My Cardiac Recovery (MyCaRe): A Pilot RCT.

Postoperative; Dysfunction Following Cardiac Surgery Clinical Trial

— MyCaRe  

Official title:

My Cardiac Recovery (MyCaRe): A Pilot RCT to Examine the Effect of MyCaRe Android Application on Recovery Outcomes and Enrolment in Cardiac Rehab Post Cardiac Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02778165
• Other study ID #: 15-9520
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: Tracey J Colella, PhD
• Phone: 4165973422
• Email: tracey.colella[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

MyCardiacRecovery (MyCaRe) is an interactive platform that includes a standardized educational format and interactive tracking (wound healing and activity progression using photo capabilities and Fitbit Inspire 2 accelerometer) support during the first 6 to 8 weeks post hospital discharge. This android application will help patients and family navigate their way through the continuum of care by providing an: a) integrated link between acute care and outpatient cardiac rehab (CR) for efficient coordination of information and reduction in duplication of services; b) patient care and education materials designed to address salient recovery questions; c) improved communication between the patient and care providers and, d) ensure streamlined systematic referral to CR. This innovative strategy has the potential to positively impact patient satisfaction, improve patient outcomes and possibly minimize financial constraints placed on the health care system. Phase 1 (preliminary usability testing) of prototype 1.0 is complete. Phase 2 will focus on testing MyCaRe 2.0 in a sample of post cardiac surgery patients using a pilot randomized controlled trial (RCT) design.

Description:

The early transition period post coronary artery bypass graft surgery is one associated with intense physiological and psychosocial adjustment that requires patients make sustainable long-term lifestyle changes. Cardiac rehabilitation (CR) is an evidence-based risk reduction program that has been shown to improve overall fitness and quality of life as well as lower morbidity and mortality in patients with coronary artery disease. Therefore, the development of supportive strategies to bridge the gap from acute care in to CR through early intervention for cardiac surgery patients is essential. MyCardiacRecovery (MyCaRe) is an interactive platform that includes a standardized educational format and interactive tracking (wound healing and activity progression using photo capabilities and Fitbit Inspire 2 accelerometer) support during the first 6 to 8 weeks post hospital discharge. This application will help patients and family navigate their way through the continuum of care by providing an: a) integrated link between acute care and outpatient cardiac rehab for efficient coordination of information and reduction in duplication of services; b) patient care and education materials designed to address salient recovery questions; c) improved communication between the patient and care providers and, d) ensure streamlined systematic referral to CR. This innovative strategy has the potential to positively impact patient satisfaction, improve patient outcomes and possibly minimize financial constraints placed on the health care system. Phase 1 (preliminary usability testing) of prototype 1.0 is complete. Phase 2 will focus on testing MyCaRe 2.0 in a sample of post cardiac surgery patients using a pilot randomized controlled trial design. Protocol Summary: App Study Phase 2 - Pilot Randomized Controlled Trial N= 40 (20 usual care + intervention; 20 usual care) Study Population: Post cardiac surgery patient population at 1 acute care cardiac centre in Toronto Study Design Pilot Randomized controlled trial Study Duration March 2022 - Dec 2022 Study Agent/ Intervention MyCaRe prototype (mobile application) Primary Objectives: 1) To examine the effect of MyCaRe application on enrolment in CR post cardiac surgery in comparison to usual care (assessing effectiveness of intervention); Secondary Objectives: 2) To examine the impact of MyCaRe application on patient recovery and satisfaction (i.e. knowledge level, perceptions of recovery outcomes such as activity progression, quality of life, anxiety and depression) 3) To examine the effect of MyCaRe application on health services use. 4) To examine patient and clinician satisfaction, specifically user ease, usability and comfort with MyCaRe application.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

The inclusion criteria for the sample includes:

1. comprehend/understand instructions for study and use of app/Fitbit,

2. > 35 years of age,

3. undergoing traditional (sternotomy approach) coronary artery bypass graft (CABG) surgery,

4. an uncomplicated postoperative course,

5. standard length of hospital stay (four to eight days),

6. access to wifi internet in their home,

7. able to hear telephone conversation,

8. reside within the greater Toronto region (GTA) or if outside GTA willing to return devices via mail upon completion of study.

