Outcome variable | Label of instrument | Description of instrument Type of instrument Sub-concept/-variable Items/scales/assessment | Time of measurement; group | Scale calculation/cut-off points |
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Demographic and clinical characteristics of participants | Q1 | Self-reported questionnaire Demographic data (4 items) ▪ Age (in years) ▪ Sex ▪ Housing situation (living alone; with another person) ▪ Highest educational qualification Clinical characteristics (4 items) ▪ Years of diagnosis of AF (in years) ▪ Experience in pulse self-palpation (yes, no) ▪ Presence of an electronic device for pulse measurement at home (yes, no) ▪ Regular implementation of pulse self-measurement at home (no, yes [multiple times a day; once per day; not daily, but multiple times per week; not every week, but multiple times per month; not every month, but multiple times per year]) | T1; IG and UCG | |
Acceptability of intervention | Q2.A.I | Self-reported questionnaire Assessment of appropriateness of the intervention (7 items) ▪ Usefulness of intervention (5-point Likert-scale, very useful–not useful) ▪ Importance of learning PSP when suffering arrhythmias (5-point Likert-scale, very important–not important) ▪ Liking of intervention (5-point Likert-scale, very much–not at all) ▪ Would participants recommend the intervention to others (yes, no) ▪ Appraisal of duration of intervention (too short, accurate, too long) ▪ Appraisal of difficulty level of intervention (5-point Likert-scale, very easy–very difficult) ▪ Appraisal of comprehensibility of content of intervention (5-point Likert-scale, very easy to understand–very difficult to understand) | T1 (directly after intervention); IG | The PSPAF intervention was considered acceptable to intervention participants when: − ≥ 75% will rate the intervention partly to very reasonable − ≥ 75% will rate the intervention partly to very important − ≥ 75% will like the intervention partly to very much − ≥ 75% will eventually or definitively recommend the intervention to others − ≥ 75% will rate the duration of the intervention as accurate − ≥ 75% will rate the difficulty level of the intervention partly to very easy − ≥ 75% will rate the comprehensibility of the intervention as partly to very high − ≥ 75% will rate the intervention partly to very helpful − ≥ 90% did not experience any negative consequences related to the intervention − ≥ 75% will rate implementation of the content of the intervention in daily life partly to very easy − ≥ 75% will rate the likelihood of continuing a daily PSP twice a day as likely to very likely − ≥ 75% will be considered adherent to PSP (> 80% of possible entries are filled out) |
Q2.A.II | Self-reported questionnaire Assessment of perceived effectiveness (1 item) ▪ Extent of how helpful the intervention was concerning dealing with AF in everyday life (5-point Likert-scale, very helpful–not helpful) Assessment of perceived disadvantages (1 item) ▪ Negative consequences of intervention (yes, no, do not know) Assessment of perceived suitability (1 item) ▪ Difficulty level of implementation of the content of the intervention in everyday life (5-point Likert-scale, very easy–very difficult) Assessment of willingness of implementation (1 item) ▪ Likelihood of continuing a PSP twice a day (5-point Likert-scale, very likely–very unlikely) | T2; IG | ||
D1 | Pulse diary Assessment of adherence to PSP Booklet consisting of a table with 35 lines and 10 columns. Each line represents a day and has two fields for indications of time of day, heart rate and regularity or irregularity of the measured pulse, respectively. A total of 70 pulse measurements could be recorded. An additional field was implemented for any specifics or further measurements. | T1-T2; IG | ||
Feasibility of the intervention | F2 | Field note form Context/resources Boxes assessing date, location, the existence of enough suitable rooms for delivering the intervention, and the presence of relatives during the delivery of the intervention | T1 (directly after intervention); IG | The PSPAF intervention was considered feasible when: − The intervention can be delivered within 30 min, − Fidelity to the intervention protocol will maintain at 85% − Appropriate and enough room will exist in ≥ 85% of sessions |
