Research objective Methods/tools used Statistical analysis used
1. Identify perceptions of PLWD and their caregivers of the causes and consequences of falls; the importance and meaning attributed to falls and falls prevention; and the provision of falls prevention information Semi-structured interviews §
Reflective journal §
Thematic analysis using grounded theory approach
2. Identify the context for the PLWD and their caregiver to understand the current level of dementia severity; function; activity level; self-efficacy; and caregiver burden. Questionnaires:
Demographic characteristics of CG and PLWD
DSRS § (CG rated for PLWD)
ADCS § (CG rated for PLWD)
CHAMPS  § (PLWD)
Icon-FES § (PLWD)
Generalised Self Efficacy Scale § (CG)
Zarit Carer Burden Interview § (CG)
Used to inform intervention phase, but not statistically analysed
3. Identify individual risk factors for falls for the PLWD, and readiness to change behaviour for these risk factors FROP-Com § (PLWD)
Readiness to change behaviour questionnaire §
Used to inform intervention phase, but not statistically analysed
4. Present options, facilitate decision making and support behaviour change to address individual risk factors Modified Ottawa decision aid Φ
Goal setting and action plans Φ
Readiness to change behaviour questionnaire Φ
Used to inform intervention phase, but not statistically analysed
5. Evaluate change in falls rate; falls risk; self-efficacy; carer burden; and engagement of the caregiver Falls calendars recording a fall event FROP-Com ∞ ♯
Generalised Self Efficacy Scale ∞ ♯ (CG)
Zarit Carer Burden Interview ∞ ♯ (CG)
Therapeutic Engagement Index Φ
Calculate rate of falls per 1000 days Analysis of change over three time points using one-way ANOVA measures for each of these measures (F; df; p)
Post-hoc pairwise comparisons between time-points (mean difference, 95% CI)  
6. Examine factors associated with readiness to change behaviour   Demographic characteristics of CG and PLWD §
DSRS §∞ ♯ (CG rated for PLWD)
ADCS §∞ ♯ (CG rated for PLWD)
Generalised Self Efficacy Scale §∞ ♯ (CG)
Zarit Carer Burden Interview §∞ ♯ (CG)
Iconographical Falls Efficacy Scale (PLWD) §∞ ♯
CHAMPS (PLWD) §∞ ♯
Readiness to change behaviour questionnaire Φ Treatment measures considered:
  • Number of strategies considered for each falls risk factor
  • Number of goals successfully met
  • Adherence to recommended strategies ∞ ♯
  • Engagement with the intervention (TEI) Φ
 
The association between baseline characteristics and initial readiness to change a falls risk factor measured using multiple logistic regression analysis (adjusted odds ratio, 95% CI)         Categorical identification of number of strategies used and goals successfully met (yes/no) (mean, 95% CI) Adherence calculated as a proportion measure, the percentage of strategies in use compared with total recommended strategies. Caregiver engagement scores are summed for each session and then across all sessions for a total score (mean, 95% CI) One-way ANOVA used to examine differences between treatment measures and readiness to change behaviour [F, df, p].   Post hoc pairwise comparisons between levels of behaviour change scale (mean difference, 95%CI) Chi square analysis for describing change in readiness from initial to final session
7. Explore change in knowledge and understanding of falls prevention; causes and consequences of falls; and the factors related to adopting falls prevention strategies for PLWD and their caregivers Semi-structured interview at 6 months ∞
Survey at 12 months ♯
Falls calendar notes Φ
Reflective journal Φ
Case notes, goal setting and action plans recorded at each home visit Φ
Thematic analysis of 6-month interview data, falls calendar notes, case notes, reflective journal and 12-month survey data
8. Facilitate community care staff to identify their knowledge and implement falls prevention best practice for PLWD and their caregivers Knowledge survey
Action research process (audio-taped and notes taken)
Development of a discussion/decision aid
Thematic analysis of notes fed back into action research cycle, utilising principles of the Consolidated Framework for Implementation Research (see Trial Status section for more detail)
Table 4: Linking data analysis to research objectives and methods/tools used.