Condition category
Mental and Behavioural Disorders
Date applied
22/10/2018
Date assigned
23/10/2018
Last edited
11/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Protocol

Plain English Summary

Background and study aims
The researchers are looking at ways to better support people with early stage dementia in their home and in the community. The research is for people who have been diagnosed with early stage dementia who would like to maintain or increase their independence and participation in activities. The researchers would like to find out what help people with dementia currently get to support independence and participation, and develop a programme that could be effective in addressing these issues. The programme called Promoting Independence in Dementia (PRIDE) will provide information, advice and support on the maintenance of pleasure, independence, and relationships. It is not known whether a programme of this kind could work and a large study is needed to test it. Before doing a large study, the aim of this study is to find out the best way to carry out the research, see what people with dementia think about the programme, and check that there would be enough people interested in taking part.

Who can participate?
People aged 18 or over with mild dementia recruited from NHS sites providing dementia services

What does the study involve?
Participants are allocated at random to one of two groups; one group is offered the PRIDE programme in addition to usual care and one group carries on with usual care as provided by their NHS Trust. Participants complete assessments and questionnaires at the start of the study and again after 3 and 6 months. Some people are also invited to take part in focus group interviews about their experiences of the programme and the research.

What are the possible benefits and risks of participating?
If the study is successful the researchers would then apply for funding to do a much larger study in the future. The information from this research will help them to plan and carry out the larger study to evaluate how best to support people with early stage dementia and improve care in the future.

Where is the study run from?
1. Central and North West London NHS Foundation Trust (UK)
2. Derbyshire Healthcare NHS Foundation Trust (UK)
3. Humber Teaching NHS Foundation Trust (UK)
4. Leicestershire Partnership NHS Trust (UK)
5. North West Boroughs Healthcare NHS Foundation Trust (UK)
6. Oxford Health NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
September 2018 to June 2020 (updated 11/03/2020, previously: February 2020)

Who is funding the study?
Economic and Social Research Council (UK)

Who is the main contact?
Mrs Aisha Shafayat
pride@nottingham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Aisha Shafayat

ORCID ID

Contact details

Nottingham Clinical Trials Unit
School of Medicine
University of Nottingham
C Floor
South Block
Queen’s Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 8231578
pride@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

39076

Study information

Scientific title

Promoting independence in dementia (PRIDE): a feasibility randomised controlled trial of the PRIDE intervention for people with mild dementia

Acronym

PRIDE

Study hypothesis

To investigate the feasibility and acceptability of conducting a randomised controlled trial (RCT) to compare the clinical and cost effectiveness of the PRIDE intervention delivered in addition to usual care with usual care only for people with mild dementia.

Ethics approval

West Midlands - Solihull Research Ethics Committee, 18/10/2018, ref: 18/WM/0281

Study design

Randomised; Both; Design type: Treatment, Education or Self-Management, Psychological & Behavioural, Complex Intervention, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

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

Condition

Dementia

Intervention

Identification of potential participants
Potential participants will be invited to take part by their usual care team, or may become aware of the study through Join Dementia Research or publicity through other relevant groups and organisations. All potential participants will be provided with a copy of the written participant information sheet and the researcher will arrange to visit the potential participant at home if they remain interested in taking part.

Visit 1
At the first visit, the researcher will explain the study and obtain written consent from the participant. Basic demographic information will be collected and an initial assessment will be done to confirm if the participant is eligible to be randomised. If the participant is found not to be eligible to take part after this assessment, the researcher will explain this and will provide a brief report of the results, if this is requested. If the participant is eligible to take part, the researcher will continue with the visit and complete the baseline assessments and questionnaires. This visit should take no more than 90 minutes in total.
The participant can also choose a supporter to take part in the study with them. The supporter will fill out questionnaires and will support the participant during the PRIDE programme. If a supporter would like to take part, they will be asked to be present and provide consent at the first visit.

Randomisation
When the first visit has been completed, and the participant is confirmed as suitable, they will be randomly allocated to receive the PRIDE programme and usual care or their usual care only. Participants will be individually allocated on a 1:1 ratio using minimisation with a probabilistic element. The minimisation variables will be study site, sex, age (< 80 or ≥ 80) and medication for dementia (any versus none).

Intervention phase
If the participant is allocated to receive the PRIDE programme, they will be offered 3 sessions, supported by a trained facilitator who works for the NHS. Each session will be carried out in the participants’ home on a monthly basis. Each session will last approximately 60-90 minutes, and will follow a manual which contains chapters on how to promote independence and facilitates living well with dementia.
If the participant is allocated to receive usual care then they will not be offered these additional sessions, but their usual care will continue.

Follow-up
All participants will be invited to attend follow-up visits 3 months and 6 months after randomisation. A researcher will carry out the follow-up visits in the participant’s home. The researcher will complete assessments and questionnaires with the participant which should take no more than 60-90 minutes.

