Published on in Vol 4, No 3 (2016): Jul-Sept

This is a member publication of Centre for Global eHealth Innovation, Toronto, ON, Canada

Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods

Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods

Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods

Journals

  1. de Korte E, Wiezer N, Janssen J, Vink P, Kraaij W. Evaluating an mHealth App for Health and Well-Being at Work: Mixed-Method Qualitative Study. JMIR mHealth and uHealth 2018;6(3):e72 View
  2. Adu M, Malabu U, Malau-Aduli A, Drovandi A, Malau-Aduli B. Efficacy and Acceptability of My Care Hub Mobile App to Support Self-Management in Australians with Type 1 or Type 2 Diabetes. International Journal of Environmental Research and Public Health 2020;17(7):2573 View
  3. Richardson P, Harrison L, Heathcote L, Rush G, Shear D, Lalloo C, Hood K, Wicksell R, Stinson J, Simons L. mHealth for pediatric chronic pain: state of the art and future directions. Expert Review of Neurotherapeutics 2020;20(11):1177 View
  4. Jahnel T, Schüz B. Partizipative Entwicklung von Digital-Public-Health-Anwendungen: Spannungsfeld zwischen Nutzer*innenperspektive und Evidenzbasierung. Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz 2020;63(2):153 View
  5. Liverpool S, Mota C, Sales C, Čuš A, Carletto S, Hancheva C, Sousa S, Cerón S, Moreno-Peral P, Pietrabissa G, Moltrecht B, Ulberg R, Ferreira N, Edbrooke-Childs J. Engaging Children and Young People in Digital Mental Health Interventions: Systematic Review of Modes of Delivery, Facilitators, and Barriers. Journal of Medical Internet Research 2020;22(6):e16317 View
  6. Morita P, Yeung M, Ferrone M, Taite A, Madeley C, Stevens Lavigne A, To T, Lougheed M, Gupta S, Day A, Cafazzo J, Licskai C. A Patient-Centered Mobile Health System That Supports Asthma Self-Management (breathe): Design, Development, and Utilization. JMIR mHealth and uHealth 2019;7(1):e10956 View
  7. Bradway M, Giordanengo A, Joakimsen R, Hansen A, Grøttland A, Hartvigsen G, Randine P, Årsand E. Measuring the Effects of Sharing Mobile Health Data During Diabetes Consultations: Protocol for a Mixed Method Study. JMIR Research Protocols 2020;9(2):e16657 View
  8. Crane D, Garnett C, Michie S, West R, Brown J. A smartphone app to reduce excessive alcohol consumption: Identifying the effectiveness of intervention components in a factorial randomised control trial. Scientific Reports 2018;8(1) View
  9. Livingston P, Heckel L, Orellana L, Ashley D, Ugalde A, Botti M, Pitson G, Woollett A, Chambers S, Parente P, Chirgwin J, Mihalopoulos C, Lavelle B, Sutton J, Phipps‐Nelson J, Krishnasamy M, Simons K, Heynsbergh N, Wickramasinghe N, White V. Outcomes of a randomized controlled trial assessing a smartphone A pplication to reduce unmet needs among people diagnosed with C anc E r (ACE). Cancer Medicine 2020;9(2):507 View
  10. Pelle T, Bevers K, van der Palen J, van den Hoogen F, van den Ende C. Effect of the dr. Bart application on healthcare use and clinical outcomes in people with osteoarthritis of the knee and/or hip in the Netherlands; a randomized controlled trial. Osteoarthritis and Cartilage 2020;28(4):418 View
  11. Dick S, O'Connor Y, Thompson M, O'Donoghue J, Hardy V, Wu T, O'Sullivan T, Chirambo G, Heavin C. Considerations for Improved Mobile Health Evaluation: Retrospective Qualitative Investigation. JMIR mHealth and uHealth 2020;8(1):e12424 View
  12. Davies E, Craven M, Martin J, Simons L. Proportionate methods for evaluating a simple digital mental health tool. Evidence Based Mental Health 2017;20(4):112 View
  13. Yang Y, Chen H, Qazi H, Morita P. Intervention and Evaluation of Mobile Health Technologies in Management of Patients Undergoing Chronic Dialysis: Scoping Review. JMIR mHealth and uHealth 2020;8(4):e15549 View
