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View (E18) Saskia Puijk-Hekman, Betsie Van Gaal, Sebastian Bredie, Maria Nijhuis-Van Der Sanden, Sandra Van Dulmen

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View (E18) Saskia Puijk-Hekman, Betsie Van Gaal, Sebastian Bredie, Maria Nijhuis-Van Der Sanden, Sandra Van Dulmen JMIR Research Protocols Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results Volume 6 (2017), Issue 2 ISSN: 1929-0748 Contents Original Papers Self-Management Support Program for Patients With Cardiovascular Diseases: User-Centered Development of the Tailored, Web-Based Program Vascular View (e18) Saskia Puijk-Hekman, Betsie van Gaal, Sebastian Bredie, Maria Nijhuis-van der Sanden, Sandra van Dulmen. 3 A Prospective, Multicenter, Single-Blind Study Assessing Indices of SNAP II Versus BIS VISTA on Surgical Patients Undergoing General Anesthesia (e15) Sergio Bergese, Alberto Uribe, Erika Puente, R-Jay Marcus, Randall Krohn, Steven Docsa, Roy Soto, Keith Candiotti. 80 Feasibility of Ecological Momentary Assessment of Daily Sexting and Substance Use Among Young Adult African American Gay and Bisexual Men: A Pilot Study (e9) Sabrina Smiley, Hoda Elmasry, Monica Webb Hooper, Raymond Niaura, Alison Hamilton, Norweeta Milburn. 127 Involving Children With Cancer in Health Promotive Research: A Case Study Describing Why, What, and How (e19) Jens Nygren, Susanne Lindberg, Pontus Wärnestål, Petra Svedberg. 162 Protocols Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults (e14) Jane Alcorn, Susan Whiting, Navita Viveky, Yunyun Di, Kerry Mansell, Sharyle Fowler, Lilian Thorpe, Ahmed Almousa, Pui Cheng, Jennifer Jones, Jennifer Billinsky, Thomas Hadjistavropoulos. 16 Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial (e20) Pierre-Anthony Leake, Patrick Toppin, Marvin Reid, Joseph Plummer, Patrick Roberts, Hyacinth Harding-Goldson, Michael McFarlane. 27 VESPRO: An Individual Patient Data Prospective Meta-Analysis of Selective Internal Radiation Therapy Versus Sorafenib for Advanced, Locally Advanced, or Recurrent Hepatocellular Carcinoma of the SARAH and SIRveNIB Trials (e17) Val Gebski, Emma Gibbs, Mihir Gandhi, Gilles Chatellier, Aurelia Dinut, Helena Pereira, Pierce Chow, Valérie Vilgrain. 36 Statins and Fibrates for Diabetic Retinopathy: Protocol for a Systematic Review (e30) Vania Mozetic, Carolina Freitas, Rachel Riera. 51 JMIR Research Protocols 2017 | vol. 6 | iss. 2 | p.1 XSL·FO RenderX Rationale and Design of a Genetic Study on Cardiometabolic Risk Factors: Protocol for the Tehran Cardiometabolic Genetic Study (TCGS) (e28) Maryam Daneshpour, Mohammad-Sadegh Fallah, Bahareh Sedaghati-Khayat, Kamran Guity, Davood Khalili, Mehdi Hedayati, Ahmad Ebrahimi, Farhad Hajsheikholeslami, Parvin Mirmiran, Fahimeh Ramezani Tehrani, Amir-Abbas Momenan, Arash Ghanbarian, Atieh Amouzegar, Parisa Amiri, Fereidoun Azizi. 58 Feasibility of Implementing a Patient-Centered Postoperative Wound Monitoring Program Using Smartphone Images: A Pilot Protocol (e26) Sara Fernandes-Taylor, Rebecca Gunter, Kyla Bennett, Lola Awoyinka, Shahrose Rahman, Caprice Greenberg, K Kent. 68 Irreversible Electroporation for the Ablation of Renal Cell Carcinoma: A Prospective, Human, In Vivo Study Protocol (IDEAL Phase 2b) (e21) Mara Buijs, Krijn van Lienden, Peter Wagstaff, Matthijs Scheltema, Daniel de Bruin, Patricia Zondervan, Otto van Delden, Ton van Leeuwen, Jean de la Rosette, M Laguna. 87 Epigenetic Alterations and Exposure to Air Pollutants: Protocol for a Birth Cohort Study to Evaluate the Association Between Adverse Birth Outcomes and Global DNA Methylation (e29) Zhila Maghbooli, Arash Hossein-Nezhad, Majid Ramezani, Syamak Moattari. 110 Delirium After Mechanical Ventilation in Intensive Care Units:The Cognitive and Psychosocial Assessment (CAPA) Study Protocol (e31) Daniella Bulic, Michael Bennett, Helen Rodgers, Mary Nourse, Patrick Rubie, Jeffrey Looi, Frank Van Haren. 118 Co-creating and Evaluating a Web-app Mapping Real-World Health Care Services for Students: The servi-Share Protocol (e24) Ilaria Montagni, Emmanuel Langlois, Jérôme Wittwer, Christophe Tzourio. 138 Dance for Adults With FibromyalgiaÐWhat Do We Know About It? Protocol for a Scoping Review (e25) Julia Bidonde, Catherine Boden, Angela Busch, Suelen Goes, Soo Kim, Emily Knight. 147 Viewpoint For You and Your Baby (4YYB): Adapting the Centers for Disease Control and Prevention's Text4Baby Program for Saudi Arabia (e23) Soha Bahanshal, Steven Coughlin, Benyuan Liu. 99 Short Paper Online Dissemination Strategies of a Canada Research Chair: Overview and Lessons Learned (e27) Jessica Hébert, Hubert Robitaille, Stéphane Turcotte, France Légaré. 