Participants may also be invited to take part in qualitative focus group interviews, which will ask more about their experiences of taking part in the trial, the PRIDE intervention and usual care.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The feasibility of conducting a full RCT related to participant recruitment and follow-up, intervention delivery including the recruitment, training and retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures.

Secondary outcome measures

The following clinical outcomes will be measured to assess the relevance and acceptability of these outcomes for use in a future definitive RCT and to obtain information to inform selection of the primary outcome measure for a future trial. All outcomes are assessed at baseline, 3 and 6 month follow-up.
1. Activities of daily living measured using the Lawton Instrumental Activities of Daily Living (IADL) Scale
2. Health-related quality of life measured using the EuroQoL Quality of Life Questionnaire – 5 Domains, 5 Levels (EQ-5D-5L)
3. Quality of life measured using the DEMQOL
4. Mood measured using the Geriatric Depression Scale (GDS)
5. Cognition measured using the Standardised Mini Mental State Exam (S-MMSE)
6. Wellbeing measured using the Control, Autonomy, Self-realisation and Pleasure (CASP)
7. Quality of relationships measured using the Social Relationships sub-scale of the Impact on Participation and Autonomy Questionnaire for older people (IPAQ-O)
8. Positive emotions measured using the Positive Psychology Outcome Measure (PPOM)
9. Social engagement measured using the number of social contacts and leisure activities per week
10. Global rating of change assessed by the person with dementia and the supporter
11. Resource use measured using a modified version of the Client Service Receipt Inventory (CSRI)

Overall trial start date

01/09/2018

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Inclusion criteria for the person with dementia:
To be eligible for the trial participants must meet all of the following inclusion criteria:
1. ­Resident within the catchment area of one of the participating NHS sites
2. ­Aged 18 or over; there is no upper age limit
3. ­Meet the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for dementia of any type, including Alzheimer’s, vascular, Lewy body type and mixed
4. ­Able to engage with and participate in the intervention in the judgement of the investigator or designee
5. ­Able to provide informed consent in the judgement of the investigator or designee
6. Able to read and communicate verbally in English
In addition, to be eligible for randomisation, the following inclusion criteria must be met. This is ascertained by a formal screening assessment completed after consent:
7. ­Mild dementia, defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale. The CDR will be completed during a face-to-face visit, as a post-consent screening assessment to determine eligibility for randomisation.

Inclusion criteria for the supportive other:
Note that participation of a supportive other is not mandatory and will be at the discretion of the participant. If the participant chooses to identify a supportive other they wish to participate with, the following inclusion criteria will apply:
1. Aged 18 or over; there is no upper age limit
2. ­Able to engage with and participate in the intervention
3. ­Able to provide informed consent
4. Able to read and communicate verbally in English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

Total final enrolment

92

Participant exclusion criteria

Exclusion criteria for the person with dementia:
­Living in institutional care

Recruitment start date

15/11/2018

Recruitment end date

30/06/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Central and North West London NHS Foundation Trust
NW1 3AX
United Kingdom

Trial participating centre

Derbyshire Healthcare NHS Foundation Trust
DE22 3LZ
United Kingdom

Trial participating centre

Humber Teaching NHS Foundation Trust
HU10 6ED
United Kingdom

Trial participating centre

Leicestershire Partnership NHS Trust
LE4 8PQ
United Kingdom

Trial participating centre

North West Boroughs Healthcare NHS Foundation Trust
WA2 8WA
United Kingdom

Trial participating centre

Oxford Health NHS Foundation Trust
OX3 7JX
United Kingdom

Sponsor information

Organisation

University of Nottingham

Sponsor details

c/o Ms Angela Shone
Head of Research Governance
Research and Innovation
University of Nottingham
East Atrium
Jubilee Conference Centre
Triumph Road
Nottingham
NG8 1DH
United Kingdom
+44 (0)115 8467906
sponsor@nottingham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Economic and Social Research Council; Grant Codes: ES/L001802/2

Alternative name(s)

ESRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from the trial coordinating centre (Nottingham Clinical Trials Unit, pride@nottingham.ac.uk).

Intention to publish date

28/02/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/31829232 (added 13/12/2019)

Publication citations

Additional files

Editorial Notes

11/03/2020: The following changes were made to the trial record: 1. The overall end date was changed from 29/02/2020 to 30/06/2020. 2. The plain English summary was updated to reflect these changes. 13/12/2019: Publication reference added. 05/07/2019: The total final enrolment was added. 25/03/2019: The condition has been changed from "Specialty: Dementias and Neurodegeneration, Primary sub-specialty: Dementia; Health Category: Mental health, Neurological; Disease/Condition: Organic, including symptomatic, mental disorders, Other degenerative diseases of the nervous system" to "Dementia" following a request from the NIHR.