  14. Pasipanodya E, Kohli M, Fisher C, Moore D, Curtis B. Perceived risks and amelioration of harm in research using mobile technology to support antiretroviral therapy adherence in the context of methamphetamine use: a focus group study among minorities living with HIV. Harm Reduction Journal 2020;17(1) View
  15. Medina Riaño C, Cumbal Figueroa D, Nieto Ortíz L, Cano de la Cuerda R, Pinzón Bernal M. Aplicaciones móviles para lesión medular. Una revisión sistemática. Fisioterapia 2020;42(6):319 View
  16. Chehade M, Yadav L, Kopansky-Giles D, Merolli M, Palmer E, Jayatilaka A, Slater H. Innovations to improve access to musculoskeletal care. Best Practice & Research Clinical Rheumatology 2020;34(5):101559 View
  17. Slater H, Stinson J, Jordan J, Chua J, Low B, Lalloo C, Pham Q, Cafazzo J, Briggs A. Evaluation of Digital Technologies Tailored to Support Young People’s Self-Management of Musculoskeletal Pain: Mixed Methods Study. Journal of Medical Internet Research 2020;22(6):e18315 View
  18. Bally E, Cesuroglu T. Toward Integration of mHealth in Primary Care in the Netherlands: A Qualitative Analysis of Stakeholder Perspectives. Frontiers in Public Health 2020;7 View
  19. Goyal S, Nunn C, Rotondi M, Couperthwaite A, Reiser S, Simone A, Katzman D, Cafazzo J, Palmert M. A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. JMIR mHealth and uHealth 2017;5(6):e82 View
  20. Osborn J, Ajakaiye A, Cooksley T, Subbe C. Do mHealth applications improve clinical outcomes of patients with cancer? A critical appraisal of the peer-reviewed literature. Supportive Care in Cancer 2020;28(3):1469 View
  21. Münter K, Meaume S, Augustin M, Senet P, Kérihuel J. The reality of routine practice: a pooled data analysis on chronic wounds treated with TLC-NOSF wound dressings. Journal of Wound Care 2017;26(Sup2):S4 View
  22. Haberlin C, O’Dwyer T, Mockler D, Moran J, O’Donnell D, Broderick J. The use of eHealth to promote physical activity in cancer survivors: a systematic review. Supportive Care in Cancer 2018;26(10):3323 View
  23. Dhainaut J, Huot L, Bouchara Pomar V, Dubray C, Augé P, Barthélémy P, Belghiti J, Bureau S, Cassagnes J, Deblois S, Di Palma M, Dorsay G, Duchossoy L, Durand-Salmon F, Escudier T, Fiorini M, Franc S, Gelpi O, Laporte S, Lavallée E, Lethiec F, Meunier J, Peyret O, Samalin L, Vicaut E, de Saint-Exupéry E, Bouley A. Utilisation des objets connectés en recherche clinique. Therapies 2018;73(1):41 View
  24. Côté J, Rouleau G, Ramirez-Garcia M, Auger P, Thomas R, Leblanc J. Effectiveness of a Web-Based Intervention to Support Medication Adherence Among People Living With HIV: Web-Based Randomized Controlled Trial. JMIR Public Health and Surveillance 2020;6(2):e17733 View
  25. Moran J, Kelly G, Haberlin C, Mockler D, Broderick J. The use of eHealth to promote physical activity in people with mental health conditions: a systematic review. HRB Open Research 2018;1:5 View
  26. Puigdomenech Puig E, Robles N, Saigí-Rubió F, Zamora A, Moharra M, Paluzie G, Balfegó M, Cuatrecasas Cambra G, Garcia-Lorda P, Carrion C. Assessment of the Efficacy, Safety, and Effectiveness of Weight Control and Obesity Management Mobile Health Interventions: Systematic Review. JMIR mHealth and uHealth 2019;7(10):e12612 View
  27. Patel B, Thind A. Usability of Mobile Health Apps for Postoperative Care: Systematic Review. JMIR Perioperative Medicine 2020;3(2):e19099 View
  28. Marshall J, Dunstan D, Bartik W. Clinical or gimmickal: The use and effectiveness of mobile mental health apps for treating anxiety and depression. Australian & New Zealand Journal of Psychiatry 2020;54(1):20 View
  29. Pham Q, Shaw J, Morita P, Seto E, Stinson J, Cafazzo J. The Service of Research Analytics to Optimize Digital Health Evidence Generation: Multilevel Case Study. Journal of Medical Internet Research 2019;21(11):e14849 View
  30. Gründahl M, Deckert J, Hein G. Three Questions to Consider Before Applying Ecological Momentary Interventions (EMI) in Psychiatry. Frontiers in Psychiatry 2020;11 View
