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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dementia Awareness Course | Experimental | Participants 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dementia Awareness Course UK | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aimee Spector | UCL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London | London | WC1E 6BT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34886707 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 7, 2022 | May 22, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| 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. | 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. | 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. | 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). | Baseline and 1 month |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |