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Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol

Authors: Leila Pfaeffli Dale, Robyn Whittaker, Yannan Jiang, Ralph Stewart, Anna Rolleston, Ralph Maddison

Published in: Trials | Issue 1/2014

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Abstract

Background

Cardiac rehabilitation (CR) is a secondary prevention program that offers education and support to assist patients with coronary heart disease (CHD) make lifestyle changes. Despite the benefits of CR, attendance at centre-based sessions remains low. Mobile technology (mHealth) has potential to reach more patients by delivering CR directly to mobile phones, thus providing an alternative to centre-based CR. The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours (for example, physically active, fruit and vegetable intake, not smoking, low alcohol consumption) over and above usual CR services in New Zealand adults diagnosed with CHD.

Methods/design

A two-arm, parallel, randomised controlled trial will be conducted at two Auckland hospitals in New Zealand. One hundred twenty participants will be randomised to receive a 24-week evidence- and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone (control). The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months, measured using a composite health behaviour score. Secondary outcomes include overall cardiovascular disease risk, body composition, illness perceptions, self-efficacy, hospital anxiety/depression and medication adherence.

Discussion

This study is one of the first to examine an mHealth-delivered comprehensive CR program. Strengths of the trial include quality research design and in-depth description of the intervention to aid replication. If effective, the trial has potential to augment standard CR practices and to be used as a model for other disease prevention or self-management programs.

