Better Living With Non-memory-led Dementia

Study Overview
=================
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.

Official Title
-----------------
Better Living With Non-memory-led Dementia: Feasibility Study on the Effects of a Blended Online Training Course for Carers of People With Atypical AD and FTD.

Conditions
-----------------
Primary Progressive Aphasia, Frontotemporal Dementia, Alzheimer Disease

Intervention / Treatment
-----------------
* Behavioral: Better living with non-memory led dementia course


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: . 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. . 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: . Those unable to comprehend written English . Those with no access to the internet

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Better living with non-memory led dementia course<br>* Caregivers online training and educational phenotype-specific programme on how to support people with non-memory-led dementia.<br>|
| No Intervention: Treatment as usual (TAU)<br>The treatment as usual group does not receive access to the educational programme. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study feasibility | 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). | Since June 2022 to January 2023 (8 months) | 
| Acceptability | Prospective and retrospective acceptability (e.g., reasons for not taking part, task completion rate after every module) | Since June 2022 to January 2023 (8 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO 5 Wellbeing Index | 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. | Change from baseline to 8 weeks and 3 months | 
| Generalized Anxiety Disorder scale (GAD-7) | Generalized Anxiety Disorder scale (ranging from 0 (minimun) to 21 (maximun) scores). Higher scores indicates higher anxiety. | Change from baseline to 8 weeks and 3 months | 
| Patient Health Questionnaire (PHQ-9) | Assesses depression severity (ranging from 0 (minimun) to 27 (maximun) scores. Higher scores indicate higher depression. | Change from baseline to 8 weeks and 3 months | 
| De Jong Gierveld Loneliness Scale | Measure variations in total loneliness score ranging from 0 (minimun) to 11 (maximun) scores. 0 meaning not lonely and 100 very severe lonely score. | Change from baseline to 8 weeks and 3 months | 
| Lubben Social Network Scale | 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. | Change from baseline to 8 weeks and 3 months | 
| Pearling Mastery Scale | 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. | Change from baseline to 8 weeks and 3 months | 
| Caregiver self-efficacy scale | 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. | Change from baseline to 8 weeks and 3 months | 
| Dementia Management Strategies Scale | 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. | Change from baseline to 8 weeks and 3 months | 
| The quality of carer-partner relationship scale | Scale that measures closeness in a relationship. Ranging from 14 (minimun) to 70 (maximun). Higher scores reflect higher quality of carer-partner relationship. | Change from baseline to 8 weeks and 3 months | 
| Questions about perceived burden and ethicality | Tailored questions administered in a purposed-built interview. They | At 8 weeks post-randomisation and 3 month follow up | 
| Health economics questions | Tailored questions administered in a purposed-built interview. | At 8 weeks post-randomisation and 3 month follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Posterior Cortical Atrophy