Feasibility and Clinical Relevance of a Mobile Intervention Using TrackPAD to Support Supervised Exercise Therapy in Patients With Peripheral Arterial Disease: Study Protocol for a Randomized Controlled Pilot Trial

Katrin Paldán, Jan Simanovski, Greta Ullrich, Martin Steinmetz, Christos Rammos, Rolf Alexander Jánosi, Susanne Moebus, Tienush Rassaf, Julia Lortz, Katrin Paldán, Jan Simanovski, Greta Ullrich, Martin Steinmetz, Christos Rammos, Rolf Alexander Jánosi, Susanne Moebus, Tienush Rassaf, Julia Lortz

Abstract

Background: Peripheral arterial disease (PAD) is a common and severe disease with a highly increased cardiovascular morbidity and mortality. Through the circulatory disorder and the linked undersupply of oxygen carriers in the lower limbs, the ongoing decrease of the pain-free walking distance occurs with a significant reduction in patients' quality of life. Studies including activity monitoring for patients with PAD are rare and digital support to increase activity via mobile health technologies is mainly targeted at patients with cardiovascular disease in general. The special requirement of patients with PAD is the need to reach a certain pain level to improve the pain-free walking distance. Unfortunately, both poor adherence and availability of institutional resources are major problems in patient-centered care.

Objective: The objective of this trackPAD pilot study is to evaluate the feasibility of a mobile phone-based self tracking app to promote physical activity and supervised exercise therapy (SET) in particular. We also aim for a subsequent patient centered adjustment of the app prototype based on the results of the app evaluation and process evaluation.

Methods: This study was designed as a closed user group trial, with assessors blinded, and parallel group study with face-to-face components for assessment with a follow-up of 3 months. Patients with symptomatic PAD (Fontaine stage IIa or IIb) and possession of a mobile phone were eligible. Eligible participants were randomly assigned into study and control group, stratified by their distance covered in the 6-min walk test, using the software TENALEA. Participants randomized to the study group received usual care and the mobile intervention (trackPAD) for the follow-up period of 3 months, whereas participants randomized to the control group received only usual care. TrackPAD records the frequency and duration of training sessions and pain level using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (6-min walk test, ankle-brachial index, and duplex ultrasound at the lower arteries) and self-reported quality of life. Usability and quality of the app was determined using the user version of the Mobile Application Rating Scale.

Results: The study enrolled 45 participants with symptomatic PAD (44% male). Of these participants, 21 (47%) were randomized to the study group and 24 (53%) were randomized to the control group. The distance walked in the 6-min walk test was comparable in both groups at baseline (study group: mean 368.1m [SD 77.6] vs control group: mean 394.6m [SD 100.6]).

Conclusions: This is the first trial to test a mobile intervention called trackPAD that was designed especially for patients with PAD. Its results will provide important insights in terms of feasibility, effectiveness, and patient preferences of an app-based mobile intervention supporting SET for the conservative treatment of PAD.

International registered report identifier (irrid): DERR1-10.2196/13651.

Keywords: patient compliance; patient participation; peripheral arterial disease; primary health care; telemedicine.

Conflict of interest statement

Conflicts of Interest: None declared.

©Katrin Paldán, Jan Simanovski, Greta Ullrich, Martin Steinmetz, Christos Rammos, Rolf Alexander Jánosi, Susanne Moebus, Tienush Rassaf, Julia Lortz. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.06.2019.

Figures

Figure 1
Figure 1
Main view of trackPAD. Weekly progress overview (upper part) and time bar active while training (central part). The main view also offers the possibility to access personal achievements (lower left part) or the leaderboard (lower right part). FAQ: frequently asked questions; SET: supervised exercise training.
Figure 2
Figure 2
Claudication reminder. After starting each supervised exercise training (SET) unit a pop-up appears reminding that a certain claudication level should be reached following a short break and repetition. The pop-up needs to be actively confirmed to begin the SET.
Figure 3
Figure 3
Personal achievements page. Reaching personal achievements unlocks medals in the medal mirror. The numbers at the right indicate the number of possible medals to unlock (eg, gold medal, silver medal, bronze medal). SET: supervised exercise training.
Figure 4
Figure 4
Leaderboard page. Different categories of leaderboards are included. Each gives the opportunity to improve the personal placement within the group. The evaluation process at the follow-up will bring further insights about which kind of leaderboard has the most impact regarding motivational aspects. SET: supervised exercise training.
Figure 5
Figure 5
Quantitative development of screened patients until the beginning of trackPAD use. Reasons for dropouts and exclusions are shown.