Trial registry

Australian New Zealand Clinical Trials Registry:ACTRN12613000901​707
Appendix
Available only for authorised users
Literature
1.
Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P: Heart disease and stroke statistics–2010 update: a report from the American Heart Association. Circulation. 2010, 121: e46-e215. Published errata appear in Circulation 2010, 121:e260; Circulation 2011, 124:e425CrossRefPubMed
2.
Danaei G, Ding EL, Mozaffarian D, Taylor B, Rehm J, Murray CJL, Ezzati M: The preventable causes of death in the United States: comparative risk assessment of dietary, lifestyle, and metabolic risk factors. PLoS Med. 2009, 6: e1000058-10.1371/journal.pmed.1000058.CrossRefPubMedPubMedCentral
3.
4.
Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS: Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011, 7: CD001800
5.
Lawler PR, Filion KB, Eisenberg MJ: Efficacy of exercise-based cardiac rehabilitation post–myocardial infarction: a systematic review and meta-analysis of randomized controlled trials. Am Heart J. 2011, 162: 571-584.e2-CrossRefPubMed
6.
Beauchamp A, Worcester M, Ng A, Murphy B, Tatoulis J, Grigg L, Newman R, Goble A: Attendance at cardiac rehabilitation is associated with lower all-cause mortality after 14 years of follow-up. Heart. 2013, 99: 620-625. 10.1136/heartjnl-2012-303022.CrossRefPubMed
7.
Rauch B, Riemer T, Schwaab B, Schneider S, Diller F, Gohlke H, Schiele R, Katus H, Gitt A, Senges J, for the OMEGA study group: Short-term comprehensive cardiac rehabilitation after AMI is associated with reduced 1-year mortality: results from the OMEGA study. Eur J Prev Cardiol. [Epub ahead of print]. doi:10.1177/2047487313486040
8.
9.
Balady GJ, Williams MA, Ades PA, Bittner V, Comoss P, Foody JM, Franklin B, Sanderson B, Southard D: AHA/AACVPR Scientific Statement: Core components of cardiac rehabilitation/secondary prevention programs: 2007 Update. A scientific statement from the American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and Metabolism; and the American Association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2007, 115: 2675-2682. 10.1161/CIRCULATIONAHA.106.180945.CrossRefPubMed
10.
11.
Bjarnason-Wehrens B, McGee H, Zwisler AD, Piepoli MF, Benzer W, Schmid JP, Dendale P, Pogosova NG, Zdrenghea D, Niebauer J, Mendes M, Squarta S, Pfaff C, Benzer W, Marko C, Sujayeva SG, Dendale P, Cerovec D, Karel I, Antoniades L, Sjøl A, Rantala M, Vergés B, Bönner G, Ritter P, Simon A, Jónsdóttir S, Jónasson M, Love J, Griffo R: Cardiac rehabilitation in Europe: results from the European Cardiac Rehabilitation Inventory Survey. Eur J Cardiovasc Prev Rehabil. 2010, 17: 410-418. 10.1097/HJR.0b013e328334f42d.CrossRefPubMed
12.
Doolan-Noble F, Broad J, Riddell T, North D: Cardiac rehabilitation services in New Zealand: access and utilisation. NZ Med J. 2004, 117: U955-
13.
Suaya JA, Shepard DS, Normand SLT, Ades PA, Prottas J, Stason WB: Use of cardiac rehabilitation by Medicare beneficiaries after myocardial infarction or coronary bypass surgery. Circulation. 2007, 116: 1653-1662. 10.1161/CIRCULATIONAHA.107.701466.CrossRefPubMed
14.
Taylor GH, Wilson SL, Sharp J: Medical, psychological, and sociodemographic factors associated with adherence to cardiac rehabilitation programs: a systematic review. J Cardiovasc Nurs. 2011, 26: 202-209. 10.1097/JCN.0b013e3181ef6b04.CrossRefPubMed
15.
Clark AM, King-Shier KM, Thompson DR, Spaling MA, Duncan AS, Stone JA, Jaglal SB, Angus JE: A qualitative systematic review of influences on attendance at cardiac rehabilitation programs after referral. Am Heart J. 2012, 164: 835-845.e2-CrossRef
16.
Neubeck L, Freedman SB, Clark AM, Briffa T, Bauman A, Redfern J: Participating in cardiac rehabilitation: a systematic review and meta-synthesis of qualitative data. Eur J Prev Cardiol. 2012, 19: 494-503. 10.1177/1741826711409326.CrossRefPubMed
17.
Fjeldsoe BS, Marshall AL, Miller YD: Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009, 36: 165-173. 10.1016/j.amepre.2008.09.040.CrossRefPubMed
18.
