ways of working
Technology, learning and development resources and nursing and therapeutic care are the key drivers for the CASCADE ways of working promoting community integrated dementia care and support to optimise safety and independence for people living with dementia.
| Study group | Role | What they receive |
|---|---|---|
| People living with dementia intervention group | Experimental | Long term care and support are provided in a dementia care friendly environment with emphasis on 'the person's home'. Each resident's home carries a registered address to symbolise the person's home. Based on needs and strengths, people living with dementia and their families are supported to choose the technology to enable the person's independence plus developing new and maintaining existing skills. Examples of supportive and assistive technology include mobile devices, memory clocks, gas and flood detectors, sensor mats and global positioning system trackers or safe return ornaments. Routine care follows a holistic integrated health and social care plan tailored to the needs of the person living with dementia.
Respite care provided in guesthouse facilities embody a similar approach only for a shorter period of time without assigning registered home addresses. Receives: Other: CASCADE ways of working |
| People living with dementia control group | No intervention | People living with dementia in need of long-term rehabilitation or recovery for at least eight months; and people living with dementia in need of respite care for up to 14 days People living with dementia will continue to use standard care. Standard care in this respect constitutes usual health and social care or any other nationally acceptable form of therapy that people living with dementia would seek to use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Adjusted Life Years (QALYs)
The primary outcome will be Quality Adjusted Life Years (QALYs) for people living with dementia generated through the CASCADE ways of working. Health related quality of life will be measured using the EuroQol Group -Five Dimensions - Five-level scale (EQ-5D-5L). Results of EQ-5D-5L will be converted to utility values multiplied by the time spent in each state to generate QALYs. 1 QALY is equivalent to perfect health while less than perfect health carries a QALY between 0 and 1. A 0 QALY represents death. The higher the number of QALYs gained through the CASCADE model of care the better the health outcomes for people living with dementia.
Measured: 8 months
Resource utilisation in dementia
A Resource Utilization in Dementia (RUD) scale will be used to assess use of hospital beds and other health and social care specialist services as well as informal carer's time and health. Less health specialists care used and low or no hospitalisation episodes in the intervention group compared to the control group implies higher cost benefits resulting from the CASCADE ways of working.
Measured: 8 months
Secondary outcomes (2)
Quality of life of people living with dementia
Investigators will measure changes on the quality of life of people living with dementia in the intervention group using the Quality of Life in Alzheimer's Disease (QOL-AD) scale. The maximum score obtainable on the13 items scale is 52 while the lowest score is 13. The higher the score the better the quality of life.
Measured: 8 months
Quality of life of informal/ family carers
The Adult Carer Quality of Life (Ac-QoL) will be used to evaluate the quality of life of informal carers of people living with dementia in the intervention group. Scores on the Ac-QoL range from 0-120, higher scores showing better quality of life.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study startMay 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: Unanticipated delays including those caused by COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- The factorial model examines the effect of using technology (telehealth) and learning and development resources on the cost of delivering dementia care and the well being of people living with dementia, family carers and staff delivering care. The learning and development resources hosted in an accessible repository will comprise three modular training modules at three different levels of healthcare professionals, carers and the public. The training modules include principles of CASCADE, person centred leadership and learning climate (giving and receiving feedback). Technology
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Collaborators
- Interreg
- Responsible party
- Sponsor
- Investigators
- Anne Martin, Principal investigator, Canterbury Christ Church UniversityEleni Hatzidimitriadou, PhD, Study chair, Canterbury Christ Church University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258358
- Sponsor's protocol ID
- 2S02038
- Acronym
- CASCADE
- Status last verified
- Jul 2022
- First submitted
- 29 Jan 2020
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data underpinning results in publications, for example, data that underlie cost effectiveness of the intervention and health and wellbeing results for people living with dementia will be shared through publishing platforms. Individual participant datasets will be shared via a suitable public data repository. A description of the dataset shared and respective relationships will be included in the data repository. An evaluation study report will be made available through the Canterbury Christ Church University CASCADE project web page.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Community Areas of Sustainable Care and Dementia Excellence Model of Care
- ClinicalTrials.gov ID
- NCT04258358
- Acronym / sponsor ID
- CASCADE / 2S02038
- Conditions
- Dementia
- Keywords
- Dementia care, Community integrated care, Strengths-based approach, Technology, Person centered care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unanticipated delays including those caused by COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Collaborators
- Interreg
- Study start
- May 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 6 Feb 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.
The study evaluates the impact and cost effectiveness of community integrated dementia care. Some of the people living with dementia participating in the study will receive long term or respite care and support in the community tailored to CASCADE ways of working. Other people living with dementia participating in the study will continue to use standard care as usual. The terms 'CASCADE model of care' and 'CASCADE ways of working' are used here interchangeably as appropriate.
Detailed description
The CASCADE ways of working draw on the person's strengths to optimize safety and independent living in their community. The ways of working incorporate learning and development for all stakeholders to enhance interactions with people living with dementia; use of technology to improve access to specialist care as well as safety in the community; and holistic care tailored to the needs of the person to improve and maintain well being. These elements work in tandem to enable people living with dementia to engage in meaningful leisure and activities of daily living.
The evaluation study aims to explore the benefits of the CASCADE model of care (ways of working) on service users (people with dementia and their caregivers), staff and service providers. The evaluation comprises elements of outcome and process evaluation. The outcome evaluation involves quantitative measures of health, well being and cost benefits while the process evaluation explores intervention implementation procedures to find out what worked and how it worked. The CASCADE model of care assumes that using the person's strengths to guide holistic personalized dementia care is a sustainable approach to safe meaningful independent living and improving public perceptions.
