Table 1 Objectives of the IMPROVE feasibility trial
Primary | Secondary |
|---|---|
1. Feasibility of recruitment strategy for local health service and participants | 1. Estimates of effect size and variability to enable accurate sample size and power calculations for a definitive RCT |
2. Time necessary to recruit participants | 2. Identification of any differences across age groups and other socio-demographic factors with regards to attrition rate |
3. Acceptability of the study design and random allocation | 3. Identification of key barriers and enablers to adoption, and large-scale implementation, of the IMPROVE trial are |
4. What the most appropriate inclusion/exclusion criteria are | 4. Definition of required for economic analysis and if they can be collected reliably |
5. Estimates of compliance, satisfaction, follow- up and attrition rates | 5. The capacity of the research team to embed this study into routine practice in the Public Health Centres |
6. To determine the initial effects of the intervention, time and intervention-time interaction on inflammatory biomarkers concentrations and periodontitis status |