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Journeying through dementia: exploring the clinical and cost-effectiveness of a group self-management intervention for people in the early stages of dementia

A randomised controlled trial of the clinical and cost-effectiveness of the Journeying through Dementia intervention compared to usual care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17993825
Enrollment
486
Registered
2016-10-11
Start date
2016-11-01
Completion date
Unknown
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Dementias and neurodegeneration, Primary sub-specialty: Dementia

Interventions

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 wel

Sponsors

Sheffield Health & Social Care NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Dementia related quality of life is measured using the DEMQOL questionnaire at baseline and 8 months.

Secondary

MeasureTime frame
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

Countries

England, United Kingdom

Contacts

Public ContactJessica Wright
Jessica.Wright@sheffield.ac.uk+44 (0)114 222 4304

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 28, 2026