Outcome | Description | Operationalization and unit |
---|---|---|
Feasibility of the processes and the study design that are key to the success of the main study | ||
Recruitment rate | Rate between older acute medical inpatients admitted during the study period and study participants | n participants/n inpatients [%] |
Recruitment time | Time needed to recruit 30 participants | Time [weeks] |
Refusal rate | Rate between inpatients declining to participate and eligible inpatients | n refusing inpatients/n eligible inpatients [%] |
Retention rate | Rate between study drop-outs and study participants | n drop-outs/n of participants included [%] |
Eligibility criteria | Is it obvious who meets and who does not meet the eligibility requirements? | n of unclear cases |
Are the eligibility criteria sufficient or too restrictive? | Sufficient if recruitment rate > 10% | |
Randomization | Comparability of randomized groups (blocks of 8 without stratification) | Primary clinical endpoint (de Morton Mobility Index): Assessment of statistical differences between intervention and control group at baseline (2-sided t-test) |
Feasibility of the outcome measures | ||
Safety | Number of adverse events during study assessments | Total n |
Duration | Length of time to fill out all the study forms | Time in minutes; number (rate) of assessment sessions completed within one single session |
Acceptance | Number of refused outcome measures | Total n |
Completeness | Number of missing items per outcome measure | Total n |
Interpretability | floor or ceiling effects | ≥15% of participants are not able to perform an outcome measure; ≥15% of participants score the lowest or highest score of a scale |
Resource problems that can occur during the main study | ||
Equipment | Is the equipment readily available when and where it is needed? | Number of issues with assessment equipment, such as break downs, shortage of equipment |
Center willingness and capacity | Do the clinical centers do what they committed to do? | Number of issues with workflows; number of capacity issues |
Feasibility and acceptability of the APEP intervention and adherence to the exercise protocol | ||
Amount | Frequency | n of sessions per participant; mean n of sessions per weak |
Duration | Mean duration of sessions [min] | |
Compliance | Rate of scheduled and completed sessions | N sessions completed / n sessions scheduled (%) |
Intensity | Participant’s subjective rating of perceived exertion assessed | Mean perceived exertion after each session [BORG scale score] |
(Non)compliance or adherence rate | Rate between intervention group participants who perform at least 75% of planned APEP intervention sessions and all intervention group participants | n of intervention group participants who perform at least 75% of planned APEP intervention sessions/n intervention group participants [%] |
Safety | Adverse events (moderate, or severe) caused not, probably caused, likely caused or surely caused by the intervention | Total n |
Acceptability | Motivation | Mean motivation of participant’s to perform additional physiotherapy sessions (APEP) [numeric rating scale score; 0–10 points] |
Recovery | Mean participant’s recovery prior to additional physiotherapy sessions (APEP) [numeric rating scale score; 0–10 points] | |
Costs | Delivery of APEP intervention | Costs [€] for all actually planned and delivered APEP sessions |