Better Living With Non-memory-led Dementia

Alzheimer Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05525377
• Other study ID #: RDSImpact_ws4feasibility
• Status: Completed
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: February 9, 2023

Study information

• Verified date: August 2022
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia
• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain
• Primary Progressive Aphasia

Intervention

Behavioral:
• Better living with non-memory led dementia course
Caregivers online training and educational phenotype-specific programme on how to support people with non-memory-led dementia.

Locations

Country	Name	City	State
United Kingdom	University College London	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Health economics questions	Tailored questions administered in a purposed-built interview.	At 8 weeks post-randomisation and 3 month follow up