Journeying through dementia: exploring the clinical and cost-effectiveness of a group self-management intervention for people in the early stages of dementia
| ISRCTN | ISRCTN17993825 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17993825 |
| Secondary identifying numbers | 31981 |
- Submission date
- 26/09/2016
- Registration date
- 11/10/2016
- Last edited
- 11/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Dementia is a common condition in the aging population. People with dementia have difficulties with mental processes such as memory, language, reasoning and identifying people and objects, which become progressively worst over time. In 2009 the UK government introduced the establishment of memory services in each health locality so that people experiencing symptoms of dementia can access expert diagnosis and help. The drive for earlier and better diagnosis continues, and was emphasised in the Prime Ministers Challenge on dementia. However the availability of services following early diagnosis has not kept pace. Some memory services provide assistance following diagnosis but others offer little more than medication. This may be because until recently, people only received help in the later stages of the condition or that some felt that nothing could be done to stop the condition after a person had been diagnosed. This view is now changing due to the availability of medication to alleviate symptoms combined with a growing societal movement to raise awareness and promote living well with dementia. Additionally there is a recent realisation that people with the condition can be helped to be independent for longer. Nevertheless, extent of unmet need among those who receive an early diagnosis is significant. This project involves examining the effectiveness of an intervention called Journeying through Dementia for those who are in the early stages of dementia. This program has been developed to help people to self-manage their condition and live their lives. The aim of this study is to explore the effectiveness and cost-effectiveness of the Journeying through Dementia program.
Who can participate?
Patients in the early stages of dementia. Participants can also choose for their supporter e.g. family member or friend (sometimes referred to as a carer) to also participate but this is not essential.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group continue to receive usual care for the duration of the study. Those in the second group also continue to receive their usual treatment as well as the Journeying through Dementia program. This consists of 12 1.5-hour long weekly group sessions and 4 individual sessions, all with trained NHS Facilitators. As part of the sessions people explore self-management techniques, with an emphasis on re-engagement with hobbies and interest. At the start of the study and then after eight and twelve months, participants in both groups complete a number of questionnaires in order to assess their quality of life and self-management skills.
What are the possible benefits and risks of participating?
The main benefit everyone participating in the trial will receive is the knowledge that they are supporting research which will help inform how to improve support to people in the early stages of their dementia. Those attending the Journeying through Dementia intervention may have additional benefits such as an improvement in self-management, however at this stage it is not known if the program is beneficial. There are no known risks involved with participating.
Where is the study run from?
13 NHS trusts across the North and East Midlands of England (UK)
When is the study starting and how long is it expected to run for?
December 2015 to May 2019
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Jessica Wright
Jessica.Wright@sheffield.ac.uk
Contact information
Public
School of Health and Related Research
University of Sheffield
Regent Court
Regent Street
Sheffield
S1 4DA
United Kingdom
| Phone | +44 (0)114 222 4304 |
|---|---|
| Jessica.Wright@sheffield.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Education or Self-Management, Psychological & Behavioural, Complex Intervention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial of the clinical and cost-effectiveness of the Journeying through Dementia intervention compared to usual care |
| Study acronym | JtD |
| Study objectives | The aim of this study is to evaluate the effectiveness and cost-effectiveness of a self-management group intervention called Journeying through Dementia, for people in the early stages of dementia. |
| Ethics approval(s) | Leeds East National Research Ethics Service Board, 01/07/2016, ref: 16/YH/0238 |
| Health condition(s) or problem(s) studied | Specialty: Dementias and neurodegeneration, Primary sub-specialty: Dementia; UKCRC code/ Disease: Neurological/ Other disorders of the nervous system |
