%0 Journal Article
%@ 1438-8871
%I Gunther Eysenbach
%V 15
%N 4
%P e58
%T Tailored System to Deliver Behavioral Intervention and Manage Data in Randomized Trials
%A Zheng,Hua
%A Rosal,Milagros C
%A Oatis,Carol A
%A Li,Wenjun
%A Franklin,Patricia D
%+ Department of Orthopedics and Physical Rehabilitation, University of Massachusetts Medical School, ACC Building, AC-7037, 55 Lake Ave North, Worcester, MA, 01655, United States, 1 508 856 5748, Patricia.Franklin@umassmed.edu
%K structured behavioral intervention
%K intervention fidelity
%K clinical translational research
%K intervention delivery support system
%D 2013
%7 11.04.2013
%9 Original Paper
%J J Med Internet Res
%G English
%X Background: The integrity of behavioral intervention trials depends on consistent intervention delivery, and uniform, comprehensive process data collection. It can be challenging in practice due to complex human interactions involved. Objective: We sought to design a system to support the fidelity of intervention delivery and efficient capture of qualitative and quantitative process data for a telephone-delivered behavioral counseling intervention to increase physical activity and function after total knee replacement surgery. Methods: A tailored  system was designed to prompt the intervention coach in the delivery of a 5 step counseling protocol to support intervention fidelity across patients. System features included structured data components, automated data exchange functions, user-friendly data capture screens, and real-time surveillance reporting. The system structured the capture of patient goals and open-ended conversation. Results: The system recorded intervention process data from each of 12 sessions held with the 92 intervention patients. During the trial, 992 telephone sessions were conducted, and more than 97% (4816/4960) of intervention process data fields were completed in the system. The coach spent 5-10 minutes preparing for each counseling call using system-generated summaries of historical data and 10-15 minutes entering intervention process data following each telephone session. Conclusions: This intervention delivery system successfully supported the delivery of a structured behavioral counseling intervention and collection of intervention process data. It addressed the unique needs of clinical behavioral intervention trials, and had promising potential to facilitate high-fidelity translation of the intervention to broad clinical practice and Web-based multicenter clinical trials in the future. 
%M 23579207
%R 10.2196/jmir.2375
%U http://www.jmir.org/2013/4/e58/
%U https://doi.org/10.2196/jmir.2375
%U http://www.ncbi.nlm.nih.gov/pubmed/23579207