I25
Conditions
Interventions
Group 1: Patients receive, in addition to standard medical care (SOC), an additional psychological expectation-optimizing online intervention (iEXPECT) with personalized feedback via phone calls (iEXP
Sponsors
Philipps-Universität Marburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Medical necessity to perform a CABG (without valve), elective surgery, median sternotomy, with/without ECC, sufficient knowledge of the German language, Adequate cognitive fitness to give consent to participate in the study, Valid email address, Regular access to a computer with an internet connection, Consent at least 5 to 21 days before the surgery.
Exclusion criteria
Exclusion criteria: Emergency surgery, minimally invasive surgical procedure, presence of another (non-cardiac) life-threatening condition, comorbid medical/psychiatric condition causing at least a similar impairment compared to coronary and valvular heart disease, participation in other interventional/experimental research programs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and Acceptance of a Guided Preoperative Internet-Based Expectation Manipulation Intervention (iEXPECT). This will be assessed using 3 criteria: 1) The feasibility of the study design is assumed if at least one subject per week per center can be recruited (approximately 160 subjects from three centers over 53 weeks) and >49% of all randomized patients provide complete data for the 6-month follow-up examinations (including biomarkers). The proportion of patients with complete data for the 6-month follow-up assessments (including biomarkers) will be reported as a point estimate per group. Two-sided 95% confidence intervals will be given. 2) Feasibility of the internet-based intervention is assumed if >75% of the randomized patients in each iEXPECT arm complete at least 1 (>0) online module before the surgery. The completion rate will be reported as a point estimate per intervention group, and two-sided 95% confidence intervals will be provided. To assess whether time to surgery influences outcome criterion 2 (completion of at least one online module before surgery), a sensitivity analysis will be considered. 3) Acceptance of the Internet intervention is assumed if the average rating of the patients for overall acceptance/satisfaction is positive (for the ratings, an average value is calculated after the completion of each of the 4 modules; >3.4 on a 5-point Likert scale) and via a standardized satisfaction questionnaire (CSQ-I, 2 measurement points: after intervention/pre-surgery, 6 months post-surgery). Each intervention group will be analyzed separately. | — |
Secondary
| Measure | Time frame |
|---|---|
| Descriptive evaluations per group will be conducted for the respective secondary outcome variables: - Illness-related disability (4 measurement points: Baseline, after intervention/pre-surgery, post-surgery, 6 months post-surgery; Questionnaire: PDI - adapted version) - Expectations and prior experiences (4 measurement points: Baseline, after intervention/pre-surgery, post-surgery, 6 months post-surgery; Questionnaire: G-EEE and TEX-Q) - Subjective illness representations (4 measurement points: Baseline, after intervention/pre-surgery, post-surgery, 6 months post-surgery; Questionnaire: B-IPQ) - Health-related quality of life (4 measurement points: Baseline, after intervention/pre-surgery, post-surgery, 6 months post-surgery, Questionnaire: SF-12) - Preoperative anxiety (2 measurement points: Baseline, after intervention/pre-surgery; Questionnaire: APAIS) - Anxiety and depression (4 measurement points: Baseline, after intervention/pre-surgery, post-surgery, 6 months post-surgery; Questionnaire: PHQ-9 and GAD-7) - Physical activity (4 measurement points: Baseline, after intervention/pre-surgery, post-surgery, 6 months post-surgery; Questionnaire: IPAQ) - Optimism (4 measurement points: Baseline, after intervention/pre-surgery, post-surgery, 6 months post-surgery; Questionnaire: LOT-R) - Pain (4 measurement points: Baseline, after intervention/pre-surgery, post-surgery, 6 months post-surgery; Questionnaire: VAS) - Perceived stress (4 measurement points: Baseline, after intervention/pre-surgery, post-surgery, 6 months post-surgery; Questionnaire: PSS) - Beliefs about online interventions and Digital Health Literacy (1 measurement point: Baseline; Questionnaire: APOI and GR-eHEALS) - Side effects (1 measurement point: after intervention/pre-surgery; Questionnaire: NEQ) - Social support (2 measurement points: Baseline, after intervention/pre-surgery; Questionnaire: ESSI) - Rehospitalization (2 measurement points: post-surgery, 6 months post-surgery; Intervi | — |
Countries
Germany
Contacts
Public ContactStefan Salzmann
Klinische Psychologie und Psychotherapie, Philipps-Universität Marburg
Outcome results
None listed