| Intervention | Participants will be randomised on a 1:1 basis using a centrally based computer programme. Intervention group: Participants receive the Journeying through Dementia intervention as well as usual care. The intervention consists of 12 weekly facilitated group sessions with 8-12 participants (all in the early stages of dementia) over 12 successive weeks, occasionally there may be a week’s break, for example due to a bank holiday. As part of the intervention, each participant also receives four individual sessions with one of the two facilitators to pursue their individual goals. The first individual session takes place before the commencement of the group and introduces the participant to one of the facilitators and enables discussion about their forthcoming involvement. The other three sessions are spaced over the 12 weeks including one at the end of the group sessions. The content of the intervention includes (but is not limited to) the following topics: 1. Ways of thinking about dementia: What is dementia, effects on everyday life, challenging stereotypes, sharing coping strategies 2. Keeping physically well Relationship between physical and mental wellbeing, embedded health activity in everyday life, diet 3. Memory Strategies to aid memory, impact on everyday life and learn and practice new techniques 4. Keeping mentally well Relationship between anxiety and memory and dementia and stress 5. Endings Celebration of achievements and how to move forward There is flexibility within the intervention to select different topics and explore topics in the level of detail dictated by the group for example some groups may spend more time on memory with another group spending more time on keeping mentally well.. One essential component is enactment of activities, particularly in the community with participants being encouraged to support each other. Participants are able to invite a supporter (e.g. family member, friend or neighbour) to participate in the group during sessions 1, 6 and 12, and in the individual sessions if the participant finds this helpful in achieving their goals. This is optional, e.g they do not have to bring along anyone. Nor does it have to be the same person each time or the participating supporter (if there is one). The intervention is facilitated by two relevant NHS staff members experienced with working with people with dementia. Facilitators need to be at least a Band 3 on the Agenda for Change scale. Examples of relevant staff include nurses, occupational therapists, psychologists, social workers, occupational therapy assistants, assistant psychologists and support workers. Facilitators do not have to be registered health care professionals (HCPS). Additional staff will be trained in the intervention to provide cover for annual leave and sickness absence. Facilitators at each site will initially receive a two day training course from Dr Claire Craig who devised the intervention. They will then be supported and supervised within their trust by someone experienced in supervision. This will usually be a HCP or social care professional who is a Band 7 on the NHS Agenda for Change scale. For example, someone who is a clinical psychologist or occupational therapist. The supervisors will receive supervision from a member of the trial team. Control group: Participants receive treatment as usual for the duration of the study. Both groups will be followed-up for a year, with outcome measure collection at 8 and 12 months post-randomisation. |
| Intervention type | Other |
| Primary outcome measure | Dementia related quality of life is measured using the DEMQOL questionnaire at baseline and 8 months. |
| Secondary outcome measures | 1. Dementia related quality of life measures using the DEMQOL questionnaire at baseline and 12 months. 2. Mood, specifically symptoms of depression is measured using the Patient Health Questionnaire (PHQ-9) at baseline and 8 months 3. Mood, specifically symptoms of anxiety is measured using the Generalized Anxiety Disorder 7 questionnaire (GAD-7) at baseline and 8 months 4. Quality of life is measured using the EQ-5D-5L questionnaire at baseline, 8 and 12 months 5. Self-efficacy (sense of control of one’s life) is measured using the General Self-Efficacy Scale at baseline and 8 months 6. Having the skills to self-manage is measured using the Self-Management Ability Scale at baseline and 8 months 7. A person’s wellbeing is measured using the Diener’s Flourishing Scale at baseline and 8 months 8. A person’s ability to perform functional tasks is measured using the Instrumental Activities of Daily Living at baseline and 8 months 9. Health and social care service use including medication is measured using the Health and Social Care Resource Use Questionnaire a, 8 and 12 months. This is to inform the cost effectiveness analysis 10. Family and friends' ability to support someone with dementia is being measured by the Sense of Competency in Caregiving questionnaire administered at baseline and 8 months to people supporting the participant |
