Chapter 6 120 and determined group medians for both the intervention and control groups. Wilcoxon rank-sum and Mann-Whitney U tests were used to assess within- and between-group differences, respectively. Rank correlation tests examined the relationship between changes in CGQ scores and factors such as age, education level, initial CGQ scores, and waiting period length. Fisher’s exact test was used to analyze differences in dropout rates. For the qualitative data, we performed a thematic analysis (Braun & Clarke, 2006) using ATLAS.ti (Version 9.1.3, ATLAS.ti Scientific Software Development GmbH). Interviews were transcribed verbatim, followed by coding individual quotations and corresponding interpretations. These codes were then grouped into overarching themes related to the outcome measures, such as adherence, acceptance, and impact on feelings of certainty and guidance. 6.2.7 Ethics and data management This study adhered to the Declaration of Helsinki principles and was approved by the Medical Ethics Committee of Erasmus MC (MEC-2022-0483) and registered in clinicaltrials.gov (NCT05698121). Written informed consent was obtained from all study participants. 6.3 Results 6.3.1 Participants Out of the 835 patients referred to the CR center during the recruitment period (January 2023 to June 2023), 149 patients (18%) were eligible, of which 42 patients (28%) consented to participate. Frequently reported reasons for non-participation were personal circumstances, logistical issues, lack of interest, technological barriers, and language and cognitive barriers. Twenty-one participants were assigned to the intervention group and 21 to the control group (see Figure 6.3). One participant in the control group dropped out during the study due to the burden of participation. Eighteen participants from the intervention group participated in a semi-structured interview and 19 participants from the intervention group sent their usage data for the adherence analysis. The majority of the sample was male (80%), with a median (IQR) age of 62 (14) years. Ischemic heart disease was the most common condition (63%). The median (IQR) waiting time from hospital discharge to the start of CR was 55 (43) days and 29 (13) days from enrollment at the CR facility to the beginning of the program. See Table 6.2 for more details.
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