PMID- 28274907 OWN - NLM STAT- MEDLINE DCOM- 20170912 LR - 20200319 IS - 1438-8871 (Electronic) IS - 1439-4456 (Print) IS - 1438-8871 (Linking) VI - 19 IP - 3 DP - 2017 Mar 8 TI - Mobile Device-Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges. PG - e66 LID - 10.2196/jmir.6978 [doi] LID - e66 AB - BACKGROUND: 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. OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: The innovative mEDC has many merits and is well acceptable in supporting data collection and project management in a timely manner in clinical trial. CI - (c)Jing Zhang, Lei Sun, Yu Liu, Hongyi Wang, Ningling Sun, Puhong Zhang. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 08.03.2017. FAU - Zhang, Jing AU - Zhang J AUID- ORCID: 0000-0003-4727-3754 AD - The George Institute for Global Health at Peking University Health Science Center, Beijing, China. FAU - Sun, Lei AU - Sun L AUID- ORCID: 0000-0002-7969-4337 AD - The George Institute for Global Health at Peking University Health Science Center, Beijing, China. FAU - Liu, Yu AU - Liu Y AUID- ORCID: 0000-0003-1497-3949 AD - Beihang University, Beijing, China. FAU - Wang, Hongyi AU - Wang H AUID- ORCID: 0000-0003-1388-600X AD - The People's Hospital, Peking University, Beijing, China. FAU - Sun, Ningling AU - Sun N AD - The People's Hospital, Peking University, Beijing, China. FAU - Zhang, Puhong AU - Zhang P AUID- ORCID: 0000-0003-4610-9848 AD - The George Institute for Global Health at Peking University Health Science Center, Beijing, China. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20170308 PL - Canada TA - J Med Internet Res JT - Journal of medical Internet research JID - 100959882 RN - 0 (Antihypertensive Agents) RN - 0 (Benzimidazoles) RN - 0 (Benzoates) RN - 0J48LPH2TH (Hydrochlorothiazide) RN - U5SYW473RQ (Telmisartan) SB - IM MH - Adult MH - Antihypertensive Agents/therapeutic use MH - Benzimidazoles/therapeutic use MH - Benzoates/therapeutic use MH - *Cell Phone MH - Data Collection/*instrumentation/methods MH - Double-Blind Method MH - Electronic Data Processing/*methods MH - Female MH - Humans MH - Hydrochlorothiazide/therapeutic use MH - Hypertension/drug therapy MH - Male MH - Middle Aged MH - Randomized Controlled Trials as Topic/instrumentation/*methods MH - Telemedicine/*instrumentation/methods MH - Telmisartan PMC - PMC5362692 OTO - NOTNLM OT - clinical research OT - electronic data capture OT - mEDC OT - mhealth OT - mobile data capture OT - randomized controlled trial COIS- Conflicts of Interest: None declared. EDAT- 2017/03/10 06:00 MHDA- 2017/09/13 06:00 PMCR- 2017/03/08 CRDT- 2017/03/10 06:00 PHST- 2016/11/09 00:00 [received] PHST- 2017/02/10 00:00 [accepted] PHST- 2017/01/19 00:00 [revised] PHST- 2017/03/10 06:00 [entrez] PHST- 2017/03/10 06:00 [pubmed] PHST- 2017/09/13 06:00 [medline] PHST- 2017/03/08 00:00 [pmc-release] AID - v19i3e66 [pii] AID - 10.2196/jmir.6978 [doi] PST - epublish SO - J Med Internet Res. 2017 Mar 8;19(3):e66. doi: 10.2196/jmir.6978.