DementiaDAC-UKNCT05887063
Trialling an Online UK Dementia Awareness for Caregivers Course
A study testing Dementia Awareness Course UK in people with Dementia and Caregiver Burden, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dementia, Caregiver Burden
- What is being tested?
- Dementia Awareness Course UK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2022to 6 Dec 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Person living with dementia residing in residential care
- Professional caregiver of people living with dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Feasibility, Acceptability, and Impact of an Online UK Dementia Awareness Course for Informal Caregivers: A Mixed Methods Study
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.
Read the detailed description
All participants were given information on the study before providing informed consent. The participants were screened against eligibility criteria before being randomly allocated to either the treatment condition of attending the course, or the control condition of treatment as usual. Participants completed 5 outcome measures and a demographics questionnaire at baseline. The treatment group then attended a one-off half-day Dementia Awareness Course online, delivered by one trainee clinical psychologist. A month later, all participants completed the same 5 outcome measures and those who attended the course also attended a one-to-one half an hour online semi-structured interview.
- Conditions
- Dementia, Caregiver Burden
- Being tested
- Dementia Awareness Course UK
- Keywords
- Dementia, Caregiver, Intervention, Biopsychosocial
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia Awareness Course UKOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dementia Awareness Course | Experimental | Participants attended one half-day Dementia Awareness course as a part of a group, delivered online Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of target sample recruited within 6 months.
Feasibility of recruitment, considered feasible if full sample successfully recruited within 6 month time frame
Measured: 6 months
Percentage of participants retained at follow-up to measure feasibility of the study design.
75% considered indicative of a feasible study design
Measured: 1 month
Percentage of completion of outcome measures to measure feasibility and acceptability.
75% considered indicative of feasible and acceptable outcome measures
Measured: Baseline and 1 month
Retention and attendance percentages to measure feasibility and acceptability of the intervention.
60% considered indicative of feasible and acceptable intervention
Measured: 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
Measured: 1 month
Secondary outcomes (5)
Change from baseline in the mean Zarit burden inventory scores at one-month follow up
Exploratory outcome measure - questionnaire. The short-form Zarit burden inventory (ZBI) is a 12-item questionnaire that measures caregiver's perceived burden as a result of their role. Each item is scored from 0 (never) to 4 (nearly always) where a low score is indicative of a low sense of burden. The ZBI is one of the most commonly used measures for burden in the field and has been shown to have high levels of validity and reliability.
Measured: Baseline and 1 month
Change from baseline in the mean Quality caregiver-patient relationship (QCPR) scores at one-month follow up
Exploratory outcome measure - questionnaire. The carer version of the quality of the caregiver patient relationships (QCPR) is a 14-question survey that captures the positive and negative aspects of the caregiving relationship. The questions are scored on a 5-point Likert scale where 1 is totally disagree and 5 is totally agree. Six items are reversed scored (2, 3, 8, 10, 11, 13). A score of less than 42 is considered indicative of a poor caregiver-patient relationship, a score of 42-56 is labelled as a standard relationship, with scores of higher than 56 indicating a good relationship. Reliability and validity of the QCPR have been found to be high.
Measured: Baseline and 1 month
Change from baseline in the mean GAIN measure scores at one-month follow up
Exploratory outcome measure - questionnaire. The gain in Alzheimer's care instrument (GAIN) comprises of 10 questions that cover the possible positive aspects of a caregiving role in terms of relationship with the person living with dementia, self-reflection and personal development. Each question is scored from 0 to 5 (disagree a lot to agree a lot) where a high score suggests a high level of positive gain from caregiving. This tool has been found to be valid and reliable for use.
Measured: Baseline and 1 month
Change from baseline in the mean approaches to dementia (ADQ-19) scores at one-month follow up
Exploratory outcome measure - questionnaire. The approaches to dementia questionnaire (ADQ-19) is a 19-question survey that measures an individual's attitudes towards dementia and people living with dementia. Each question is scored on a five-point Likert scale from 0 (strongly agree) to 4 (strongly disagree). Reverse scoring is used on items 5, 7, 9, 11, 12, 15, 16, 17, 18, 19, and an overall high score indicates positive attitudes towards dementia and person living with dementia. The ADQ-19 has been shown to have good reliability (α=0.76 for hope, α=0.85 for person-centredness) and validity when compared with similar measures and qualitative observations.