156 JMIR Research Protocols 2017 | vol. 6 | iss. 2 | p.2 XSL·FO RenderX JMIR RESEARCH PROTOCOLS Puijk-Hekman et al Original Paper Self-Management Support Program for Patients With Cardiovascular Diseases: User-Centered Development of the Tailored, Web-Based Program Vascular View Saskia Puijk-Hekman1, MSc; Betsie GI van Gaal1,2, PhD; Sebastian JH Bredie3, MD, PhD; Maria WG Nijhuis-van der Sanden1, PhD; Sandra van Dulmen4,5,6, PhD 1Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare, Nijmegen, Netherlands 2Institute of Nursing, HAN University of Applied Sciences, Nijmegen, Netherlands 3Radboud university medical center, Department of General Internal Medicine, Nijmegen, Netherlands 4Radboud university medical center, Radboud Institute for Health Sciences, Department of Primary and Community Care, Nijmegen, Netherlands 5NIVEL (Netherlands institute for health services research), Utrecht, Netherlands 6Faculty of Health Sciences, University College of Southeast Norway, Drammen, Norway Corresponding Author: Saskia Puijk-Hekman, MSc Radboud university medical center Radboud Institute for Health Sciences IQ healthcare PO Box 9101 Nijmegen, 6500 HB Netherlands Phone: 31 24 36 55 673 Fax: 31 24 35 40 166 Email: [email protected] Abstract Background: In addition to medical intervention and counseling, patients with cardiovascular disease (CVD) need to manage their disease and its consequences by themselves in daily life. Objective: The aim of this paper is to describe the development of ªVascular View,º a comprehensive, multi-component, tailored, Web-based, self-management support program for patients with CVD, and how this program will be tested in an early randomized controlled trial (RCT). Methods: The Vascular View program was systematically developed in collaboration with an expert group of 6 patients, and separately with a group of 6 health professionals (medical, nursing, and allied health care professionals), according to the following steps of the intervention mapping (IM) framework: (1) conducting a needs assessment; (2) creating matrices of change objectives; (3) selecting theory-based intervention methods and practical applications; (4) organizing methods and applications into an intervention program; (5) planning the adaption, implementation, and sustainability of the program, and (6) generating an evaluation plan. Results: The needs assessment (Step 1) identified 9 general health problems and 8 determinants (knowledge, awareness, attitude, self-efficacy, subjective norm, intention, risk perception, and habits) of self-managing CVD. By defining performance and change objectives (Step 2), 6 topics were distinguished and incorporated into the courses included in Vascular View (Steps 3 and 4): (1) Coping With CVD and its Consequences; (2) Setting Boundaries in Daily Life; (3) Lifestyle (general and tobacco and harmful alcohol use); (4) Healthy Nutrition; (5) Being Physically Active in a Healthy Way; and (6) Interaction With Health Professionals. These courses were based on behavioral change techniques (BCTs) (eg, self-monitoring of behavior, modeling, re-evaluation of outcomes), which were incorporated in the courses through general written information: quotes from and videos of patients with CVD as role models and personalized feedback, diaries, and exercises. The adoption and implementation plan (Step 5) was set up in collaboration with the members of the two expert groups and consisted of a written and digital instruction manual, a flyer, bimonthly newsletters, and reminders by email and telephone to (re-)visit the program. The potential effectiveness of Vascular View will be evaluated (Step 6) in an early RCT to gain insight into relevant outcome variables and related effect sizes, and a process evaluation to identify intervention fidelity, potential working mechanisms, user statistics, and/or satisfaction. http://www.researchprotocols.org/2017/2/e18/ JMIR Res Protoc 2017 | vol. 6 | iss. 2 | e18 | p.3 (page number not for citation purposes) XSL·FO RenderX JMIR RESEARCH PROTOCOLS Puijk-Hekman et al Conclusion: A comprehensive, multi-component, tailored, Web-based, self-management support program and an early RCT were developed in order to empower patients to self-manage their CVD. Trial Registration: Nederlands Trial Register NTR5412; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5412 (Archived by WebCite at http://www.webcitation.org/6jeUFVj40) (JMIR Res Protoc 2017;6(2):e18) doi:10.2196/resprot.6352 KEYWORDS intervention mapping; eHealth; self-management; cardiovascular diseases; tailoring; nursing care; chronic secondary care; outpatients; early RCT patient's self-management skills, for which Web-based programs Introduction are expected to be helpful [12]. However, Web-based programs Cardio vascular disease (CVD) is the leading cause of death demonstrate varied and inconsistent effectiveness due to design worldwide [1]. In 2012, 17.5 million people died of CVD, within limitations and lack of power [12]. Only a few studies
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