iHEART trial: study protocol for a German multicentre randomised controlled trial on the feasibility and acceptance of an internet-based preoperative intervention to optimise patient expectations and improve outcomes after heart surgery
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Date
Publisher
BMJ
Abstract
Introduction: Treatment expectations are a key
mechanism of placebo effects in clinical trials. In a
previous study (PSY-HEART-
I),
preoperative expectation
optimisation improved quality of life 6 months postcardiac
surgery. However, barriers such as travel distance, staffing
shortages and COVID-19
limited participation. This study
evaluates the feasibility and acceptability of iEXPECT, a
brief internet-based
intervention designed to optimise
expectations before heart surgery.
Methods and analysis: In this three-arm,
multicentre
randomised controlled trial, 160 patients undergoing
elective coronary artery bypass graft surgery are
randomised to: (a) standard of care (SOC); (b) SOC plus
iEXPECT with phone-based
guidance (iEXPECT enhanced)
or (c) SOC plus iEXPECT with email-based
guidance
(iEXPECT limited). The intervention includes four 20 min
online modules addressing surgical benefits, side effects
and coping strategies. Modules are accompanied by
personalised guidance provided through feedback on each
module via email or telephone (three before surgery, three
booster sessions at 6, 12 and 18 weeks postsurgery).
Assessments occur at baseline (5–21 days before surgery),
preoperatively (day before surgery), 7 days postsurgery
and 6 months later. Primary feasibility outcomes include
recruitment (≥1 participant/week/centre), retention (≥49%
completing 6-month
follow-up
including biomarkers) and
engagement (≥75% completing ≥1 presurgery module).
Acceptability is measured by self-reported
enjoyment,
usefulness and impact, with acceptance defined as mean
scores >3.4 (5-point
Likert scale) and CSQ-I
ratings.
Secondary outcomes include psychological measures,
inflammatory markers and heart rate variability.
Ethics and dissemination: Ethical approval was granted
by the Ethics Committees of Philipps University Marburg
(AZ 229/23 BO) and the University of Giessen (AZ 186/23).
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Except where otherwise noted, this item's license is described as Attribution 4.0 International