Condition category
Mental and Behavioural Disorders
Date applied
01/04/2019
Date assigned
01/05/2019
Last edited
01/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 May 2020

Who is funding the study?
Alzheimer's Society (UK)

Who is the main contact?
Alexandra Burton
a.burton@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Alexandra Burton

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
a.burton@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

Approval pending, London - Camden & Kings Cross Research Ethics Committee, ref: 19/LO/0423

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

01/05/2020

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

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

31/07/2019

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

professional associations and societies

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

01/05/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/04/2019: Trial's existence confirmed by the NIHR.