Cole-Lewis H, Kershaw T: Text messaging as a tool for behavior change in disease prevention and management. Epidemiol Rev. 2010, 32: 56-69. 10.1093/epirev/mxq004.CrossRefPubMedPubMedCentral
19.
Maddison R, Whittaker R, Stewart R, Kerr A, Jiang A, Kira G, Carter KH, Pfaeffli L: HEART: Heart Exercise and Remote Technologies: a randomized controlled trial study protocol. BMC Cardiovasc Disord. 2011, 11: 26-10.1186/1471-2261-11-26.CrossRefPubMedPubMedCentral
20.
Carter K, Maddison R, Whittaker R, Stewart R, Kerr A, Jiang Y, Pfaeffli L, Rawstorn J: Heart: efficacy of a mHealth exercise-based cardiac rehabilitation program. Heart Lung Circ. 2013, 22: 553-CrossRef
21.
Pfaeffli L, Maddison R, Whittaker R, Stewart R, Kerr A, Jiang Y, Kira G, Carter KH: Heart Exercise and Remote Technologies (HEART): perceptions of a mHealth exercise-based cardiac rehabilitation intervention. Ann Behav Med. 2013, 45 (2 Suppl): s245-
22.
Free C, Knight R, Robertson S, Whittaker R, Edwards P, Zhou W, Rodgers A, Cairns J, Kenward MG, Roberts I: Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial. Lancet. 2011, 378: 49-55. 10.1016/S0140-6736(11)60701-0.CrossRefPubMedPubMedCentral
23.
Drake BF, Quintiliani LM, Sapp AL, Li Y, Harley AE, Emmons KM, Sorensen G: Comparing strategies to assess multiple behavior change in behavioral intervention studies. Transl Behav Med. 2013, 3: 114-121. 10.1007/s13142-013-0195-2.CrossRefPubMedPubMedCentral
24.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D: SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013, 158: 200-207. 10.7326/0003-4819-158-3-201302050-00583.CrossRefPubMed
25.
Eysenbach G, CONSORT-EHEALTH Group: CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011, 13: e126-10.2196/jmir.1923.CrossRefPubMedPubMedCentral
26.
Chan WC, Wright C, Tobias M, Mann S, Jackson R: Explaining trends in coronary heart disease hospitalisations in New Zealand: trend for admissions and incidence can be in opposite directions. Heart. 2008, 94: 1589-1593. 10.1136/hrt.2008.142588.CrossRefPubMed
27.
Khaw KT, Wareham N, Bingham S, Welch A, Luben R, Day N: Combined impact of health behaviours and mortality in men and women: The EPIC-Norfolk Prospective Population Study. PLoS Med. 2008, 5: e12-10.1371/journal.pmed.0050012. A published erratum appears in PLoS Med 2008, 5:e70CrossRefPubMedPubMedCentral
28.
ACSM’s Guidelines for Exercise Testing and Prescription. Edited by: Thompson WR, Gordon NF, Pescatello LS, American College of Sports Medicine. 2010, Philadelphia, PA: Lippincott Williams & Wilkins, 8
29.
Whittaker R, Dorey E, Bramley D, Bullen C, Denny S, Elley CR, Maddison R, McRobbie H, Parag V, Rodgers A, Salmon P: A theory-based video messaging mobile phone intervention for smoking cessation: randomized controlled trial. J Med Internet Res. 2011, 13: e10-10.2196/jmir.1553.CrossRefPubMedPubMedCentral
30.
Whittaker R, Merry S, Stasiak K, McDowell H, Doherty I, Shepherd M, Dorey E, Parag V, Ameratunga S, Rodgers A: MEMO–a mobile phone depression prevention intervention for adolescents: development process and postprogram findings on acceptability from a randomized controlled trial. J Med Internet Res. 2012, 14: e13-10.2196/jmir.1857.CrossRefPubMedPubMedCentral
31.
Cameron LD, Jago L: Emotion regulation interventions: a common-sense model approach. Br J Health Psychol. 2008, 13: 215-221. 10.1348/135910708X288800.CrossRefPubMed
32.
Broadbent E, Ellis CJ, Thomas J, Gamble G, Petrie KJ: Further development of an illness perception intervention for myocardial infarction patients: a randomized controlled trial. J Psychosom Res. 2009, 67: 17-23. 10.1016/j.jpsychores.2008.12.001.CrossRefPubMed
33.
Rodgers A, Corbett T, Bramley D, Riddell T, Wills M, Lin RB, Jones M: Do u smoke after txt? Results of a randomised trial of smoking cessation using mobile phone text messaging. Tob Control. 2005, 14: 255-261. 10.1136/tc.2005.011577.CrossRefPubMedPubMedCentral
34.
Bandura A: Health promotion by social cognitive means. Health Educ Behav. 2004, 31: 143-164. 10.1177/1090198104263660.CrossRefPubMed
35.
Sharp PB, Salyer J: Self-efficacy and barriers to healthy diet in cardiac rehabilitation participants and nonparticipants. J Cardiovasc Nurs. 2012, 27: 253-262. 10.1097/JCN.0b013e31821efdc2.CrossRefPubMed
