NCT04258358

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

January 29, 2020

Last Update Submit

July 19, 2022

Conditions

Keywords

Dementia careCommunity integrated careStrengths-based approachTechnologyPerson centered care

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Quality of life of people living with dementia

    8 months

  • Quality of life of informal/ family carers

    8 months

Other Outcomes (2)

  • Well being of staff delivering care

    8 months

  • Cost effectiveness

    8 months

Study Arms (2)

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.

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.

Interventions

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.

Also known as: Supportive care through CASCADE ways of working
People living with dementia intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- The person needs long-term rehabilitation or recovery for at least eight months.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

East Kent Hospitals University National Health Service Foundation Trust

Canterbury, Kent, CT1 3NG, United Kingdom

Location

Medway Community Healthcare

Rochester, Kent, United Kingdom

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Anne Martin

    Canterbury Christ Church University

    PRINCIPAL INVESTIGATOR
  • Eleni Hatzidimitriadou, PhD

    Canterbury Christ Church University

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 6, 2020

Study Start

May 1, 2022

Primary Completion

November 1, 2022

Study Completion

January 1, 2023

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
It is anticipated the study protocol will be published in a suitable journal by December 2020. Individual participant data sets relating to the study will be made available via an appropriate data repository starting 6 months after formal publication of results. The evaluation study report will be available on Canterbury Christ Church University CASCADE project web page by April 2021.
Access Criteria
Anonymised data sets unpinning publications will be shared through the control measures of the publishing journals such as full access to subscribers

Locations