References

    1. Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329–40. doi: 10.1016/S0140-6736(13)61249-0.
    1. Pande R, Perlstein T, Beckman J, Creager MA. Secondary prevention and mortality in peripheral artery disease: National Health and Nutrition Examination Study, 1999 to 2004. Circulation. 2011 Jul 05;124(1):17–23. doi: 10.1161/CIRCULATIONAHA.110.003954.
    1. Marso SP, Hiatt WR. Peripheral arterial disease in patients with diabetes. J Am Coll Cardiol. 2006 Mar 07;47(5):921–9. doi: 10.1016/j.jacc.2005.09.065.
    1. Cacoub P, Cambou J, Kownator S, Belliard J, Beregi J, Branchereau A, Carpentier P, Léger P, Luizy F, Maïza D, Mihci E, Herrmann M, Priollet P. Prevalence of peripheral arterial disease in high-risk patients using ankle-brachial index in general practice: a cross-sectional study. Int J Clin Pract. 2009 Jan;63(1):63–70. doi: 10.1111/j.1742-1241.2008.01953.x. doi: 10.1111/j.1742-1241.2008.01953.x.
    1. Harwood AE, Smith GE, Cayton T, Broadbent E, Chetter IC. A systematic review of the uptake and adherence rates to supervised exercise programs in patients with intermittent claudication. Ann Vasc Surg. 2016 Jul;34:280–9. doi: 10.1016/j.avsg.2016.02.009.
    1. Lindo FA. Exercise therapy for claudication: should home-based exercise therapy be prescribed in clinical practice? J Vasc Nurs. 2015 Dec;33(4):143–9. doi: 10.1016/j.jvn.2015.06.001.
    1. Lane R, Ellis B, Watson L, Leng G. Exercise for intermittent claudication. Cochrane Database Syst Rev. 2014 Jul 18;(7):CD000990. doi: 10.1002/14651858.CD000990.pub3.
    1. McDermott MM. Exercise training for intermittent claudication. J Vasc Surg. 2017 Dec;66(5):1612–1620. doi: 10.1016/j.jvs.2017.05.111.
    1. McDermott MM, Ades P, Guralnik JM, Dyer A, Ferrucci L, Liu K, Nelson M, Lloyd-Jones D, Van Horn L, Garside D, Kibbe M, Domanchuk K, Stein JH, Liao Y, Tao H, Green D, Pearce WH, Schneider JR, McPherson D, Laing ST, McCarthy WJ, Shroff A, Criqui MH. Treadmill exercise and resistance training in patients with peripheral arterial disease with and without intermittent claudication: a randomized controlled trial. J Am Med Assoc. 2009 Jan 14;301(2):165–74. doi: 10.1001/jama.2008.962.
    1. Stewart KJ, Hiatt WR, Regensteiner JG, Hirsch AT. Exercise training for claudication. N Engl J Med. 2002 Dec 12;347(24):1941–51. doi: 10.1056/NEJMra021135.
    1. Hiatt WR, Armstrong EJ, Larson CJ, Brass EP. Pathogenesis of the limb manifestations and exercise limitations in peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1527–39. doi: 10.1161/CIRCRESAHA.116.303566.
    1. McDermott MM, Mehta S, Ahn H, Greenland P. Atherosclerotic risk factors are less intensively treated in patients with peripheral arterial disease than in patients with coronary artery disease. J Gen Intern Med. 1997 Apr;12(4):209–15. doi: 10.1007/s11606-006-5042-4.
    1. Welten GM, Schouten O, Hoeks SE, Chonchol M, Vidakovic R, van Domburg RT, Bax JJ, van Sambeek MR, Poldermans D. Long-term prognosis of patients with peripheral arterial disease: a comparison in patients with coronary artery disease. J Am Coll Cardiol. 2008 Apr 22;51(16):1588–96. doi: 10.1016/j.jacc.2007.11.077.
    1. Hageman D, Pesser N, Gommans LN, Willigendael EM, van Sambeek MR, Huijbers E, Snoeijen A, Scheltinga MR, Teijink JA. Limited adherence to peripheral arterial disease guidelines and suboptimal ankle brachial index reliability in Dutch primary care. Eur J Vasc Endovasc Surg. 2018 Jun;55(6):867–73. doi: 10.1016/j.ejvs.2018.02.011.