36.
Bandura A: Health promotion from the perspective of social cognitive theory. Psychol Health. 1998, 13: 623-649. 10.1080/08870449808407422.CrossRef
37.
Abraham C, Michie S: A taxonomy of behavior change techniques used in interventions. Health Psychol. 2008, 27: 379-387.CrossRefPubMed
38.
Ferrier S, Blanchard CM, Vallis M, Giacomantonio N: Behavioural interventions to increase the physical activity of cardiac patients: a review. Eur J Cardiovasc Prev Rehabil. 2011, 18: 15-32.PubMed
39.
Aldcroft SA, Taylor NF, Blackstock FC, O’Halloran PD: Psychoeducational rehabilitation for health behavior change in coronary artery disease: a systematic review of controlled trials. J Cardiopulm Rehabil Prev. 2011, 31: 273-281. 10.1097/HCR.0b013e318220a7c9.CrossRefPubMed
40.
Riley WT, Rivera DE, Atienza AA, Nilsen W, Allison SM, Mermelstein R: Health behavior models in the age of mobile interventions: Are our theories up to the task?. Transl Behav Med. 2011, 1: 53-71. 10.1007/s13142-011-0021-7.CrossRefPubMedPubMedCentral
41.
Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, Patel V, Haines A: The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review. PLoS Med. 2013, 10: e1001362-10.1371/journal.pmed.1001362.CrossRefPubMedPubMedCentral
42.
Maddison R, Roberts V, Bullen C, McRobbie H, Jiang Y, Prapavessis H, Glover M, Taylor S, Brown P: Design and conduct of a pragmatic randomized controlled trial to enhance smoking-cessation outcomes with exercise: the Fit2Quit study. Ment Health Phys Act . 2010, 3: 92-101. 10.1016/j.mhpa.2010.09.003.CrossRef
43.
Godin G, Shephard RJ: A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985, 10: 141-146.PubMed
44.
Hunt-Shanks T, Blanchard C, Reid RD: Gender differences in cardiac patients: a longitudinal investigation of exercise, autonomic anxiety, negative affect and depression. Psychol Health Med. 2009, 14: 375-385. 10.1080/13548500902866939.CrossRefPubMed
45.
Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA: The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998, 158: 1789-1795. 10.1001/archinte.158.16.1789.CrossRefPubMed
46.
47.
D’Agostino RB, Russell MW, Huse DM, Ellison RC, Silbershatz H, Wilson PWF, Hartz SC: Primary and subsequent coronary risk appraisal: new results from the Framingham study. Am Heart J. 2000, 139: 272-281.CrossRefPubMed
48.
Broadbent E, Petrie KJ, Main J, Weinman J: The Brief Illness Perception Questionnaire. J Psychosom Res. 2006, 60: 631-637. 10.1016/j.jpsychores.2005.10.020.CrossRefPubMed
49.
Morisky DE, Ang A, Krousel-Wood M, Ward HJ: Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008, 10: 348-354. 10.1111/j.1751-7176.2008.07572.x.CrossRef
50.
Krousel-Wood M, Islam T, Webber LS, Re RN, Morisky DE, Muntner P: New medication adherence scale versus pharmacy fill rates in seniors with hypertension. Am J Manag Care. 2009, 15: 59-66.PubMedPubMedCentral
51.
Lorig KR, Ritter PL, Laurent DD, Plant K: Internet-based chronic disease self-management: a randomized trial. Med Care. 2006, 44: 964-971. 10.1097/01.mlr.0000233678.80203.c1.CrossRefPubMed
52.
53.
Kaplan RM, Stone AA: Bringing the laboratory and clinic to the community: mobile technologies for health promotion and disease prevention. Annu Rev Psychol. 2013, 64: 471-498. 10.1146/annurev-psych-113011-143736.CrossRefPubMed
54.
Buchholz SW, Wilbur J, Ingram D, Fogg L: Physical activity text messaging interventions in adults: a systematic review. Worldviews Evid Based Nurs. 2013, 10: 163-173. 10.1111/wvn.12002.CrossRefPubMed
55.
Pfaeffli L, Maddison R, Whittaker R, Stewart R, Kerr A, Jiang Y, Kira G, Carter K, Dalleck L: A mHealth cardiac rehabilitation exercise intervention: findings from content development studies. BMC Cardiovasc Disord. 2012, 12: 36-10.1186/1471-2261-12-36.CrossRefPubMedPubMedCentral
Metadata
Title
Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol
Authors
Leila Pfaeffli Dale
Robyn Whittaker
Yannan Jiang
Ralph Stewart
Anna Rolleston
Ralph Maddison
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-71

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