Exclusion Criteria:

• The exclusion criteria will include those persons who:

1. have cardiac surgery procedures other than CABG,

2. reside in a nursing home or long term care facility,

3. have any neurological or psychiatric disorder that may impede their ability to self reflect or communicate,

4. sustained in-hospital post surgical complications of major significance (such as stroke, deep wound infections, pericardial effusion, etc.), 5) inability to ambulate (i.e. walk unaided at 2 mph).

Related Conditions & MeSH terms

• Postoperative; Dysfunction Following Cardiac Surgery

Intervention

Other:
• MyCaRe (my cardiac recovery Android application)
Android application & Fitbit Inspire 2 activity monitor

Locations

Country	Name	City	State
Canada	Cardiac Rehabilitation, Rumsey Centre, TRI-UHN	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Toronto General Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (55)

. Liu J. Seamless Mobile Health. 2012. Retrieved May 28, 2013 from www.seamlessmobilehealth.ca

Alter DA, Oh PI, Chong A. Relationship between cardiac rehabilitation and survival after acute cardiac hospitalization within a universal health care system. Eur J Cardiovasc Prev Rehabil. 2009 Feb;16(1):102-13. doi: 10.1097/HJR.0b013e328325d662. — View Citation

Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67. — View Citation

Arthur HM, Suskin N, Bayley M, Fortin M, Howlett J, Heckman G, Lewanczuk R. The Canadian Heart Health Strategy and Action Plan: Cardiac rehabilitation as an exemplar of chronic disease management. Can J Cardiol. 2010 Jan;26(1):37-41. doi: 10.1016/s0828-282x(10)70336-6. — View Citation

Artinian NT, Duggan CH. Sex differences in patient recovery patterns after coronary artery bypass surgery. Heart Lung. 1995 Nov-Dec;24(6):483-94. doi: 10.1016/s0147-9563(95)80026-3. — View Citation

Bandura, A. (1986). Social foundation of thought and action: A social cognitive theory. Englewood Cliffs, NJ: Prentice-Hall.

Berkman LF, Blumenthal J, Burg M, Carney RM, Catellier D, Cowan MJ, Czajkowski SM, DeBusk R, Hosking J, Jaffe A, Kaufmann PG, Mitchell P, Norman J, Powell LH, Raczynski JM, Schneiderman N; Enhancing Recovery in Coronary Heart Disease Patients Investigators (ENRICHD). Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial. JAMA. 2003 Jun 18;289(23):3106-16. doi: 10.1001/jama.289.23.3106. — View Citation

Brooke J. The system usability scale. http://www.usability.gov/how-to-and-tools/methods/system-usability-scale.html

Cardiac Care Network of Ontario. Report on adult cardiac surgery in Ontario. Retrieved July 2, 2013 at http://www.ccn.ca/ccc public/uploadfiles/files/Provincial%21 Cardiac%20Surgery%20Reports%20-%20Final%20Draft.pdf

Chunta KS. Expectations, anxiety, depression, and physical health status as predictors of recovery in open-heart surgery patients. J Cardiovasc Nurs. 2009 Nov-Dec;24(6):454-64. doi: 10.1097/JCN.0b013e3181ac8a3c. — View Citation

Cohen, S., Underwood, L.G. & Gottlieb, B.H. (2000). Social support measurement and intervention: A guide for health and social scientists. New York: Oxford University Press

Colella TJ, Gravely S, Marzolini S, Grace SL, Francis JA, Oh P, Scott LB. Sex bias in referral of women to outpatient cardiac rehabilitation? A meta-analysis. Eur J Prev Cardiol. 2015 Apr;22(4):423-41. doi: 10.1177/2047487314520783. Epub 2014 Jan 28. — View Citation

Colella TJF, King KM. The effect of a professionally-guided telephone peer support intervention on early recovery outcomes in men following coronary artery bypass graft surgery. Doctoral dissertation University of Calgary, CAN. Under review Soc Sci Med, 2016.