    1. Müller-Bühl U, Engeser P, Leutgeb R, Szecsenyi J. Low attendance of patients with intermittent claudication in a German community-based walking exercise program. Int Angiol. 2012 Jun;31(3):271–5.
    1. Duscha BD, Piner LW, Patel MP, Crawford LE, Jones WS, Patel MR, Kraus WE. Effects of a 12-week mHealth program on FunctionalCapacity and physical activity in patients with peripheralArtery disease. Am J Cardiol. 2018 Sep 01;122(5):879–84. doi: 10.1016/j.amjcard.2018.05.018.
    1. McDermott MM, Spring B, Berger JS, Treat-Jacobson D, Conte MS, Creager MA, Criqui MH, Ferrucci L, Gornik HL, Guralnik JM, Hahn EA, Henke P, Kibbe MR, Kohlman-Trighoff D, Li L, Lloyd-Jones D, McCarthy W, Polonsky TS, Skelly C, Tian L, Zhao L, Zhang D, Rejeski WJ. Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease: the HONOR randomized clinical trial. J Am Med Assoc. 2018 Dec 24;319(16):1665–76. doi: 10.1001/jama.2018.3275.
    1. Shalan A, Abdulrahman A, Habli I, Tew G, Thompson A. YORwalK: desiging a smartphone exercise application for people with intermittent claudication. Stud Health Technol Inform. 2018;247:311–5. doi: 10.3233/978-1-61499-852-5-311.
    1. Argent R, Daly A, Caulfield B. Patient involvement with home-based exercise programs: can connected health interventions influence adherence? JMIR Mhealth Uhealth. 2018 Mar 01;6(3):e47. doi: 10.2196/mhealth.8518.
    1. Burke LE, Ma J, Azar KM, Bennett GG, Peterson ED, Zheng Y, Riley W, Stephens J, Shah SH, Suffoletto B, Turan TN, Spring B, Steinberger J, Quinn CC, American Heart Association Publications Committee of the Council on EpidemiologyPrevention‚ Behavior Change Committee of the Council on Cardiometabolic Health‚ Council on CardiovascularStroke Nursing‚ Council on Functional GenomicsTranslational Biology‚ Council on Quality of CareOutcomes Research‚Stroke Council Current science on consumer use of mobile health for cardiovascular disease prevention: a scientific statement from the American Heart Association. Circulation. 2015 Sep 22;132(12):1157–213. doi: 10.1161/CIR.0000000000000232.
    1. Kostkova P. Grand challenges in digital health. Front Public Health. 2015;3:134. doi: 10.3389/fpubh.2015.00134. doi: 10.3389/fpubh.2015.00134.
    1. Reinecke H, Unrath M, Freisinger E, Bunzemeier H, Meyborg M, Lüders F, Gebauer K, Roeder N, Berger K, Malyar NM. Peripheral arterial disease and critical limb ischaemia: still poor outcomes and lack of guideline adherence. Eur Heart J. 2015 Apr 14;36(15):932–8. doi: 10.1093/eurheartj/ehv006.
    1. Perera S, Mody S, Woodman R, Studenski S. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006;54:9. doi: 10.1111/j.1532-5415.2006.00701.x.
    1. Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and validation of the user version of the Mobile Application Rating Scale (uMARS) JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.
    1. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 01;166(1):111–7. doi: 10.1164/ajrccm.166.1.at1102.
    1. Aboyans V, Ricco J, Bartelink M, Björck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Röther J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I, ESC Scientific Document Group 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS) Eur Heart J. 2018 Mar 01;39(9):763–816. doi: 10.1093/eurheartj/ehx095.