Measured: Baseline and 1 month
Change from baseline in the mean short sense of competence (SSCQ) scores at one-month follow up
Exploratory outcome measure - questionnaire. The short sense of competence questionnaire (SSCQ) is a 7-item questionnaire that measures an individual's sense of competence in their role as a caregiver. Each item is scored on a five-point Likert scale from 1 to 5, where 1 is agree strongly and 5 is disagree strongly. Scores can range from 7 to 35 with higher scores indicating a greater sense of competence/satisfaction. The SSCQ has been found to have high construct validity (r=0.88) when compared to the original sense of competence questionnaire and alongside this, high reliability (α=0.76).
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start13 Jun 2022
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
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 DementiaStudies 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
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimee Spector, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887063
- Sponsor's protocol ID
- 22375.001
- Acronym
- DAC-UK
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34886707
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility, Acceptability, and Impact of an Online UK Dementia Awareness Course for Informal Caregivers: A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT05887063
- Acronym / sponsor ID
- DAC-UK / 22375.001
- Conditions
- Dementia, Caregiver Burden
- Keywords
- Dementia, Caregiver, Intervention, Biopsychosocial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 2 Jun 2023 (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.
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.
Detailed description
All participants were given information on the study before providing informed consent. The participants were screened against eligibility criteria before being randomly allocated to either the treatment condition of attending the course, or the control condition of treatment as usual. Participants completed 5 outcome measures and a demographics questionnaire at baseline. The treatment group then attended a one-off half-day Dementia Awareness Course online, delivered by one trainee clinical psychologist. A month later, all participants completed the same 5 outcome measures and those who attended the course also attended a one-to-one half an hour online semi-structured interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dementia Awareness Course | Experimental | Other: Dementia Awareness Course UKParticipants attended one half-day Dementia Awareness course as a part of a group, delivered online |
| Treatment as Usual | No intervention | –Participants did not receive any active treatment but were able to access their usual supports |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Person living with dementia residing in residential care
- Professional caregiver of people living with dementia.
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 |
|---|---|---|
| Dementia Awareness Course UKAn 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. | Other | Dementia Awareness Course |
Primary outcome
Percentage of target sample recruited within 6 months.
Time frame: 6 months
Feasibility of recruitment, considered feasible if full sample successfully recruited within 6 month time frame
Percentage of participants retained at follow-up to measure feasibility of the study design.
Time frame: 1 month
75% considered indicative of a feasible study design
Percentage of completion of outcome measures to measure feasibility and acceptability.
Time frame: Baseline and 1 month
75% considered indicative of feasible and acceptable outcome measures
Retention and attendance percentages to measure feasibility and acceptability of the intervention.
Time frame: 1 month
60% considered indicative of feasible and acceptable intervention
Qualitative acceptability of the intervention, as measured by qualitative thematic analysis of participant interviews to capture themes regarding participant experience of the course.
Time frame: 1 month
Exploratory thematic analysis
5 secondary outcomes
Change from baseline in the mean Zarit burden inventory scores at one-month follow up
Time frame: Baseline and 1 month
Change from baseline in the mean Quality caregiver-patient relationship (QCPR) scores at one-month follow up
Time frame: Baseline and 1 month
Change from baseline in the mean GAIN measure scores at one-month follow up
Time frame: Baseline and 1 month
Change from baseline in the mean approaches to dementia (ADQ-19) scores at one-month follow up
Time frame: Baseline and 1 month
Change from baseline in the mean short sense of competence (SSCQ) scores at one-month follow up
Time frame: Baseline and 1 month
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 2 Jun 2023.
- Results publication: PubMed 34886707Stoner 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.
- 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.
Aimee Spector principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia Awareness Course UK in people with Dementia and Caregiver Burden, 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 5 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 2 Jun 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?
Percentage of target sample recruited within 6 months. (time frame: 6 months). The study lists 5 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 NCT05887063, 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 2 Jun 2023.