The PREBEAT Trial: Digital PREhaBilitation in thE Cardiac Surgical populATion

Обзор

The goal of this randomised controlled trial is to learn if a digital prehabilitation program is feasible in patients awaiting cardiac surgery. The main questions it aims to answer are: 1. Is the digital health program usable? 2. Is the digital health program acceptable? 3. Do patients adhere to the digital health program? Researchers will compare a group using the digital prehabilitation program with standard care to see if the program is feasible and explore any differences in health outcomes. Participants will * Use a digital health mobile phone application to guide you through exercise, nutrition and preparation for surgery. * Engage in telehealth consultations. * Complete questionnaires * Complete exercise testing

Вмешательства

• Другое Digital Cardiac Prehabilitation
  Digital Cardiac Prehabilitation - A combined telehealth and app-based preparation for cardiac surgery
• Другое Control (Standard treatment)
  Standard preparation for surgery as per Melbourne Health hospital procedures and processes. This may include information sessions, pamphlets, and meetings with clinicians. This does not include a prehabilitation program.

Первичные конечные точки

• Usability of Digital Cardiac Prehabilitation as assessed by the Mhealth Application Usability Questionnaire (MAUQ) [Срок оценки: 1 day Pre-operatively]
• Adherence of Digital Cardiac Prehabilitation as measured by usage metrics from Mobile Phone App metrics [Срок оценки: 1 day Pre-operatively]
• Acceptability of Digital Cardiac Prehabilitation as measured by Theoretical Framework of Acceptability Questionnaire (TFA) [Срок оценки: 1 day Pre-operatively]
• Incidence of Adverse events [Срок оценки: Recorded through study completion, an anticipated average of 4 months.]

Вторичные конечные точки (12)

• Health service use as measured by Length of Stay (LOS) [Срок оценки: 2 weeks post-operatively]
• Health service use as measured by Intensive Care Unit (ICU) Length of Stay (ICU LOS) [Срок оценки: 2 weeks post-operatively]
• Mortality as measured by days alive out of hospital (DAoH) [Срок оценки: 30 days post-operatively]
• Health service use as measured by Readmissions [Срок оценки: 2 weeks, 30 days and 3 months post-operatively]
• Health service use as measured by the Health Utilization Questionnaire (HUQ) [Срок оценки: Assessed at Baseline, 1 day pre-operatively, then post-operatively at Time Points: 2 weeks, 30 days, and 3 months.]
• Cost of program delivery as estimated by multiplying the occasions of service by relevant national average hospital award wages for respective staff. [Срок оценки: 3 months post-operatively]
• Recovery as measured by the Post-Operative Quality of Recovery Scale (PostopQRS). [Срок оценки: Baseline, 1 day pre-operatively, Post operatively at Time Points: 1 day, 3 days, day of discharge, and 30 days.]
• Functional outcome as measured by the Functional Difficulties Questionnaire shortened (FDQs) [Срок оценки: Baseline, 1 day pre-operatively, Post operatively at day of discharge, 2 weeks, 30 days, and 3 months.]
• Body metrics as measured by Body Mass Index (BMI) [Срок оценки: Baseline, 3 months post-operatively.]
• Postoperative pulmonary complications (PPCs) as measured the Melbourne Group Score (MGS) [Срок оценки: Post operatively at Time Points: 1 day, 3 days, day of discharge and 30 days]
• Functional capacity as measured by 1-Minute Sit-to-Stand (1STS) [Срок оценки: Baseline, 1 day pre-operatively, Post operatively at day of discharge, 2 weeks, 30 days and 3 months.]
• Inspiratory muscle strength as measured by Maximal Inspiratory Pressure (MIP) [Срок оценки: Baseline, 1 day pre-operatively, and post-operatively at discharge.]

