Better Living With Non-memory-led Dementia

Not Applicable

Completed

• Conditions: Frontotemporal Dementia; Primary Progressive Aphasia; Alzheimer Disease
• Interventions: Behavioral: Better living with non-memory led dementia course

• Registration Number: NCT05525377
• Lead Sponsor: University College, London

Brief Summary

This is a feasibility study on the effects of an online-based training and education programme for carers of people with posterior cortical atrophy (PCA), primary progressive aphasia (PPA) and behavioural-variant frontotemporal dementia (bvFTD).

Detailed Description

The purpose of this study is:

To evaluate the feasibility of an online training course for carers of people with PCA, PPA, and bvFTD. Feasibility measures will focus on the recruitment process and measurement tools.

To determine the acceptability of an online training course for carers of people with PCA, PPA and bvFTD.

The study will involve 6 online modules over the course of 7 weeks. All sessions will take place over the internet, using an online platform. A research team member (facilitator) will be available to assist participants over the course completion.

Study Timeline

• Study Start: 2022-06-21
• Status Verified: 2022-08
• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-09-01
• Primary Completion: 2023-02-09
• Study Completion: 2023-02-09
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. . Adults (18+) who self-identify as an unpaid carer (partners, children, friends, etc.) of someone with PPA, PCA or bvFTD who is not living in a full-time care facility.
2. . The care recipient has to have a confirmed diagnosis of dementia (through self-report of the carer, to reflect the 'real world' application of the intervention).

Exclusion Criteria

1. . Those unable to comprehend written English
2. . Those with no access to the internet

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Better living with non-memory led dementia course	Subjects in the intervention group receive access to an online training and educational phenotype-specific programme on how to support their relative with non-memory-led dementia. The online course consists on 6 modules to complete in 7 weeks. A course facilitator is available throughout the duration of the intervention to support participants.

Primary Outcome Measures

Name	Time	Method
Study feasibility	Since June 2022 to January 2023 (8 months)	Feasibility of recruitment process and measurement tools (e.g., number of people agreeing to be sent information about the study, time taken to fill in questionnaires).
Acceptability	Since June 2022 to January 2023 (8 months)	Prospective and retrospective acceptability (e.g., reasons for not taking part, task completion rate after every module)

Secondary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder scale (GAD-7)	Change from baseline to 8 weeks and 3 months	Generalized Anxiety Disorder scale (ranging from 0 (minimun) to 21 (maximun) scores). Higher scores indicates higher anxiety.
Pearling Mastery Scale	Change from baseline to 8 weeks and 3 months	Measures the extent to which an individual regards their life chances as being under their personal control. Ranging from 7 (minimun) to 28 (maximun) scores. Higher scores indicate greater levels of mastery.
Patient Health Questionnaire (PHQ-9)	Change from baseline to 8 weeks and 3 months	Assesses depression severity (ranging from 0 (minimun) to 27 (maximun) scores. Higher scores indicate higher depression.
Dementia Management Strategies Scale	Change from baseline to 8 weeks and 3 months	Instrument to appraise 3 care styles of caregivers: 1) Active management, 2) Criticism and 3) Encouragement. Ranging from 34 (minimun) to 170 (maximun). Higher scores mean a greater presence of behaviours associated to the the corresponding caregiver style.
WHO 5 Wellbeing Index	Change from baseline to 8 weeks and 3 months	Short self-reported measure of current mental wellbeing (ranging from 0 (minimun) to 25 (maximun) scores). 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
De Jong Gierveld Loneliness Scale	Change from baseline to 8 weeks and 3 months	Measure variations in total loneliness score ranging from 0 (minimun) to 11 (maximun) scores. 0 meaning not lonely and 100 very severe lonely score.
Questions about perceived burden and ethicality	At 8 weeks post-randomisation and 3 month follow up	Tailored questions administered in a purposed-built interview. They
Lubben Social Network Scale	Change from baseline to 8 weeks and 3 months	Brief instrument designed to gauge social isolation in older adults by measuring perceived social support received by family and friends. Ranging from 0 (minimun) to 60 (maximun) scores. Higher scores represent higher social network.
Caregiver self-efficacy scale	Change from baseline to 8 weeks and 3 months	Measures caregivers' beliefs about their ability to carry out behaviors such as obtaining respite, responding to disruptive patient behaviors, etc. Ranging from 0 (minimun) to 100 (maximun) scores. Higher scores reflect higher confidence.
The quality of carer-partner relationship scale	Change from baseline to 8 weeks and 3 months	Scale that measures closeness in a relationship. Ranging from 14 (minimun) to 70 (maximun). Higher scores reflect higher quality of carer-partner relationship.
Health economics questions	At 8 weeks post-randomisation and 3 month follow up	Tailored questions administered in a purposed-built interview.

Trial Locations

Locations (1)

University College London; 🇬🇧 London, United Kingdom