MacEntee 2007.
Methods | Cluster‐randomised controlled trial, 2 arms Study period: not reported Planned follow‐up: 3 months |
|
Participants | Country: Canada Setting: 14 long‐term care facilities Target audience for intervention: care‐aides Number of randomised participants (nursing home residents with intermediate care): 127 Number of analysed participants (nursing home residents with intermediate care): 113 Age, mean, years: 78.3 in IG, 79.9 in CG Female: not reported Edentulous: excluded Residents with dental prosthesis: not reported Inclusion criteria: residents receiving intermediate care, with natural teeth, and cognitively and physically suitable for a clinical examination of the mouth Exclusion criteria: not explicitly stated |
|
Interventions |
Intervention group Pyramidal education consisting of the following. Education/skills training:
Information material:
Additional components:
Control group Usual routine (comprises the same 1‐hour seminar with photographs, texts, and demonstrations but delivered directly to the care‐aides by the dental hygienist. No additional information or support.) Co‐interventions n/a |
|
Outcomes |
Primary outcomes Oral hygiene measures were assessed at baseline and 3 months after the seminar.
Secondary outcomes Clinical measures of dietary nourishment and masticatory potential were assessed at baseline and 3 months after the seminar.
Additional outcomes: psychosocial outcomes were assessed using qualitative research methods (questionnaires, interviews). |
|
Funding | BC Medical Service Foundation Grant | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomised block design"; correspondence: "generated from a programme by a research assistant" |
Allocation concealment (selection bias) | Low risk | Quote: "A person not involved in the education or analysis of results performed the random selections and assignments, and broke the code when all data were collected." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind.... Neither the examiner nor the residents knew the intervention assignments." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The examiner or assistant did not know the educational method assigned to the facilities, nor did they know the results from the baseline examinations when examining the residents 3 months later." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Data for outcomes (gingival bleeding score, tab. 3) were not collected from all participants due to some participants being unable or unwilling to co‐operate fully. Losses to follow‐up comparable in intervention (N = 8) and control group (N = 6). |
Selective reporting (reporting bias) | Low risk | Insufficient information in published study report, additional data provided on request. Results of the psychosocial aspects not published/not available. |
Other bias | Unclear risk | Possible recruitment bias (insufficient information) |