Condition category
Mental and Behavioural Disorders
Date applied
26/09/2019
Date assigned
07/10/2019
Last edited
07/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Resilience refers to one’s ability to ‘bounce back’ and cope successfully in the face of life challenges. Strengthening the ability of people with dementia to bounce back in the face of a dementia diagnosis may provide the building blocks to create an environment that maximises their functioning, social connectedness and social performances. This study seeks to find out if it is possible to create such an environment.

Who can participate?
Older people over the age of 60 with memory problems/dementia who live at home in the community and their primary carers

What does the study involve?
All participants will receive a special programme of activities which will run over 15 weeks. These activities will have 3 key things:
1) A 7-week programme, (1 hour twice a week), for people with memory problems/dementia which consists of group activities, focused on promoting and maintaining their mental ability. There will be an average of 5 people in each group and the programme will be delivered by a health professional
2) An 8-week physical exercise programme, (1 hour per week for 4 weeks and 2 hours per week for 4 weeks), for people with memory problems/dementia delivered by an exercise expert. Participants will be supported by older people in the community to complete the exercises.
3) An educational programme which will have three parts (i) a 1 hour programme on dementia for members of the public delivered by a person trained in dementia care (ii) a 6 week educational programme for carers, (1 hour 40 mins a week), delivered by members of the research team (iii) a dementia training workshop for GP’s (1.5 hours) delivered by a GP trained in dementia care.

What are the possible benefits and risks of participating?
Taking part in this study will help us find out whether people with memory problems/dementia and their primary carers feel that the different activities are acceptable, that it is possible to deliver them in the community and that the way we measure the impact of the activities is not too difficult. The information we get will also help us plan a much larger study to gauge how effective the activities might be in helping people with memory problems/ dementia to live well with their dementia. It is not expected that people with memory problems/dementia and their carers will have any side effects from carrying out the different activities.

Where is the study run from?
National University of Ireland Galway, Ireland

When is the study starting and how long is it expected to run for?
The study commenced on 14th November 2016 and is due to end on 31st October 2020

Who is funding the study?
Health Research Board Ireland

Who is the main contact?
Priscilla Doyle (CREST Project Manager),
priscilla.doyle@nuigalway.ie
Prof. Dympna Casey (scientific contact),
dympna.casey@nuigalway.ie

Trial website

http://www.nuigalway.ie/crest/

Contact information

Type

Scientific

Primary contact

Prof Dympna Casey

ORCID ID

http://orcid.org/0000-0001-5341-597X

Contact details

School of Nursing & Midwifery
Áras Moyola
National University of Ireland Galway
Galway
H91 TK33
Ireland
+353 (0) 91 493652
dympna.casey@nuigalway.ie

Type

Public

Additional contact

Ms Priscilla Doyle

ORCID ID

Contact details

Room 338
School of Nursing & Midwifery
Áras Moyola
National University of Ireland Galway
Galway
H91 TK33
Ireland
+353 (0) 91 493611
priscilla.doyle@nuigalway.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

DEM-2015-1439

Study information

Scientific title

The feasibility of a Comprehensive Resilience-building psychosocial Intervention (CREST) for people with dementia living at home in the community

Acronym

CREST

Study hypothesis

To determine the feasibility of the CREST complex psychosocial intervention for people with dementia and their carers living in the community. Quantitative and qualitative feasibility assessment data will be collected to inform the decision to proceed with a future RCT and its optimal design

Ethics approval

Approved 01/08/2019, National University of Ireland, Galway Research Ethics Committee (Research Office, Research and Innovation Centre, National University of Ireland Galway, University Road, Galway, H91 TK33, Ireland; +353 (0) 91 495312; vpresearach@nuigalway.ie), ref: 16-Feb-03; Amend 1907

Study design

Non-randomised feasibility study

Primary study design

Interventional

Secondary study design

A non-randomised feasibility study

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet.

Condition

Dementia

Intervention

CREST is a multi-level complex psychosocial intervention. All participants will receive the intervention. The intervention will run over 15 weeks and is comprised of various interrelated components targeting different participants and will include:
1) A 14-hour cognitive stimulation programme ‘Making a difference’ delivered over 7 weeks (1 hour twice a week), to people living with dementia
2) A 12-hour physical exercise programme, delivered over 8 weeks, (1 hour a week for 4 weeks and 2 hours a week for 4 weeks), by an exercise specialist to people living with dementia who will be supported by older people from the community
3) A dementia education programme which consists of three elements (a) a 1 hour one-off Community dementia awareness programme, delivered by trained dementia/community champions to members of the public (b) a 10 hour, educational programme delivered over 6 weeks, (1 hour 40 mins a week), by members of the research team to the carers of people with dementia (c) a 1.5 hour one-off continuing professional development (CPD) and accredited GP workshop delivered by a trained GP facilitator

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Number and proportion of participants (people with dementia, caregivers) who are screened, judged eligible and agreed to take part in the study
2. Follow up rates outcome completion and adherence/compliance
3. Reasons for non-recruitment, non-adherence or attrition
4. Feasibility and acceptability of the intervention content, delivery, and fidelity assessments
5. Acceptability of the recruitment process, assessments, data collection tools, intervention content & delivery
6. Willingness of key gatekeepers to recruit participants (people with dementia and caregivers)
7. Calculate baseline score and variability of secondary outcome measures among participants
8. Evaluation of the cost analysis process
9. Identification of barriers and enablers to stigma change in dementia
10. Identification of optimal strategy for recruitment of participants for future definitive trial

Secondary outcome measures

The feasibility and acceptability of the following secondary outcome measurement tools will also be explored:

1. Completed by carers pre and post the 15-week intervention:
1.1 Zarit Carer burden interview (ZBI) to assess the level of burden
1.2 Short sense of Competency Scale (SSCS) to measure the sense of competence
1.3 Dementia Knowledge 20 (DK20) to measure knowledge of dementia
1.4 Resource Utilisation in Dementia – (RUD-lite) to measure healthcare resource utilisation
1.5 Adult carer quality of life (AC-QoL) to measure the overall quality of life of adult carers

2. Completed by people with dementia pre and post the 15-week intervention:
2.1 Mini Mental State Examination (MMSE) to screen for dementia and measure changes in cognitive function
2.2 Quality of Life- Alzheimer’s Disease (QoL-AD) to measure Quality of Life
2.3 Stigma Impact Scale (SIS) to measure self-perceived levels of stigma
2.4 Positive Psychology Outcome Measure (PPOM) to measure resilience
2.5 EQ-5D-5L to measure health status for economic appraisal
2.6 Fitbit to measure sleep quality and physical activity
2.7 The Geriatric Depression Scale – Short Form (GDS-S) to measure depression in older adults.

3. Completed by members of the public pre and post 15-week intervention:
3.1 Dementia Attitudes Scale (DAS) to measures attitudes towards dementia
3.2 Dementia Knowledge 20 (DK-20) to measure knowledge of dementia

Overall trial start date

14/11/2016

Overall trial end date

31/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. People with dementia (of any gender):
1.1 > 60 years of age
1.2 Have either
1.2.1 A formal diagnosis of dementia (mild to moderate dementia)
1.2.2 Their GP believes they have memory problems and the person has a provisional diagnosis of dementia based on the DSM-IV criteria
1.2.3 Are prescribed dementia medications
1.3 Living in the community
1.4 Willing and capable of undertaking the exercise component of the intervention
1.5 Able to speak in and read English
1.6 Able to give informed consent
1.7 Their primary caregiver is also willing to take part in the study

2. Carers of People with dementia (of any gender):
2.1 Primary caregiver of a person with dementia who has also agreed to participate in the study
2.2 Does not have a diagnosis of dementia
2.3 Living in the community
2.4 Willing and able to participate in the 6 weeks Caregiver education programme
2.5 Able to speak in and read English
2.6 Able to give informed consent

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

A total A total of 20 participants - 10 people with mild to moderate dementia and their primary informal carers (n=10)

Participant exclusion criteria

Not meeting the inclusion criteria

Recruitment start date

25/02/2019

Recruitment end date

13/10/2019

Locations

Countries of recruitment

Ireland

Trial participating centre

School of Nursing & Midwifery
National University of Ireland Galway University Road
Galway
H91 TK33
Ireland

Trial participating centre

Ballinfoile Castlegar Neighbourhood Centre
Ballinfoile
Galway
H91PN50
Ireland

Sponsor information

Organisation

National University of Ireland Galway

Sponsor details

University Road
Galway
H91 TK33
Ireland
+353 (0) 91 493652
dympna.casey@nuigalway.ie

Sponsor type

University/education

Website

http://www.nuigalway.ie

Funders

Funder type

Government

Funder name

Health Research Board

Alternative name(s)

HRB

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Ireland

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer-reviewed journal

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/10/2019: Trial’s existence confirmed by National University of Ireland, Galway Research Ethics Committee.