Plain English Summary
Background and study aims
The researchers carried out interviews and observations with family carers, people living with dementia and professionals on what helps and hinders independence at home. They used their findings to co-produce an intervention for people with dementia and their family carers to improve the support received by people living with dementia in their own homes. They now wish to pilot this intervention to see how acceptable and feasible it is to deliver in practice from the family carer, person with dementia and researcher perspectives.
Who can participate?
Family carers and people with a dementia diagnosis who live at home
What does the study involve?
A trained researcher delivers the intervention to family carers/people living with dementia in up to eight sessions over a six-month period. The intervention is tailored to each individual's preferences and needs and involves setting and monitoring progress with goals and priorities, signposting people to existing resources and services, and identifying activities that participants can take part in to help them achieve their goals. Participants are asked to complete questionnaires on goal attainment, quality of life, activities of daily living, symptoms and service use. Participants and researchers are asked about their experiences of delivering and receiving the intervention.
What are the possible benefits and risks of participating?
There may be no direct benefit to taking part in the study, but by taking part, participants are contributing to the development of an intervention that may help family carers and people living with dementia to be independent at home for longer. Their experiences of receiving the intervention will be used to modify it before it is tested in a larger study. No risks are foreseen, but it is possible that some topics discussed may be upsetting if participants are finding it difficult to be independent at home.
Where is the study run from?
1. Camden and Islington NHS Foundation Trust (UK)
2. Bradford District Care NHS Foundation Trust (UK)
3. South West Yorkshire Partnership NHS Foundation Trust (UK)
4. Westcliffe Medical Centre (UK)
When is the study starting and how long is it expected to run for?
December 2018 to February 2020 (updated 02/06/2020, previously: May 2020)
Who is funding the study?
Alzheimer's Society (UK)
Who is the main contact?
Jessica Budgett
j.budgett@ucl.ac.uk
(updated 02/06/2020, previously:
Alexandra Burton
a.burton@ucl.ac.uk)
Trial website
Contact information
Type
Scientific
Primary contact
Ms Jessicca Budgett
ORCID ID
Contact details
University College London
Maple House 6th Floor Wing A
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
+44 (0)2076799031
j.budgett@ucl.ac.uk
Type
Scientific
Additional contact
Prof Claudia Cooper
ORCID ID
http://orcid.org/0000-0002-2777-7616
Contact details
UCL Division of Psychiatry
Maple House
6th Floor
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
+44 (0)203 549 5875
claudia.cooper@ucl.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
41451
Study information
Scientific title
Assessing the feasibility and acceptability of a psychological intervention for family carers and people living with dementia in their own homes: a feasibility study for stream two of the NIDUS (New interventions for Independence in Dementia) programme
Acronym
Study hypothesis
To determine the feasibility and acceptability of a psychological intervention (NIDUS-family) for maintaining independence at home for people with dementia and their family carers through:
1. Piloting recruitment and assessment processes for the planned full trial of the intervention
2. Exploring family carers’ and people living with dementia’s experiences of receiving the intervention, and researchers’ experiences of delivering it by conducting semi-structured qualitative interviews and using the findings to refine the intervention for the full trial
3. Evaluating intervention acceptability to family carers, through qualitative methods and completion of a semistructured questionnaire
4. Assessing fidelity of delivery of the manualised intervention
Ethics approval
Approved 25/04/2019, London - Camden & Kings Cross Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH, UK; Tel: +44 (0)20 7972 2561; Email: nrescommittee.london-camdenandkingscross@nhs.net), ref: 19/LO/0423, IRAS project ID: 259249
Study design
Non-randomised; Interventional; Design type: Treatment, Education or Self-Management, Psychological & Behavioural, Complex Intervention
Primary study design
Interventional
Secondary study design
Non randomised study
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
The study will recruit 15 family carers and people with a dementia diagnosis who live at home through NHS memory services and GP practices. A trained researcher will deliver the intervention to family carers/people living with dementia in up to eight sessions over a six-month period. The intervention will be tailored to each individual's preferences and needs and will involve setting and monitoring progress with goals and priorities, signposting people to existing resources and services and identifying activities that participants can take part in to help them achieve their goals. Participants will be asked to complete questionnaires on goal attainment, quality of life, activities of daily living, symptoms and service use. Participants and researchers will be asked about their experiences of delivering and receiving the intervention.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
There is no primary outcome measure as it is a feasibility study but the study will be measuring:
1. The proportion of eligible people approached who agreed to take part in the study, measured at the end of the recruitment period (month 3)
2. Acceptability of the intervention measured using qualitative interviews and a 5-point Acceptability Likert Scale at 6 months
3. Fidelity to intervention delivery, measured using a fidelity analysis of audio-recordings of intervention appointments over a 6-month period
Secondary outcome measures
The outcome measures being piloted are:
1. Functioning of the person with dementia measured using Goal Attainment Scaling (GAS) (primary outcome in the full RCT)
2. Functional independence (basic and instrumental activities of daily living) measured using Disability Assessment for Dementia scale
3. Quality of life of the person with dementia measured using DEMQOL or DEMQOL proxy
4. Neuropsychiatric symptoms measured using Neuropsychiatric inventory
5. Family carer quality of life measured using C-DEMQOL & Carerqol
6. Family carer burden measured using Zarit Burden Inventory
7. Family carer anxiety and depression measured using Hospital Anxiety and Depression Scale
8. Health and social care service use measured using Client Services Receipt Inventory
9. Potentially abusive behaviour measured using Modified Conflict Tactics Scale
All measured at baseline and 6 months
Overall trial start date
01/12/2018
Overall trial end date
29/02/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. People with a documented diagnosis of dementia of any severity who are living in their own homes: alone and with others, and who have a family carer willing to participate in the study
2. Family carers who are in regular (at least weekly face-to-face or telephone contact) with the person with dementia
3. Family carers who can speak English
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 30; UK Sample Size: 30
Total final enrolment
38
Participant exclusion criteria
1. People living with dementia who are receiving palliative care support and considered to be in the last 6 months of their life
2. Family carers who lack capacity to consent
Recruitment start date
01/05/2019
Recruitment end date
30/09/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Camden and Islington NHS Foundation Trust
St. Pancras Hospital
4 St. Pancras Way
London
NW1 0PE
United Kingdom
Trial participating centre
Bradford District Care NHS Foundation Trust
New Mill
Victoria Road
Saltaire
Shipley
Bradford
BD18 3LA
United Kingdom
Trial participating centre
South West Yorkshire Partnership NHS Foundation Trust
Trust Headquarters
Fieldhead
Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom
Trial participating centre
Westcliffe Medical Centre
157 Westcliffe Rd
Shipley
Bradford
BD18 3EE
United Kingdom
Sponsor information
Organisation
University College London
Sponsor details
Joint Research Office
Maple House 1st Floor
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
+44 (0)20 3447 5557
uclh.randd@nhs.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Alzheimer's Society; Grant Codes: AS-PR2-16-002
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
1. The researchers will feedback a summary of the results to participants if they indicate that they would like to receive this
2. They will write up the findings for publication in a peer-reviewed journal and for conference presentations
IPD sharing statement
The data-sharing plans for the current study are unknown and will be made 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