| Overall study start date | 01/12/2015 |
| Completion date | 30/11/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 486; UK Sample Size: 486 |
| Total final enrolment | 519 |
| Key inclusion criteria | People with dementia: 1. People diagnosed with dementia for example Alzheimer’s disease, vascular dementia or mixed Alzheimer’s/vascular dementia 2. A Mini Mental State Examination (MMSE) score of 18 or over (conducted less than 2 months pre consent) 3. Can make informed decisions (assessed by the Capacity Assessment Form) 4. Living in the community or in sheltered accommodation, alone or with others 5. Able to converse and communicate in English 6. Willing to engage in a 12 week group self-management intervention Supporters (carers of a person with dementia): 1. Aged 18 years or older 2. Named by the person with dementia as their supporter 3. Able to converse and communicate in English 4. Ability to give informed consent |
| Key exclusion criteria | People with dementia: 1. Not been diagnosed with a form of dementia 2. Being in more moderate stages of dementia. Measured by having a MMSE score of < 18 3. Is assessed as lacking capacity (assessed by the Capacity Assessment Form) 4. Living in residential or nursing care 5. Not able to converse or communicate in English 6. Is taking part in any other pharmacological or psychosocial intervention studies Supporters: 1. Under 18 years old 2. The person with dementia they provide support to is not participating in the trial 3. Unable to converse or communicate in English 4. Unnot able to give informed consent |
| Date of first enrolment | 01/11/2016 |
| Date of final enrolment | 28/08/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Sheffield
S10 3TH
United Kingdom
2-8 St Martins Avenue
Bradford
BD7 1LG
United Kingdom
Leeds
LS15 8ZB
United Kingdom
Porchester Road
Nottingham
NG3 6AA
United Kingdom
Bridge Park Road
Thurmaston
Leicester
LE4 8PQ
United Kingdom
Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom
Edward Pease Way
Darlington
DL2 2TS
United Kingdom
Beverley Road
Willerby
HU10 6ED
United Kingdom
Lincoln
LN1 1FS
United Kingdom
London Road
Kettering
NN15 7PW
United Kingdom
Stoke-on-Trent
ST4 8HH
United Kingdom
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
Gosforth
Newcastle upon Tyne
NE3 3XT
United Kingdom
Sponsor information
Hospital/treatment centre
Fulwood House
Old Fulwood Road
Sheffield
S10 3TH
England
United Kingdom
"ROR" |
https://ror.org/05cn4v910 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The findings of the trial will be actively publicised and disseminated. The main trial findings are likely to be published in 2020. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the Chief Investigator Professor Gail Mountain (G.Mountain@bradford.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | qualitative study results | 04/02/2021 | 15/02/2021 | Yes | No |
| Other publications | fidelity assessment | 11/02/2021 | 18/02/2021 | Yes | No |
| Other publications | trial challenges | 29/01/2020 | 18/02/2021 | Yes | No |
| Protocol article | protocol | 13/09/2019 | 18/02/2021 | Yes | No |
| Results article | DEMQOL instrument results | 01/06/2021 | 14/06/2021 | Yes | No |
| Basic results | 09/08/2021 | 09/08/2021 | No | No | |
| Results article | Efficacy results | 01/04/2022 | 08/04/2022 | Yes | No |
| Funder report results | 01/05/2022 | 11/05/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
11/05/2022: Publication reference added.
08/04/2022: Publication reference added.
09/08/2021: The following changes were made to the trial record:
1. The basic results have been uploaded as an additional file.
2. The total final enrolment was added.
14/06/2021: Publication reference added.
18/02/2021: Publication references added.
15/02/2021: Publication reference added.
22/11/2018: The recruitment end date was changed from 17/08/2018 to 28/08/2018.
06/08/2018: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/05/2019 to 30/11/2019
2. The recruitment end date was changed from 30/04/2018 to 17/08/2018
3. The intention to publish date was changed from 31/07/2019 to 31/01/2020
12/03/2018: The following changes were made to the trial record:
1. The public title was updated from "Journeying through dementia: exploring the effectiveness of a group self-management intervention for people in the early stages of dementia" to "Journeying through dementia: exploring the clinical and cost-effectiveness of a group self-management intervention for people in the early stages of dementia".
2. The contact details were updated.
3. The recruitment end date was changed from 31/12/2017 to 30/04/2018.
4. The trial participating centres were updated to remove Rotherham, Doncaster and South Humber NHS Trust and add Lincolnshire Partnership NHS Foundation Trust, Northamptonshire Healthcare NHS Foundation Trust, North Staffordshire Combined Healthcare NHS Trust, University Hospitals of North Midlands NHS Trust and Northumberland Tyne and Wear NHS Foundation Trust.
