Clinical trial NCT04258358: Evaluating the Community Areas of Sustainable Care and Dementia Excellence Model of Care
Official title: Evaluating the Community Areas of Sustainable Care and Dementia Excellence Model of Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dementia
Keywords: Dementia care
Community integrated care
Strengths-based approach
Technology
Person centered care
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
Collaborators: name: Interreg
First posted: 2020-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality Adjusted Life Years (QALYs)
timeFrame: 8 months
measure: Resource utilisation in dementia
timeFrame: 8 months
Secondary outcomes:
measure: Quality of life of people living with dementia
timeFrame: 8 months
measure: Quality of life of informal/ family carers
timeFrame: 8 months
Other outcomes:
measure: Well being of staff delivering care
timeFrame: 8 months
measure: Cost effectiveness
timeFrame: 8 months
Locations:
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals University National Health Service Foundation Trust
state: Kent
city: Rochester
country: United Kingdom
facility: Medway Community Healthcare
state: Kent
Study officials:
affiliation: Canterbury Christ Church University
name: Anne Martin
role: PRINCIPAL_INVESTIGATOR
affiliation: Canterbury Christ Church University
name: Eleni Hatzidimitriadou, PhD
role: STUDY_CHAIR
References: