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临床试验/NCT03648203
NCT03648203已完成不适用

Technology Enabled Asthma Management System (TEAMS) Pilot Study

University of Rochester1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2018年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Acceptability of the TEAMS program for routine asthma management for patients as assessed by USE-Q at end of study

研究概览

简要总结

To evaluate feasibility, acceptability, safety, and preliminary efficacy of a novel patient-centered, technology-based intervention to improve asthma care in younger adult smartphone users.

The program, called TEAMS (Technology Enabled Asthma Management System), uses a combination of smartphone symptom monitoring, guideline-based medication protocols, nursing telemedicine home visits, and Electronic Medical Record (EMR) custom programming.

TEAMS is intended to augment primary asthma care as provided at the University of Rochester Medicine Clinic.

详细描述

Uncontrolled asthma is a tremendous burden to individuals and society. Asthma is one of the most common chronic health conditions globally, affecting more than 8.2% of adults in the U.S. Of adults with asthma in the U.S., 63% have persistent disease, and less than half are well-controlled. Uncontrolled asthma is associated with bothersome symptoms, economic burden, lost work time, and poorer quality of life. Direct and indirect costs are estimated at 56 billion dollars annually, with over 1.8 million ED visits, 439,000 hospitalizations, and 3,400 deaths in 2010 alone. Asthma morbidity and mortality is preventable. Correct use of controller medication and effective self-management alleviates symptoms, prevents exacerbations, and minimizes long-term damage to lungs associated with pulmonary remodeling. For these reasons, the National Heart Lung & Blood Institute (NHLBI) Guidelines recommend that all individuals with persistent asthma should take daily controller medications and receive consistent self-management training.

Currently, less than half of adults with persistent asthma take controller medication, and most do not self-manage their asthma effectively. Patient, provider, and systems-level factors contribute to this pattern. Patients fail to report symptoms, take medications inconsistently, and have insufficient resources (knowledge, time, transportation, money) to manage their disease.Providers in turn may lack familiarity with current best-practice guidelines, follow alternate prescribing practices, or spend insufficient time educating patients. Translation of asthma management knowledge into practice-based solutions is urgently needed. Many asthma interventions have been implemented within investigator-controlled settings. Problematically, few have been evaluated within or translated into the context of real world practice, and thus hold little benefit for the greater patient population. Limited ability to translate interventions from the bench to clinical settings suggests a need to develop and test interventions within the context in which they are intended to function. Effective real-world intervention to improve asthma outcomes requires development of a multifaceted program targeting key factors at the patient, provider, and systems level.

These include:

  • Patient tendency to ignore, forget, and not report symptoms;
  • Patient non-adherence to prescribed medication;
  • Patient lack of self-management skills and knowledge on how to self-manage effectively;
  • Barriers to consistent follow-up (access to care, burdens of time and transportation);
  • Provider non-adherence to National Guidelines for step-wise management of asthma; and
  • Provider underestimation of symptoms, and lack of time to provide thorough asthma education.

Therefore, the purpose of this study is to test feasibility, acceptability, safety, and preliminary efficacy of comprehensive Technology Enabled Asthma Management System (TEAMS), which addresses these critical factors, in order to improve asthma management and outcomes in younger adults.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient Subjects:
  • •Target population, Age 18-40; Age criteria may be expanded to include adults older than 40 as needed to meet recruitment needs
  • •With a diagnosis of intermittent or persistent asthma;
  • •Possessing an active smartphone with data plan or WiFi access;
  • •Able to communicate in English.
  • •Able to perform study-related functions
  • •Able to give informed consent.
  • •(All patient subjects will be counseled that telemedicine visits consume large amounts of data, and that use of Wifi is recommended. Patient subjects will be required to initial acknowledgement of this in the consent form. Currently however, many people have unlimited data plans, which may allow visits away from Wifi.)
  • •Provider Subjects:
  • •Primary care provider to patient subjects enrolled in the study
  • •Other Staff Subjects:
  • •Secretarial or Nursing staff at the clinic, having interaction with patient subjects or procedures.

排除标准

  • •Patient Subjects:
  • •Diagnosis of confounding respiratory or cardiac diseases (e.g. cystic fibrosis, sarcoidosis, COPD, CHF, Hypertension);
  • •Pregnancy
  • •Provider Subjects:
  • •Other Staff Subjects:

研究组 & 干预措施

TEAMS

Experimental

Routine asthma care, as provided in the University of Rochester Medical Center Medicine Clinic, will be augmented by three intervention components over a six-month pilot period : (1) Patient subject smartphone asthma monitoring; (2) Nursing telemedicine follow up (virtual home visits); (3) EMR custom programming to guide nursing assessment and management.

干预措施: Technology Enabled Asthma Management System (Behavioral)

结局指标

主要结局

Acceptability of the TEAMS program for routine asthma management for patients as assessed by USE-Q at end of study

时间窗: 6 months

The USE-Q (Usability Satisfaction and Ease of Use Questionnaire) is a 7 point Likert type scale that consists of 21 positive statements which the user rates on a 7-point Likert scale, with 0= strongly disagree to 7=strongly agree.

Change in asthma control from baseline to end of study at 6 months

时间窗: 6 months

Clinician-rated asthma control will be measured using the Asthma Control Questionnaire (ACQ) by Juniper. The instrument has 7 questions, each with a range of 0-6 with lower scores representing better asthma control. Total ACQ score is the average of the 7 individual items. A mean score of 0.75 (or less) on the ACQ has a positive predictive value of 0.85 for controlled asthma. A mean score of 1.5 or higher has a positive predictive value of 0.88 for uncontrolled asthma. Minimum important difference (MID) for the ACQ is a change score of 0.5.

Change in Forced Expiratory Volume over 1 second (FEV1) from baseline to end of study at 6 months

时间窗: 6 months

FEV1 will be measured using a digital peak flow meter with FEV1 capacity

Change in Asthma-related Quality of life from baseline to end of study at 6 months

时间窗: 6 months

Asthma-related quality of life will be measured using the Asthma Quality of Life Questionnaire (AQLQ(S)) by Juniper. The AQLQ measures physical and emotional impact of disease. There are 32 items with a range of 1-7 each, with higher scores representing better quality of life. (7=no impairment; 4= moderate impairment; 1=maximum impairment). The AQLQ consists of 4 domains. Domain scores are computed by averaging the scores of individual items which range from 7 (no impairment) to 1 (maximal impairment). The total AQLQ is computed by averaging the scores across all domains. MID for change in AQLQ total score is 0.5 total, and 0.5 per domain.

次要结局

  • Change in frequency of acute healthcare utilization from baseline to end of study at 6 month(6 months)
  • (Qualitative) Participant experiences with and perceptions of TEAMS program(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Mammen

Clinical Assistant Professor

University of Rochester

研究点 (1)

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