NCT05525377

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2023

Completed
Last Updated

April 27, 2023

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

August 12, 2022

Last Update Submit

April 26, 2023

Conditions

Primary Progressive AphasiaFrontotemporal DementiaAlzheimer Disease

Keywords

"Posterior Cortical Atrophy"

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (11)

  • WHO 5 Wellbeing Index

    Change from baseline to 8 weeks and 3 months

  • Generalized Anxiety Disorder scale (GAD-7)

    Change from baseline to 8 weeks and 3 months

  • Patient Health Questionnaire (PHQ-9)

    Change from baseline to 8 weeks and 3 months

  • De Jong Gierveld Loneliness Scale

    Change from baseline to 8 weeks and 3 months

  • Lubben Social Network Scale

    Change from baseline to 8 weeks and 3 months

  • +6 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

Better living with non-memory led dementia courseBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Those unable to comprehend written English
  • Those with no access to the internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, WC1N 3BG, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 37821924DERIVED

MeSH Terms

Conditions

Aphasia, Primary ProgressiveFrontotemporal DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAphasiaSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersFrontotemporal Lobar DegenerationTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesTauopathies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2022

First Posted

September 1, 2022

Study Start

June 21, 2022

Primary Completion

February 9, 2023

Study Completion

February 9, 2023

Last Updated

April 27, 2023

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)