NCT05887063

Brief Summary

The purpose of this study is to investigate whether an online Dementia Awareness Course is feasible for delivery and acceptable to informal caregivers of people living with dementia in the UK. It will also explore the impact of the course on different caregiver outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

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 13, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

May 5, 2023

Last Update Submit

May 23, 2023

Conditions

Keywords

DementiaCaregiverInterventionBiopsychosocial

Outcome Measures

Primary Outcomes (5)

  • Percentage of target sample recruited within 6 months.

    Feasibility of recruitment, considered feasible if full sample successfully recruited within 6 month time frame

    6 months

  • Percentage of participants retained at follow-up to measure feasibility of the study design.

    75% considered indicative of a feasible study design

    1 month

  • Percentage of completion of outcome measures to measure feasibility and acceptability.

    75% considered indicative of feasible and acceptable outcome measures

    Baseline and 1 month

  • Retention and attendance percentages to measure feasibility and acceptability of the intervention.

    60% considered indicative of feasible and acceptable intervention

    1 month

  • Qualitative acceptability of the intervention, as measured by qualitative thematic analysis of participant interviews to capture themes regarding participant experience of the course.

    Exploratory thematic analysis

    1 month

Secondary Outcomes (5)

  • Change from baseline in the mean Zarit burden inventory scores at one-month follow up

    Baseline and 1 month

  • Change from baseline in the mean Quality caregiver-patient relationship (QCPR) scores at one-month follow up

    Baseline and 1 month

  • Change from baseline in the mean GAIN measure scores at one-month follow up

    Baseline and 1 month

  • Change from baseline in the mean approaches to dementia (ADQ-19) scores at one-month follow up

    Baseline and 1 month

  • Change from baseline in the mean short sense of competence (SSCQ) scores at one-month follow up

    Baseline and 1 month

Study Arms (2)

Dementia Awareness Course

EXPERIMENTAL

Participants attended one half-day Dementia Awareness course as a part of a group, delivered online

Other: Dementia Awareness Course UK

Treatment as Usual

NO INTERVENTION

Participants did not receive any active treatment but were able to access their usual supports

Interventions

An online course delivered to a small group of informal caregivers in between 3 and 4 hours. The course is made up of three modules: what is dementia, positive engagement and caring for someone with dementia. The course is delivered by one facilitator and includes teaching, discussions and activities.

Dementia Awareness Course

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identified informal caregiver of a person living with dementia in the community.
  • Residing in the U.K.
  • Ability to engage in a course delivered in English
  • Have access to an internet-connected device capable of videoconferencing (camera and microphone functioning)
  • Available to attend pre-specified dates for DAC-UK delivery.

You may not qualify if:

  • Person living with dementia residing in residential care
  • Professional caregiver of people living with dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, WC1E 6BT, United Kingdom

Location

Related Publications (1)

  • Stoner CR, Lakshminarayanan M, Mograbi DC, Vaitheswaran S, Bertrand E, Schimidt Brum P, Durgante H, Ferri CP, Mkenda S, Walker R, Dotchin C, Paddick SM, Chandra M, Krishna M, Du B, Shaji KS, Fisher E, Spector A. Development and acceptability of a brief, evidence-based Dementia Awareness for Caregivers course in low- and middle-income countries. Dementia (London). 2022 Feb;21(2):598-617. doi: 10.1177/14713012211055316. Epub 2021 Dec 9.

MeSH Terms

Conditions

DementiaCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Aimee Spector

    UCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

June 2, 2023

Study Start

June 13, 2022

Primary Completion

December 6, 2022

Study Completion

December 6, 2022

Last Updated

June 2, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations