Table 1. Summary of the key study objectives, outcomes and analysis plans.
Aim | Objectives | Outcome | Criterion for Feasibility | Statistical Analysis |
---|---|---|---|---|
Primary | Assess feasibility of
recruitment, retention, group size and data completion. |
Recruitment and retention
rates, missing data. |
Music and Movement for Health is feasible.
The rate of participants recruited to the study, retention rate (the number of participants who complete measures at baseline and at follow up post intervention, minimum average attendance (number of participants who attended at least 65% of the intervention sessions). We will calculate the minimum outcome assessment target, as a retention rate of at least 80% of recruited participants with valid baseline and 12-week primary outcome data. |
To assess if we can recruit and retain
sufficient eligible older adults to inform a future definitive trial. Descriptive statistics: mean and SD for continuous variables proportions for dichotomous variables. |
Assess safety of the programme. | Safety: adverse effects e.g.,
falls, a weekly falls log will be completed. |
The programme is safe.
There is no increase in direct adverse events due to the intervention (e.g., falls during the intervention period). |
Safety assessed through self-report of
direct or unrelated adverse events (e.g., falls or pain during the programme period). |
|
To obtain participants’ & stakeholder
feedback and experiences of the study processes and programme. |
Qualitative study feedback. |
Music and Movement for Health is acceptable.
The majority of participants report that the study processes including measures were feasible and acceptable. |
Thematic analysis. Data regarding
combined completion and acceptability of measures. |
|
Objective | Outcomes | Hypothesis | Statistical Analysis | |
Secondary | To explore the differences between
the groups for Physical Function, Balance, Physical Activity, Loneliness, Social Isolation, Mood, and Quality of Life. |
Results for Clinical outcomes:
Physical Function, Balance, Physical Activity, Loneliness, Social Isolation, Mood, and Quality of Life. |
The programme
group will show improvement in scales. |
Regression analysis |
To explore the differences between
the groups for Physical Function, Balance, Physical Activity, Loneliness, Social Isolation, Mood, and Quality of Life. |
Results for each outcome of
interest. |
We can determine the required sample size for a
definitive trial. |
ICC (intraclass correlation coefficient)
will be used to calculate the design effect. Thus, the required sample size for a CRCT (cluster-randomised controlled trail) will be calculated by multiplying the required sample size for the equivalent ungrouped study with the DE. |
|
Pilot economic analysis to assess
costs and inform a definitive trial. |
A pilot economic analysis
to inform the design and conduct of a full economic evaluation to assess the cost effectiveness of the programme developed. |
The methods developed and implemented for
the conduct of the pilot health economic analysis proved to be feasible and acceptable to study participants. |
The criterion for success includes
obtaining sufficient data on cost. Incremental analysis to calculate the mean differential in costs and QALYs. The incremental cost effectiveness ratio (ICER) will be calculated and analysed. Parametric and probabilistic analyses will be employed to explore uncertainty. |