    1. Treat-Jacobson D, Lindquist RA, Witt DR, Kirk LN, Schorr EN, Bronas UG, Davey CS, Regensteiner JG. The PADQOL: development and validation of a PAD-specific quality of life questionnaire. Vasc Med. 2012 Dec;17(6):405–15. doi: 10.1177/1358863X12466708.
    1. Blankers M, Koeter MW, Schippers GM. Missing data approaches in eHealth research: simulation study and a tutorial for nonmathematically inclined researchers. J Med Internet Res. 2010 Dec;12(5):e54. doi: 10.2196/jmir.1448.
    1. Jolani S, Debray TP, Koffijberg H, van Buuren S, Moons KG. Imputation of systematically missing predictors in an individual participant data meta-analysis: a generalized approach using MICE. Statist. Med. 2015 Feb 09;34(11):1841–63. doi: 10.1002/sim.6451.
    1. Schafer JL, Graham JW. Missing data: our view of the state of the art. Psychol Methods. 2002 Jun;7(2):147–77.
    1. Barnes SA, Lindborg SR, Seaman JW. Multiple imputation techniques in small sample clinical trials. Stat Med. 2006 Jan 30;25(2):233–45. doi: 10.1002/sim.2231.
    1. Xu D, Zou L, Xing Y, Hou L, Wei Y, Zhang J, Qiao Y, Hu D, Xu Y, Li J, Ma Y. Diagnostic value of ankle-brachial index in peripheral arterial disease: a meta-analysis. Can J Cardiol. 2013 Apr;29(4):492–8. doi: 10.1016/j.cjca.2012.06.014.
    1. Elnady B, Saeed A. Peripheral vascular disease: the beneficial effect of exercise in peripheral vascular diseases based on clinical trials. Adv Exp Med Biol. 2017;1000:173–83. doi: 10.1007/978-981-10-4304-8_11.
    1. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918–30. doi: 10.1111/j.1475-6773.2005.00438.x.
    1. Hibbard JH, Greene J, Shi Y, Mittler J, Scanlon D. Taking the long view: how well do patient activation scores predict outcomes four years later? Med Care Res Rev. 2015 Jun;72(3):324–37. doi: 10.1177/1077558715573871.
    1. Sacks RM, Greene J, Hibbard J, Overton V, Parrotta CD. Does patient activation predict the course of type 2 diabetes? A longitudinal study. Patient Education and Counseling. 2017 Jul;100(7):1268–75. doi: 10.1016/j.pec.2017.01.014.
    1. King D, Greaves F, Exeter C, Darzi A. 'Gamification': influencing health behaviours with games. J R Soc Med. 2013 Mar;106(3):76–8. doi: 10.1177/0141076813480996.
    1. Cugelman B. Gamification: what it is and why it matters to digital health behavior change developers. JMIR Serious Games. 2013 Dec;1(1):e3. doi: 10.2196/games.3139.
    1. Muessig KE, Nekkanti M, Bauermeister J, Bull S, Hightow-Weidman LB. A systematic review of recent smartphone, internet and web 2.0 interventions to address the HIV continuum of care. Curr HIV/AIDS Rep. 2015 Mar;12(1):173–90. doi: 10.1007/s11904-014-0239-3.
    1. Lister C, West JH, Cannon B, Sax T, Brodegard D. Just a fad? Gamification in health and fitness apps. JMIR Serious Games. 2014 Aug;2(2):e9. doi: 10.2196/games.3413.
    1. Ferrara J. Games for persuasion: argumentation, procedurality, and the lie of gamification. Games Cult. 2013 Aug 27;8(4):289–304. doi: 10.1177/1555412013496891.
    1. Hoffmann A, Christmann CA, Bleser G. Gamification in stress management apps: a critical app review. JMIR Serious Games. 2017 Jun 07;5(2):e13. doi: 10.2196/games.7216.
    1. McDermott MM, Liu K, Guralnik JM, Criqui MH, Spring B, Tian L, Domanchuk K, Ferrucci L, Lloyd-Jones D, Kibbe M, Tao H, Zhao L, Liao Y, Rejeski WJ. Home-based walking exercise intervention in peripheral artery disease: a randomized clinical trial. J Am Med Assoc. 2013 Jul 03;310(1):57–65. doi: 10.1001/jama.2013.7231.

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