Primary Progressive AphasiaNCT05525377
Better Living With Non-memory-led Dementia
A study testing Better living with non-memory led dementia course in people with Primary Progressive Aphasia and Frontotemporal Dementia, run by University College, London at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Progressive Aphasia, Frontotemporal Dementia, Alzheimer Disease
- What is being tested?
- Better living with non-memory led dementia course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jun 2022to 9 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- . 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).
Who cannot join
- . Those unable to comprehend written English
- . Those with no access to the internet
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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.
- Being tested
- Better living with non-memory led dementia course
- Keywords
- "Posterior Cortical Atrophy"
- Medical subject headings
- Aphasia, Primary Progressive, Frontotemporal Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Better living with non-memory led dementia courseBehavioural
Caregivers online training and educational phenotype-specific programme on how to support people with non-memory-led dementia.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Better living with non-memory led dementia course |
| Treatment as usual (TAU) | No intervention | The "treatment as usual" group does not receive access to the educational programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: Since June 2022 to January 2023 (8 months)
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 8 weeks and 3 months
Questions about perceived burden and ethicality
Tailored questions administered in a purposed-built interview. They
Measured: At 8 weeks post-randomisation and 3 month follow up
Health economics questions
Tailored questions administered in a purposed-built interview.
Measured: At 8 weeks post-randomisation and 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start21 Jun 2022
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Progressive AphasiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525377
- Sponsor's protocol ID
- RDSImpact_ws4feasibility
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suarez-Gonzalez A, John A, Brotherhood E, Camic PM, McKee-Jackson R, Melville M, Sullivan MP, Tudor-Edwards R, Windle G, Crutch S, Hoare Z, Stott J; Rare Dementia Support Impact team. "Better Living with Non-memory-led Dementia": protocol for a feasibility randomised controlled trial of a web-based caregiver educational programme. Pilot Feasibility Stud. 2023 Oct 11;9(1):172. doi: 10.1186/s40814-023-01403-1.
PubMed 37821924
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05525377
- Acronym / sponsor ID
- RDSImpact_ws4feasibility
- Keywords
- "Posterior Cortical Atrophy"
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Better living with non-memory led dementia courseSubjects 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. |
| Treatment as usual (TAU) | No intervention | –The "treatment as usual" group does not receive access to the educational programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- . 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).
Key exclusion criteria (2 listed)
- . Those unable to comprehend written English
- . Those with no access to the internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Better living with non-memory led dementia courseCaregivers online training and educational phenotype-specific programme on how to support people with non-memory-led dementia. | Behavioural | Intervention |
Primary outcome
Study feasibility
Time frame: 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
Time frame: 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)
11 secondary outcomes
WHO 5 Wellbeing Index
Time frame: Change from baseline to 8 weeks and 3 months
Generalized Anxiety Disorder scale (GAD-7)
Time frame: Change from baseline to 8 weeks and 3 months
Patient Health Questionnaire (PHQ-9)
Time frame: Change from baseline to 8 weeks and 3 months
De Jong Gierveld Loneliness Scale
Time frame: Change from baseline to 8 weeks and 3 months
Lubben Social Network Scale
Time frame: Change from baseline to 8 weeks and 3 months
Pearling Mastery Scale
Time frame: Change from baseline to 8 weeks and 3 months
Caregiver self-efficacy scale
Time frame: Change from baseline to 8 weeks and 3 months
Dementia Management Strategies Scale
Time frame: Change from baseline to 8 weeks and 3 months
The quality of carer-partner relationship scale
Time frame: Change from baseline to 8 weeks and 3 months
Questions about perceived burden and ethicality
Time frame: At 8 weeks post-randomisation and 3 month follow up
Health economics questions
Time frame: At 8 weeks post-randomisation and 3 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Derived from this study: PubMed 37821924Suarez-Gonzalez A, John A, Brotherhood E, Camic PM, McKee-Jackson R, Melville M, Sullivan MP, Tudor-Edwards R, Windle G, Crutch S, Hoare Z, Stott J; Rare Dementia Support Impact team. "Better Living with Non-memory-led Dementia": protocol for a feasibility randomised controlled trial of a web-based caregiver educational programme. Pilot Feasibility Stud. 2023 Oct 11;9(1):172. doi: 10.1186/s40814-023-01403-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Better living with non-memory led dementia course in people with Primary Progressive Aphasia and Frontotemporal Dementia, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study feasibility (time frame: Since June 2022 to January 2023 (8 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05525377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.