  31. Romeo A, Edney S, Plotnikoff R, Curtis R, Ryan J, Sanders I, Crozier A, Maher C. Can Smartphone Apps Increase Physical Activity? Systematic Review and Meta-Analysis. Journal of Medical Internet Research 2019;21(3):e12053 View
  32. Holmen H, Riiser K, Winger A. Home-Based Pediatric Palliative Care and Electronic Health: Systematic Mixed Methods Review. Journal of Medical Internet Research 2020;22(2):e16248 View
  33. Connolly S, Hogan T, Shimada S, Miller C. Leveraging Implementation Science to Understand Factors Influencing Sustained Use of Mental Health Apps: a Narrative Review. Journal of Technology in Behavioral Science 2021;6(2):184 View
  34. Slater H, Campbell J, Stinson J, Burley M, Briggs A. End User and Implementer Experiences of mHealth Technologies for Noncommunicable Chronic Disease Management in Young Adults: Systematic Review. Journal of Medical Internet Research 2017;19(12):e406 View
  35. Cafazzo J. A Digital-First Model of Diabetes Care. Diabetes Technology & Therapeutics 2019;21(S2):S2-52 View
  36. Escobar-Viera C, Zhou Z, Morano J, Lucero R, Lieb S, McIntosh S, Clauson K, Cook R. The Florida Mobile Health Adherence Project for People Living With HIV (FL-mAPP): Longitudinal Assessment of Feasibility, Acceptability, and Clinical Outcomes. JMIR mHealth and uHealth 2020;8(1):e14557 View
  37. Moran J, Kelly G, Haberlin C, Mockler D, Broderick J. The use of eHealth to promote physical activity in people with mental health conditions: a systematic review. HRB Open Research 2018;1:5 View
  38. Pham Q, Graham G, Lalloo C, Morita P, Seto E, Stinson J, Cafazzo J. An Analytics Platform to Evaluate Effective Engagement With Pediatric Mobile Health Apps: Design, Development, and Formative Evaluation. JMIR mHealth and uHealth 2018;6(12):e11447 View
  39. Garnett C, Michie S, West R, Brown J. Updating the evidence on the effectiveness of the alcohol reduction app, Drink Less: using Bayes factors to analyse trial datasets supplemented with extended recruitment. F1000Research 2019;8:114 View
  40. Kao C, Liebovitz D. Consumer Mobile Health Apps: Current State, Barriers, and Future Directions. PM&R 2017;9:S106 View
  41. Rowland S, Fitzgerald J, Holme T, Powell J, McGregor A. What is the clinical value of mHealth for patients?. npj Digital Medicine 2020;3(1) View
  42. Naderi H, Etminani K. What Android mHealth Apps in Iranian App Store ‘Cafebazaar’ Have More Chance of Download. Shiraz E-Medical Journal 2018;In Press(In Press) View
  43. Wyatt J. How can clinicians, specialty societies and others evaluate and improve the quality of apps for patient use?. BMC Medicine 2018;16(1) View
  44. Bradway M, Gabarron E, Johansen M, Zanaboni P, Jardim P, Joakimsen R, Pape-Haugaard L, Årsand E. Methods and Measures Used to Evaluate Patient-Operated Mobile Health Interventions: Scoping Literature Review. JMIR mHealth and uHealth 2020;8(4):e16814 View
  45. Glattacker M, Boeker M, Anger R, Reichenbach F, Tassoni A, Bredenkamp R, Giesler J. Evaluation of a Mobile Phone App for Patients With Pollen-Related Allergic Rhinitis: Prospective Longitudinal Field Study. JMIR mHealth and uHealth 2020;8(4):e15514 View
  46. Amato M, Papandonatos G, Cha S, Wang X, Zhao K, Cohn A, Pearson J, Graham A. Inferring Smoking Status from User Generated Content in an Online Cessation Community. Nicotine & Tobacco Research 2019;21(2):205 View
  47. Dhainaut J, Huot L, Pomar V, Dubray C, Augé P, Barthélémy P, Belghiti J, Bureau S, Cassagnes J, Deblois S, Di Palma M, Dorsay G, Duchossoy L, Durand-Salmon F, Escudier T, Fiorini M, Franc S, Gelpi O, Laporte S, Lavallée E, Lethiec F, Meunier J, Peyret O, Samalin L, Vicaut E, de Saint-Exupéry E, Bouley A. Using connected objects in clinical research. Therapies 2018;73(1):53 View
  48. Moran J, Kelly G, Haberlin C, Mockler D, Broderick J. The use of eHealth to promote physical activity in patients with mental health conditions: a systematic review. HRB Open Research 2018;1:5 View
