Evaluating the Community Areas of Sustainable Care and Dementia Excellence Model of Care

Dementia Clinical Trial

— CASCADE  

Official title:

Evaluating the Community Areas of Sustainable Care and Dementia Excellence Model of Care

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04258358
• Other study ID #: 2S02038
• Status: Withdrawn
• Phase: N/A
• Start date: May 2022
• Est. completion date: January 2023

Study information

• Verified date: July 2022
• Source: Canterbury Christ Church University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	East Kent Hospitals University National Health Service Foundation Trust	Canterbury	Kent
United Kingdom	Medway Community Healthcare	Rochester	Kent

Sponsors (2)

Lead Sponsor	Collaborator
Canterbury Christ Church University	Interreg 2 Seas Mers Zeeën

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Well being of staff delivering care	The Strain and Emotional Reaction in Dementia Care scale will be used to evaluate the impact of CASCADE ways of working on staff's well being. The scale comprises three domains assessing perceptions of behavior of people living with dementia evaluated on Likert scales.; Positive attitude towards behavioural experiences, assessment of emotions and ease of handling challenges during care processes indicate greater wellbeing of staff delivering care and meaningful caring relationships.	8 months
Other	Cost effectiveness	The cost of Quality Adjusted Life Years (QALYs) of people living with dementia in the intervention group will be compared with the control group to illustrate cost effectiveness of the CASCADE ways of working. Incremental Cost Effectiveness Ratio (ICER) will represent the additional cost per unit of QALY to indicate the trade-off between total cost and effectiveness of the CASCADE intervention compared to standard care.	8 months
Primary	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.	8 months
Primary	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.	8 months
Secondary	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.	8 months
Secondary	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.	8 months