COMPUTERIZED SCHEDULING OF NICOTINE INHALER USE

尼古丁吸入器使用的计算机化安排

• 批准号: 2791491
• 负责人: NEAL RICHARD BOYD
• 金额: $ 10.53万
• 依托单位: PERSONAL IMPROVEMENT COMPUTER SYSTEMS
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-01-30 至 2000-01-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2791491
• 关键词: clinical research; computer program /software; computer system design /evaluation; drug administration rate /duration; drug delivery systems; human subject; human therapy evaluation; inhalation drug administration; nicotine; patient monitoring device; personal log /diary; questionnaires; relapse /recurrence; self care; smoking cessation

DESCRIPTION: The overall goal of this project is to develop a computerized program for scheduling the use of nicotine inhalers. The program will consist of a credit card size computer and a program guide. The computer will work by first assessing a baseline smoking rate then translating baseline rate into an inhaler scheduling algorithm. The computer will prompt users when and how long to puff on inhalers. After an initial fixed-dosing period, intervals between inhaler will be increased gradually until abstinence is achieved. The product will be suitable for use in either individual or group-based treatment. This Phase I project will include development of a first generation prototype system and a 12-week feasibility study with 100 smokers. Smokers will be randomly assigned to one of two conditions: computer scheduled inhaler use or ad lib inhaler use. Data on inhaler use, smoking, withdrawal symptoms, and ratings of satisfaction and usability will be collected. Criteria for feasibility will be statistically significant differences between groups for latency to smoking relapse and number of inhaler sessions per day during the first week of treatment. Data from the study and feedback from subjects will be used to guide further product development. During Phase II, a second generation prototype will be developed and evaluated in a large-scale clinical trial.

描述：本项目的总体目标是开发一种用于安排尼古丁吸入器使用的计算机化程序。 该计划将包括一个信用卡大小的计算机和程序指南。 计算机将首先评估基线吸烟率，然后将基线吸烟率转换为吸入器调度算法。 电脑会提示使用者何时使用吸入器以及使用多长时间。 在最初的固定给药期后，吸入器之间的间隔将逐渐增加，直至实现戒断。 该产品将适用于个人或团体治疗。 第一阶段项目将包括开发第一代原型系统和对100名吸烟者进行为期12周的可行性研究。 吸烟者将被随机分配到两种情况之一：计算机预定的吸入器使用或随意使用吸入器。 将收集关于吸入器使用、吸烟、戒断症状以及满意度和可用性评级的数据。 可行性标准将是治疗第一周期间吸烟复吸潜伏期和每天吸入器治疗次数的组间统计学显著差异。 研究数据和受试者反馈将用于指导进一步的产品开发。 在第二阶段，将开发第二代原型，并在大规模临床试验中进行评估。