  49. McCallum C, Rooksby J, Gray C. Evaluating the Impact of Physical Activity Apps and Wearables: Interdisciplinary Review. JMIR mHealth and uHealth 2018;6(3):e58 View
  50. Lancaster K, Abuzour A, Khaira M, Mathers A, Chan A, Bui V, Lok A, Thabane L, Dolovich L. The Use and Effects of Electronic Health Tools for Patient Self-Monitoring and Reporting of Outcomes Following Medication Use: Systematic Review. Journal of Medical Internet Research 2018;20(12):e294 View
  51. Byambasuren O, Sanders S, Beller E, Glasziou P. Prescribable mHealth apps identified from an overview of systematic reviews. npj Digital Medicine 2018;1(1) View
  52. Hussain-Shamsy N, Shah A, Vigod S, Zaheer J, Seto E. Mobile Health for Perinatal Depression and Anxiety: Scoping Review. Journal of Medical Internet Research 2020;22(4):e17011 View
  53. Slater H, Briggs A, Stinson J, Campbell J. End user and implementer experiences of mHealth technologies for noncommunicable chronic disease management in young adults: a qualitative systematic review protocol. JBI Database of Systematic Reviews and Implementation Reports 2017;15(8):2047 View
  54. Dick S, O’Connor Y, Heavin C. Approaches to Mobile Health Evaluation: A Comparative Study. Information Systems Management 2020;37(1):75 View
  55. Pfammatter A, Marchese S, Pellegrini C, Daly E, Davidson M, Spring B. Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research. JMIR Formative Research 2020;4(5):e16297 View
  56. Sucala M, Nilsen W, Muench F. Building partnerships: a pilot study of stakeholders’ attitudes on technology disruption in behavioral health delivery and research. Translational Behavioral Medicine 2017;7(4):854 View
  57. Garnett C, Michie S, West R, Brown J. Updating the evidence on the effectiveness of the alcohol reduction app, Drink Less: using Bayes factors to analyse trial datasets supplemented with extended recruitment. F1000Research 2019;8:114 View
  58. Lalloo C, Harris L, Hundert A, Berard R, Cafazzo J, Connelly M, Feldman B, Houghton K, Huber A, Laxer R, Luca N, Schmeling H, Spiegel L, Tucker L, Pham Q, Davies-Chalmers C, Stinson J. The iCanCope pain self-management application for adolescents with juvenile idiopathic arthritis: a pilot randomized controlled trial. Rheumatology 2021;60(1):196 View
  59. Schiel R, Bambauer R, Steveling A. Technology in Diabetes Treatment: Update and Future. Artificial Organs 2018;42(11):1017 View
  60. Bird M, Strachan P. Complexity science education for clinical nurse researchers. Journal of Professional Nursing 2020;36(2):50 View
  61. Pham Q, Cafazzo J, Feifer A. Adoption, Acceptability, and Effectiveness of a Mobile Health App for Personalized Prostate Cancer Survivorship Care: Protocol for a Realist Case Study of the Ned App. JMIR Research Protocols 2017;6(10):e197 View
  62. D'Antrassi P, Prenassi M, Rossi L, Ferrucci R, Barbieri S, Priori A, Marceglia S. Personally Collected Health Data for Precision Medicine and Longitudinal Research. Frontiers in Medicine 2019;6 View
  63. Lentferink A, Oldenhuis H, de Groot M, Polstra L, Velthuijsen H, van Gemert-Pijnen J. Key Components in eHealth Interventions Combining Self-Tracking and Persuasive eCoaching to Promote a Healthier Lifestyle: A Scoping Review. Journal of Medical Internet Research 2017;19(8):e277 View
  64. Lalloo C, Pham Q, Cafazzo J, Stephenson E, Stinson J. A ResearchKit app to deliver paediatric electronic consent: Protocol of an observational study in adolescents with arthritis. Contemporary Clinical Trials Communications 2020;17:100525 View
  65. Vandelanotte C, Duncan M, Kolt G, Caperchione C, Savage T, Van Itallie A, Oldmeadow C, Alley S, Tague R, Maeder A, Rosenkranz R, Mummery W. More real-world trials are needed to establish if web-based physical activity interventions are effective. British Journal of Sports Medicine 2019;53(24):1553 View
