title: Mobile Device-Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges.
abstract: Electronic data capture (EDC) systems have been widely used in clinical research, but mobile device-based electronic data capture (mEDC) system has not been well evaluated.
  
  
  
  The aim of our study was to evaluate the feasibility, advantages, and challenges of mEDC in data collection, project management, and telemonitoring in a randomized controlled trial (RCT).
  
  
  
  We developed an mEDC to support an RCT called "Telmisartan and Hydrochlorothiazide Antihypertensive Treatment (THAT)" study, which was a multicenter, double-blinded, RCT, with the purpose of comparing the efficacy of telmisartan and hydrochlorothiazide (HCTZ) monotherapy in high-sodium-intake patients with mild to moderate hypertension during a 60 days follow-up. Semistructured interviews were conducted during and after the trial to evaluate the feasibility, advantage, and challenge of mEDC. Nvivo version 9.0 (QSR International) was used to analyze records of interviews, and a thematic framework method was used to obtain outcomes.
  
  
  
  The mEDC was successfully used to support the data collection and project management in all the 14 study hospitals. A total of 1333 patients were recruited with support of mEDC, of whom 1037 successfully completed all 4 visits. Across all visits, the average time needed for 141 questions per patient was 53 min, which were acceptable to both doctors and patients. All the interviewees, including 24 doctors, 53 patients, 1 clinical research associate (CRA), 1 project manager (PM), and 1 data manager (DM), expressed their satisfaction to nearly all the functions of the innovative mEDC in randomization, data collection, project management, quality control, and remote monitoring in real time. The average satisfaction score was 9.2 (scale, 0-10). The biggest challenge came from the stability of the mobile or Wi-Fi signal although it was not a problem in THAT study.
  
  
  
  The innovative mEDC has many merits and is well acceptable in supporting data collection and project management in a timely manner in clinical trial.
authors.affiliation: The George Institute for Global Health at Peking University Health Science Center, Beijing, China.
authors.forename: Jing
authors.identifier: 0000-0003-4727-3754
authors.initials: J
authors.lastname: Zhang
authors.affiliation: The George Institute for Global Health at Peking University Health Science Center, Beijing, China.
authors.forename: Lei
authors.identifier: 0000-0002-7969-4337
authors.initials: L
authors.lastname: Sun
authors.affiliation: Beihang University, Beijing, China.
authors.forename: Yu
authors.identifier: 0000-0003-1497-3949
authors.initials: Y
authors.lastname: Liu
authors.affiliation: The People's Hospital, Peking University, Beijing, China.
authors.forename: Hongyi
authors.identifier: 0000-0003-1388-600X
authors.initials: H
authors.lastname: Wang
authors.affiliation: The People's Hospital, Peking University, Beijing, China.
authors.forename: Ningling
authors.initials: N
authors.lastname: Sun
authors.affiliation: The George Institute for Global Health at Peking University Health Science Center, Beijing, China.
authors.forename: Puhong
authors.identifier: 0000-0003-4610-9848
authors.initials: P
authors.lastname: Zhang
mesh_terms: D000328:Adult; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001562:Benzimidazoles / Q000627:therapeutic use; D001565:Benzoates / Q000627:therapeutic use; D040421:Cell Phone; D003625:Data Collection / Q000295:instrumentation* / Q000379:methods; D004311:Double-Blind Method; D001330:Electronic Data Processing / Q000379:methods*; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use; D006973:Hypertension / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000295:instrumentation / Q000379:methods*; D017216:Telemedicine / Q000295:instrumentation* / Q000379:methods; D000077333:Telmisartan
chemical_list: D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001565:Benzoates; D006852:Hydrochlorothiazide; D000077333:Telmisartan
keywords: clinical research; electronic data capture; mEDC; mhealth; mobile data capture; randomized controlled trial