Критерии участия

Критерии включения

• 21 days+ prior to cardiac surgery
• Able to provide consent,
• Proficient in English to understand questionnaires, training instructions and outcome assessments.
• Digitally literate to independently navigate a smart device and novel application.

Критерии исключения

• severe or unstable neurological, cardiorespiratory, or musculoskeletal disease or mental illness that might compromise ability to perform exercise,
• unstable psychiatric or cognitive disorders,

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Австралия · 1 центр

• Melbourne Health (Royal Melbourne and Melbourne Private Hospital) — Melbourne

Публикации

• Steinmetz C, Bjarnason-Wehrens B, Walther T, Schaffland TF, Walther C. Efficacy of Prehabilitation Before Cardiac Surgery: A Systematic Review and Meta-analysis. Am J Phys Med Rehabil. 2023 Apr 1;102(4):323-330. doi: 10.1097/PHM.0000000000002097. Epub 2022 Sep 23. PMID 36149383
• Doyle MP, Indraratna P, Tardo DT, Peeceeyen SC, Peoples GE. Safety and efficacy of aerobic exercise commenced early after cardiac surgery: A systematic review and meta-analysis. Eur J Prev Cardiol. 2019 Jan;26(1):36-45. doi: 10.1177/2047487318798924. Epub 2018 Sep 6. PMID 30188177
• Kehler DS, Stammers AN, Tangri N, Hiebert B, Fransoo R, Schultz ASH, Macdonald K, Giacomontonio N, Hassan A, Legare JF, Arora RC, Duhamel TA. Systematic review of preoperative physical activity and its impact on postcardiac surgical outcomes. BMJ Open. 2017 Aug 11;7(8):e015712. doi: 10.1136/bmjopen-2016-015712. PMID 28801404
• Magon A, Caruso R, Sironi A, Mirabella S, Dellafiore F, Arrigoni C, Bonavina L. Trajectories of Health-Related Quality of Life, Health Literacy, and Self-Efficacy in Curatively-Treated Patients with Esophageal Cancer: A Longitudinal Single-Center Study in Italy. J Patient Exp. 2021 Nov 29;8:23743735211060769. doi: 10.1177/23743735211060769. eCollection 2021. PMID 35252557
• Nijkamp MD, Kenens CA, Dijker AJ, Ruiter RA, Hiddema F, Nuijts RM. Determinants of surgery related anxiety in cataract patients. Br J Ophthalmol. 2004 Oct;88(10):1310-4. doi: 10.1136/bjo.2003.037788. PMID 15377557
• Schroder H, Fito M, Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Lamuela-Raventos R, Ros E, Salaverria I, Fiol M, Lapetra J, Vinyoles E, Gomez-Gracia E, Lahoz C, Serra-Majem L, Pinto X, Ruiz-Gutierrez V, Covas MI. A short screener is valid for assessing Mediterranean diet adherence among older Spanish men and women. J Nutr. 2011 Jun;141(6):1140-5. doi: 10.3945/jn.110.135566. Epub 2 PMID 21508208
• Hulzebos EH, van Meeteren NL, van den Buijs BJ, de Bie RA, Brutel de la Riviere A, Helders PJ. Feasibility of preoperative inspiratory muscle training in patients undergoing coronary artery bypass surgery with a high risk of postoperative pulmonary complications: a randomized controlled pilot study. Clin Rehabil. 2006 Nov;20(11):949-59. doi: 10.1177/0269215506070691. PMID 17065538
• Birrer DL, Kuemmerli C, Obwegeser A, Liebi M, von Felten S, Pettersson K, Horisberger K. INSPIRA: study protocol for a randomized-controlled trial about the effect of spirometry-assisted preoperative inspiratory muscle training on postoperative complications in abdominal surgery. Trials. 2022 Jun 7;23(1):473. doi: 10.1186/s13063-022-06254-4. PMID 35672861

Идентификаторы

NCT: NCT06983808 · RMIT-HREC 28861 · RMH-HREC 2024.163

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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