  66. Lattie E, Adkins E, Winquist N, Stiles-Shields C, Wafford Q, Graham A. Digital Mental Health Interventions for Depression, Anxiety, and Enhancement of Psychological Well-Being Among College Students: Systematic Review. Journal of Medical Internet Research 2019;21(7):e12869 View
  67. Speerin R, Needs C, Chua J, Woodhouse L, Nordin M, McGlasson R, Briggs A. Implementing models of care for musculoskeletal conditions in health systems to support value-based care. Best Practice & Research Clinical Rheumatology 2020;34(5):101548 View
  68. Stricker R, Fesler M. <p>Flattening the Risk: Pre-Exposure Prophylaxis for COVID-19</p>. Infection and Drug Resistance 2020;Volume 13:3689 View
  69. Tarricone R, Petracca F, Ciani O, Cucciniello M. Distinguishing features in the assessment of mHealth apps. Expert Review of Pharmacoeconomics & Outcomes Research 2021:1 View
  70. Alfonsi J, Choi E, Arshad T, Sammott S, Pais V, Nguyen C, Maguire B, Stinson J, Palmert M. Carbohydrate Counting App Using Image Recognition for Youth With Type 1 Diabetes: Pilot Randomized Control Trial. JMIR mHealth and uHealth 2020;8(10):e22074 View
  71. van Kessel K, Babbage D, Kersten P, Drown J, Sezier A, Thomas P, Thomas S. Design considerations for a multiple sclerosis fatigue mobile app MS Energize: A pragmatic iterative approach using usability testing and resonance checks. Internet Interventions 2021;24:100371 View
  72. Zeleke A, Naziyok T, Fritz F, Christianson L, Röhrig R. Data Quality and Cost-effectiveness Analyses of Electronic and Paper-Based Interviewer-Administered Public Health Surveys: Systematic Review. Journal of Medical Internet Research 2021;23(1):e21382 View
  73. Kepper M, Walsh-Bailey C, Staiano A, Fowler L, Gacad A, Blackwood A, Fowler S, Kelley M. Health Information Technology Use Among Healthcare Providers Treating Children and Adolescents With Obesity: a Systematic Review. Current Epidemiology Reports 2021 View
  74. Logan D, Simons L, Caruso T, Gold J, Greenleaf W, Griffin A, King C, Menendez M, Olbrecht V, Rodriguez S, Silvia M, Stinson J, Wang E, Williams S, Wilson L. Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management. Journal of Medical Internet Research 2021;23(4):e25916 View
  75. Cheng V. Recommendations for Implementing Gamification for Mental Health and Wellbeing. Frontiers in Psychology 2020;11 View
  76. Schwartz S, Wildenhaus K, Bucher A, Byrd B. Digital Twins and the Emerging Science of Self: Implications for Digital Health Experience Design and “Small” Data. Frontiers in Computer Science 2020;2 View
  77. Gensorowsky D, Lampe D, Hasemann L, Düvel J, Greiner W. „Alternative Studiendesigns“ zur Bewertung digitaler Gesundheitsanwendungen – eine echte Alternative?. Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen 2021;161:33 View
  78. French D, McKillop D, Stewart E. Personal finance apps and low‐income households. Strategic Change 2021;30(4):367 View
  79. Domin A, Spruijt-Metz D, Theisen D, Ouzzahra Y, Vögele C. Smartphone-Based Interventions for Physical Activity Promotion: Scoping Review of the Evidence Over the Last 10 Years. JMIR mHealth and uHealth 2021;9(7):e24308 View
  80. Chow J, Elizabeth Pathak L, Yeh S. Using mobile apps in social work behavioral health care service: The case for China. International Social Work 2021:002087282110319 View

Books/Policy Documents

  1. Hamilton F, Murray E. Encyclopedia of Behavioral Medicine. View
  2. Idris A, Heupel W. Digitale Transformation von Dienstleistungen im Gesundheitswesen VII. View
  3. Cerrato P, Halamka J. The Transformative Power of Mobile Medicine. View
  4. . Connected Healthcare for the Citizen. View
  5. Searchfield G, Zhang J, Biswas R, De Ridder D, Deutsch B, Hall Hébert S, Hall D, Kleinjung T, Kleinstäuber M, Langguth B, Lopez-Escamez J, Maslin M, Mazurek B, Piccirillo J, Salvi R, Schlee W, Shulman A, Shore S, Szczepek A, Smith P, Theodoroff S, Vajsakovic D, Weise C, Zheng Y. . View
  6. Hamilton F, Murray E. Encyclopedia of Behavioral Medicine. View