Better Living With Non-memory-led Dementia

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.

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).

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Frontotemporal Dementia; Primary Progressive Aphasia
• Intervention / Treatment: Behavioral: Better living with non-memory led dementia course

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 3BG
    • University College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Caregivers online training and educational phenotype-specific programme on how to support people with non-memory-led dementia.
No Intervention: Treatment as usual (TAU); 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

Collaborators and Investigators

• Sponsor: University College, London

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Actual): February 9, 2023
• Study Completion (Actual): February 9, 2023

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: "Posterior Cortical Atrophy"
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Tauopathies; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Dementia; Alzheimer Disease; Aphasia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: RDSImpact_ws4feasibility

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No