Better Living With Non-memory-led Dementia

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Better living with non-memory led dementia course

About this trial

This is an interventional treatment trial for Primary Progressive Aphasia focused on measuring "Posterior Cortical Atrophy"

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Treatment as usual (TAU)

Arm Description

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.

The "treatment as usual" group does not receive access to the educational programme.

Outcomes

Primary Outcome Measures

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).

Acceptability

Prospective and retrospective acceptability (e.g., reasons for not taking part, task completion rate after every module)

Secondary Outcome Measures

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.

Generalized Anxiety Disorder scale (GAD-7)

Generalized Anxiety Disorder scale (ranging from 0 (minimun) to 21 (maximun) scores). Higher scores indicates higher anxiety.

Patient Health Questionnaire (PHQ-9)

Assesses depression severity (ranging from 0 (minimun) to 27 (maximun) scores. Higher scores indicate higher depression.

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.

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.

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.

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.

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.

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.

Questions about perceived burden and ethicality

Tailored questions administered in a purposed-built interview. They

Health economics questions

Tailored questions administered in a purposed-built interview.

Full Information

NCT ID

NCT05525377

First Posted

August 12, 2022

Last Updated

April 26, 2023

Sponsor

University College, London

1. Study Identification

Unique Protocol Identification Number

NCT05525377

Brief Title

Better Living With Non-memory-led Dementia

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

June 21, 2022 (Actual)

Primary Completion Date

February 9, 2023 (Actual)

Study Completion Date

February 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Progressive Aphasia, Frontotemporal Dementia, Alzheimer Disease

Keywords

"Posterior Cortical Atrophy"

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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.

Arm Title

Treatment as usual (TAU)

Arm Type

No Intervention

Arm Description

The "treatment as usual" group does not receive access to the educational programme.

Intervention Type

Behavioral

Intervention Name(s)

Better living with non-memory led dementia course

Intervention Description

Caregivers online training and educational phenotype-specific programme on how to support people with non-memory-led dementia.

Primary Outcome Measure Information:

Title

Study feasibility

Description

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).

Time Frame

Since June 2022 to January 2023 (8 months)

Title

Acceptability

Description

Prospective and retrospective acceptability (e.g., reasons for not taking part, task completion rate after every module)

Time Frame

Since June 2022 to January 2023 (8 months)

Secondary Outcome Measure Information:

Title

WHO 5 Wellbeing Index

Description

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.

Time Frame