Cook D, et al. (Discovery Project). Mayo Clinic pilots myCare iPad app for cardiac surgery support, engaging patients & families. Feb, 5, 2013; Retrieved from: http://consumerehealthengagement.squarespace.com/consumerehealthengagement/2013/2/5/mayo-pilots-mycare-ipad-app-for-cardiac-surgery-support-enga.html

Dafoe W, Arthur H, Stokes H, Morrin L, Beaton L; Canadian Cardiovascular Society Access to Care Working Group on Cardiac Rehabilitation. Universal access: but when? Treating the right patient at the right time: access to cardiac rehabilitation. Can J Cardiol. 2006 Sep;22(11):905-11. doi: 10.1016/s0828-282x(06)70309-9. — View Citation

Dempster M, Donnelly M, Fitzsimmon D. Generic, disease-specific and individualized approaches to measuring health -related quality of life among people with heart disease - a comparative analysis. Psychology & Health. 2002 ;17 ;447-457.

Freund T, Gensichen J, Goetz K, Szecsenyi J, Mahler C. Evaluating self-efficacy for managing chronic disease: psychometric properties of the six-item Self-Efficacy Scale in Germany. J Eval Clin Pract. 2013 Feb;19(1):39-43. doi: 10.1111/j.1365-2753.2011.01764.x. Epub 2011 Aug 23. — View Citation

Gardner JK, McConnell TR, Klinger TA, Herman CP, Hauck CA, Laubach CA Jr. Quality of life and self-efficacy: gender and diagnoses considerations for management during cardiac rehabilitation. J Cardiopulm Rehabil. 2003 Jul-Aug;23(4):299-306. doi: 10.1097/00008483-200307000-00007. — View Citation

Giannakidou DM, Kambas A, Ageloussis N, Fatouros I, Christoforidis C, Venetsanou F, Douroudos I, Taxildaris K. The validity of two Omron pedometers during treadmill walking is speed dependent. Eur J Appl Physiol. 2012 Jan;112(1):49-57. doi: 10.1007/s00421-011-1951-y. Epub 2011 Apr 9. — View Citation

Goodman H. Patients' perceptions of their education needs in the first six weeks following discharge after cardiac surgery. J Adv Nurs. 1997 Jun;25(6):1241-51. doi: 10.1046/j.1365-2648.1997.19970251241.x. — View Citation

Gortner S.R., Jaeger A.A., Harr J., & Hlatky M.A. Elders' recovery from cardiac surgery: Is gender a factor? Journal of Myocardial Ischemia, 1994; 6(9), 17-25.

Grace SL, Chessex C, Arthur H, Chan S, Cyr C, Dafoe W, Juneau M, Oh P, Suskin N. Systematizing Inpatient Referral to Cardiac Rehabilitation 2010: Canadian association of cardiac rehabilitation and Canadian cardiovascular society joint position paper. J Cardiopulm Rehabil Prev. 2011 May-Jun;31(3):E1-8. doi: 10.1097/HCR.0b013e318219721f. — View Citation

Grace SL, Gravely-Witte S, Kayaniyil S, Brual J, Suskin N, Stewart DE. A multisite examination of sex differences in cardiac rehabilitation barriers by participation status. J Womens Health (Larchmt). 2009 Feb;18(2):209-16. doi: 10.1089/jwh.2007.0753. — View Citation

Grace SL, Shanmugasegaram S, Gravely-Witte S, Brual J, Suskin N, Stewart DE. Barriers to cardiac rehabilitation: DOES AGE MAKE A DIFFERENCE? J Cardiopulm Rehabil Prev. 2009 May-Jun;29(3):183-7. doi: 10.1097/HCR.0b013e3181a3333c. — View Citation

Hamalainen H, Smith R, Puukka P, Lind J, Kallio V, Kuttila K, Ronnemaa T. Social support and physical and psychological recovery one year after myocardial infarction or coronary artery bypass surgery. Scand J Public Health. 2000 Mar;28(1):62-70. doi: 10.1177/140349480002800111. — View Citation