Investigators will use a quasi-experiment to assess quantifiable benefits (health and well being outcomes and cost benefits) of the CASCADE model for people with dementia. This means, investigators will compare two groups of people with dementia including one that will receive care under the CASCADE model (intervention group) and the second group will not. The anticipation is that comparing the two groups will make benefits of people receiving care under the CASCADE ways of working more observable. Participants will not be allocated randomly to the study arms because service use will be dependent on assessed need for referrals and need and affordability for self-referred users. This implies there is no opportunity to randomize participants to either the intervention or control groups. Time point measures will include pre-intervention (T0), and two follow up points (T1 and T2).
It is anticipated that 160 people living with dementia will take part in the study (respite intervention group n= 50; respite control group n=50; long term care intervention group n= 30; long term care control group n= 30). Other participants will include family or informal carers (n= 20) and staff delivering care (n=70).
The residential mode of the intervention will minimize cases of missing data. However, in the event of missing data, investigators will use Multiple Imputations Methods (MIM) if missing data are less than twenty percent (<20%). It is unlikely that data will be Missing Completely at Random (MCAR), but data Missing at Random will be assessed using appropriate statistical procedures such as analysis via the patterns command to determine patterns of missingness and their frequency and to examine variables predictive of missing data. Investigators will eliminate dropouts or noncompliance from analyses, if missing data are more than 20%. Similarly, if data are not Missing at Random, investigators will use last observation carried forward (LOCF) method particularly for participants in long term care to maintain the sample size and minimize confounding effects of noncompliance or attrition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The factorial model examines the effect of using technology (telehealth) and learning and development resources on the cost of delivering dementia care and the well being of people living with dementia, family carers and staff delivering care. The learning and development resources hosted in an accessible repository will comprise three modular training modules at three different levels of healthcare professionals, carers and the public. The training modules include principles of CASCADE, person centred leadership and learning climate (giving and receiving feedback). Technology
| Arm | Type | Receives |
|---|---|---|
| People living with dementia intervention group | Experimental | Other: CASCADE ways of workingLong term care and support are provided in a dementia care friendly environment with emphasis on 'the person's home'. Each resident's home carries a registered address to symbolise the person's home. Based on needs and strengths, people living with dementia and their families are supported to choose the technology to enable the person's independence plus developing new and maintaining existing skills. Examples of supportive and assistive technology include mobile devices, memory clocks, gas and flood detectors, sensor mats and global positioning system trackers or safe return ornaments. Routine care follows a holistic integrated health and social care plan tailored to the needs of the person living with dementia. Respite care provided in guesthouse facilities embody a similar approach only for a shorter period of time without assigning registered home addresses. |
| People living with dementia control group | No intervention | –People living with dementia in need of long-term rehabilitation or recovery for at least eight months; and people living with dementia in need of respite care for up to 14 days People living with dementia will continue to use standard care. Standard care in this respect constitutes usual health and social care or any other nationally acceptable form of therapy that people living with dementia would seek to use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The person needs long-term rehabilitation or recovery for at least eight months.
- Specific inclusion criteria for guesthouse facilities
- The person needs emergency respite due to unforeseen circumstances
- In need of planned respite for example, due to informal carer's scheduled commitments
- The person needs short-term rehabilitation or recovery
Key exclusion criteria (3 listed)
- People with complex care needs that cannot be met at the project delivery sites during initial recruitment.
- People that will not consent to participate in the evaluation study.
- People living with dementia involved in other studies.
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 |
|---|---|---|
| CASCADE ways of workingAlso: Supportive care through CASCADE ways of workingTechnology, learning and development resources and nursing and therapeutic care are the key drivers for the CASCADE ways of working promoting community integrated dementia care and support to optimise safety and independence for people living with dementia. | Other | People living with dementia intervention group |
Primary outcome
Quality Adjusted Life Years (QALYs)
Time frame: 8 months
The primary outcome will be Quality Adjusted Life Years (QALYs) for people living with dementia generated through the CASCADE ways of working. Health related quality of life will be measured using the EuroQol Group -Five Dimensions - Five-level scale (EQ-5D-5L). Results of EQ-5D-5L will be converted to utility values multiplied by the time spent in each state to generate QALYs. 1 QALY is equivalent to perfect health while less than perfect health carries a QALY between 0 and 1. A 0 QALY represents death. The higher the number of QALYs gained through the CASCADE model of care the better the health outcomes for people living with dementia.
Resource utilisation in dementia
Time frame: 8 months
A Resource Utilization in Dementia (RUD) scale will be used to assess use of hospital beds and other health and social care specialist services as well as informal carer's time and health. Less health specialists care used and low or no hospitalisation episodes in the intervention group compared to the control group implies higher cost benefits resulting from the CASCADE ways of working.
2 secondary outcomes
Quality of life of people living with dementia
Time frame: 8 months
Quality of life of informal/ family carers
Time frame: 8 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 Jul 2022.
- Individual participant dataSharing planned: Yes. Anonymised data underpinning results in publications, for example, data that underlie cost effectiveness of the intervention and health and wellbeing results for people living with dementia will be shared through publishing platforms. Individual participant datasets will be shared via a suitable public data repository. A description of the dataset shared and respective relationships will be included in the data repository. An evaluation study report will be made available through the Canterbury Christ Church University CASCADE project web page.
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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.
Anne Martin principal investigator
Canterbury Christ Church University
Eleni Hatzidimitriadou, PhD study chair
Canterbury Christ Church University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CASCADE ways of working in people with Dementia, run by Canterbury Christ Church University at 2 sites 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 7 inclusion and 3 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 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Quality Adjusted Life Years (QALYs) (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2022.