Audio recording | Audio recordings of intervention sessions Fidelity of intervention implementation (3 items) ▪ Rating of clarity, distinctness, and comprehensiveness of language, and verbalizations of interventionist (each item, 4-point rating scale; not at all (0 points)–completely (3 points); single weighting) ▪ Rating whether the whole content and all components have been delivered as listed in the intervention manual (4-point rating scale, not at all (0 points)–completely (3 points), threefold weighting) ▪ Rating whether the whole content and all components have been delivered in the correct order as listed in the intervention manual (4-point rating scale, not at all (0 points)–completely (3 points), threefold weighting) Time needed for delivering the intervention ▪ Assessed by the length of audio recordings (minutes, seconds) | T1; IG | ||
Feasibility of research methods | F1 | Field note form (set up for every screening session) Process of recruitment (7 criteria) ▪ Date ▪ Location ▪ Amount of screened individuals ▪ Amount of eligible individuals ▪ Amount of excluded individuals ▪ Amount of included individuals Reasons for refusal ▪ Free text (indication was voluntary) | Stage of screening;Study coordinator | Research methods was considered feasible when: − Recruitment of the target number of participants (n = 20) was accomplished within 4 months of beginning the study − ≥ 80% of intervention participants attended the follow-up session (home visit) − Attrition will be ≤ 15% − ≥ 80% of data sets were completed − Treatment contamination occurred in ≤15% − ≥90% of participants perceived no or low burden of study participation |
C0 | Checklist Process of recruitment and documentation of eligibility criteria Assessment of occurrence of each in- and exclusion criterion for every screened individual | Stage of screening; Study coordinator | ||
F3 | Field note form Resources and management (5 criteria) ▪ Date ▪ Number of homes visits (on that day) ▪ Amount of driven kilometers (on that day) ▪ Amount of time (minutes) required for home visits and travel routes (on that day) ▪ Specifics (free text) | T2; IG and UCG study assistant | ||
Q2.C | Self-reported questionnaire Assessment of treatment contamination (3 items) ▪ Participation in a training to learn PSP 3–4 weeks since inclusion in study (yes, no, do not know) ▪ Reading or watching media reports containing a training to learn PSP 3–4 weeks since inclusion in study (yes, no, do not know) ▪ Advice or training to learn PSP through family physician 3–4 weeks since inclusion in study (yes, no, do not know) | T2; UCG | ||
Burden of study participation | Q2.B | Self-reported questionnaire Burden of study participation (1 item) ▪ Grading the statement “I felt burdened by participating in this study.” (5-point Likert-scale, totally agree–totally disagree, translated into very high–no burden) Subscale: if burden was perceived ➔ specification of kind of burden (3 items): psychological and/or physiological and/or financial burden | T2; IG and UCG | |
Capability of PSP | C1 | Checklist (for structured observation by study assistant) Structure (2 items) ▪ PSP in rest (correct, wrong) ▪ Use of a clock with second hand (correct, wrong) Process (5 items) ▪ Location of measurement (correct, wrong) ▪ Technique of measurement (correct, wrong) ▪ Duration of the measurement (correct, wrong) ▪ Stating determined value of the heart rate (no, yes [value in bpm]) ▪ Stating determined value of the heart rhythm (no, yes [rhythmic, arrhythmic]) Outcome (2 items) ▪ Comparison of heart rate determined by the participant and heart rate determined by mobile ECG device (bpm) [verification of the value after consultation with a physician] (correct, wrong—heart rate was considered correct if heart rate measured by participants was ± 8 bpm in comparison to the ECG) ▪ Comparison of heart rhythm determined by the participant and heart rhythm determined by mobile ECG device [ECG evaluation by a physician, rhythmic/arrhythmic] (correct, wrong—heart rhythm was considered correct if the measurement of participants was equal to the evaluation of a physician) | T2; IG and UCG | A participant is seen as capable of PSP if all 9 components are correct or fulfilled, respectively. |
Mobile ECG device ME 90; Beurer GmbH, Ulm | T2; IG and UCG | |||
Sign and symptom management | V1-3/Vs1-3 | Vignettes (in written form) V1—physiologic values, V2—mild pathologic values, V3— severe pathologic values Sign and symptom management was rated “correct” or “wrong” by a study assistant by means of a standard solution for each vignette (Vs1-3). | T2; IG and UCG | Participants were considered being able to manage signs and symptoms if they solved the vignette correctly. |