Hirano, SH, Tang KP, Cheng KG, Hayes GR. The Estrellita system: A health informatics tools to support caregivers of preterm infants 2012; doi 10.4108/cst.pervasivehealth.2012.248718

Jackson L, Leclerc J, Erskine Y, Linden W. Getting the most out of cardiac rehabilitation: a review of referral and adherence predictors. Heart. 2005 Jan;91(1):10-4. doi: 10.1136/hrt.2004.045559. — View Citation

King KM, Gortner SR. Women's short-term recovery from cardiac surgery. Prog Cardiovasc Nurs. 1996 Spring;11(2):5-15. — View Citation

King KM. Gender and short-term recovery from cardiac surgery. Nurs Res. 2000 Jan-Feb;49(1):29-36. doi: 10.1097/00006199-200001000-00005. — View Citation

Kmill C, Sherrington L, Third G. Increasing access to cardiac rehabilitation through telemedicine technology. Can Nurse. 2007 May;103(5):8-9. No abstract available. — View Citation

Lapum J, Angus JE, Peter E, Watt-Watson J. Patients' discharge experiences: returning home after open-heart surgery. Heart Lung. 2011 May-Jun;40(3):226-35. doi: 10.1016/j.hrtlng.2010.01.001. Epub 2010 Apr 14. — View Citation

Lawson, Telus Health, Canada Health Infoway and Mental Health Engagement Network retrieved on July 2, 2013 at http://www.telushealth.com/news-and-events/news-releases/release/2012/10/12/lawson-telus-health-and-canada-health-infoway-launch-the-mental-health-engagement-network-initiative-to-measure-effectiveness-of-new-technology-in-ongoing-health-management

Li J, Siegrist J. Physical activity and risk of cardiovascular disease--a meta-analysis of prospective cohort studies. Int J Environ Res Public Health. 2012 Feb;9(2):391-407. doi: 10.3390/ijerph9020391. Epub 2012 Jan 26. — View Citation

Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01. — View Citation

Maddison R, Whittaker R, Stewart R, Kerr A, Jiang Y, Kira G, Carter KH, Pfaeffli L. HEART: heart exercise and remote technologies: a randomized controlled trial study protocol. BMC Cardiovasc Disord. 2011 May 31;11:26. doi: 10.1186/1471-2261-11-26. — View Citation

McConnell TR, Laubach CA, Memon M, Gardner JK, Klinger TA, Palm RJ. Quality of Life and Self Efficacy in Cardiac Rehabilitation Patients Over 70 Years of Age Following Acute Myocardial Infarction and Bypass Revascularization Surgery. Am J Geriatr Cardiol. 2000 Jul;9(4):210-218. doi: 10.1111/j.1076-7460.2000.80040.x. — View Citation

Meleis AI. Transition Theory. Middle range and situation specific theories in nursingresearch and practice. 2010. Springer Publishing: New York.

Mitchell PH, Powell L, Blumenthal J, Norten J, Ironson G, Pitula CR, Froelicher ES, Czajkowski S, Youngblood M, Huber M, Berkman LF. A short social support measure for patients recovering from myocardial infarction: the ENRICHD Social Support Inventory. J Cardiopulm Rehabil. 2003 Nov-Dec;23(6):398-403. doi: 10.1097/00008483-200311000-00001. No abstract available. — View Citation

Oldridge N. Exercise-based cardiac rehabilitation in patients with coronary heart disease: meta-analysis outcomes revisited. Future Cardiol. 2012 Sep;8(5):729-51. doi: 10.2217/fca.12.34. — View Citation

Parent N, Fortin F. A randomized, controlled trial of vicarious experience through peer support for male first-time cardiac surgery patients: impact on anxiety, self-efficacy expectation, and self-reported activity. Heart Lung. 2000 Nov-Dec;29(6):389-400. doi: 10.1067/mhl.2000.110626. — View Citation

Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP; Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Secondary prevention through cardiac rehabilitation: from knowledge to implementation. A position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2010 Feb;17(1):1-17. doi: 10.1097/HJR.0b013e3283313592. — View Citation

Reid RD, Morrin LI, Beaton LJ, Papadakis S, Kocourek J, McDonnell L, Slovinec D'Angelo ME, Tulloch H, Suskin N, Unsworth K, Blanchard C, Pipe AL. Randomized trial of an internet-based computer-tailored expert system for physical activity in patients with heart disease. Eur J Prev Cardiol. 2012 Dec;19(6):1357-64. doi: 10.1177/1741826711422988. Epub 2011 Sep 8. — View Citation

Ritchie C, Richman J, Sobko H, Bodner E, Phillips B, Houston T. The E-coach transition support computer telephony implementation study: protocol of a randomized trial. Contemp Clin Trials. 2012 Nov;33(6):1172-9. doi: 10.1016/j.cct.2012.08.007. Epub 2012 Aug 19. — View Citation

Schuler G, Adams V, Goto Y. Role of exercise in the prevention of cardiovascular disease: results, mechanisms, and new perspectives. Eur Heart J. 2013 Jun;34(24):1790-9. doi: 10.1093/eurheartj/eht111. Epub 2013 Apr 7. — View Citation

Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial. J Med Internet Res. 2012 Feb 16;14(1):e31. doi: 10.2196/jmir.1909. — View Citation

Shanmugasegaram S, Gagliese L, Oh P, Stewart DE, Brister SJ, Chan V, Grace SL. Psychometric validation of the cardiac rehabilitation barriers scale. Clin Rehabil. 2012 Feb;26(2):152-64. doi: 10.1177/0269215511410579. Epub 2011 Sep 21. — View Citation

Sieverdes JC, Treiber F, Jenkins C, Hermayer K. Improving diabetes management with mobile health technology. Am J Med Sci. 2013 Apr;345(4):289-295. doi: 10.1097/MAJ.0b013e3182896cee. — View Citation

Stewart, M.J. (1993). Integrating social support in nursing. Newbury Park: Sage.

Takacs J, Pollock CL, Guenther JR, Bahar M, Napier C, Hunt MA. Validation of the Fitbit One activity monitor device during treadmill walking. J Sci Med Sport. 2014 Sep;17(5):496-500. doi: 10.1016/j.jsams.2013.10.241. Epub 2013 Oct 31. — View Citation

Taylor RS, Brown A, Ebrahim S, Jolliffe J, Noorani H, Rees K, Skidmore B, Stone JA, Thompson DR, Oldridge N. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004 May 15;116(10):682-92. doi: 10.1016/j.amjmed.2004.01.009. — View Citation

Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1. Erratum In: BMC Med Res Methodol. 2023 Mar 11;23(1):59. — View Citation

Topol, E. The creative destruction of medicine: How the digital revolution will create better health care, 2012; Basic, New York.

Whelan-Goodinson R, Ponsford J, Schonberger M. Validity of the Hospital Anxiety and Depression Scale to assess depression and anxiety following traumatic brain injury as compared with the Structured Clinical Interview for DSM-IV. J Affect Disord. 2009 Apr;114(1-3):94-102. doi: 10.1016/j.jad.2008.06.007. Epub 2008 Jul 25. — View Citation

World Health Organization (WHO). 2005 Facing the facts: The impact of chronic disease in Canada. Retrieved May 4, 2011 at http://www.who.int/chp/chronic_disease_report/en/

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. — View Citation

* Note: There are 55 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrolment in cardiac rehabilitation	The number of individuals who attend their initial cardiac rehab intake appointment will be the primary outcome measure of enrollment. Enrollment is defined in accordance with Canadian Cardiovascular Society data definitions (http://bridge.ccs.ca/index.php/en/), as patient having attended their scheduled cardiac rehab intake appointment (i.e., risk factor assessment, goal-setting). Enrollment will be verified with patient as well as with the CR program in which they are enrolled.	8 weeks post operative discharge