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Technology Enabled Asthma Management System (TEAMS) Pilot Study (TEAMS)

2020年3月17日 更新者:Jennifer Mammen、University of Rochester

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.

調査の概要

詳細な説明

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.

The specific aims of the study are:

Aim 1: To evaluate feasibility and acceptability of TEAMS. • Hypothesis A: TEAMS will be feasible for and acceptable to young adults and primary care providers for routine management of asthma, as measured by USE-Q survey data, frequency of symptom self-monitoring and at completion of least one virtual visit, and post-intervention qualitative interviews.

Aim 2: To evaluate safety and preliminary efficacy of TEAMS.

• Hypothesis B: TEAMS will be associated with improved asthma outcomes following intervention, as measured by primary outcomes of: (a) increased asthma control, pulmonary function, quality of life, and secondary outcomes of (b) decreased office visits for asthma exacerbations, asthma-related ED visits, and hospitalizations.

Aim 3: To optimize TEAMS intervention components based on quantitative survey data and qualitative interviews, including patient subject and clinic staff perspectives.

2. STUDY DESIGN

2.1. Overview TEAMS is a multi-level, theoretically-based intervention that capitalizes on patient-provider-nurse partnerships and use of technology to improve the quality and convenience of routine asthma care. TEAMS has Social Cognitive Theory underpinnings. It targets person level factors associated with asthma outcomes (individual knowledge, norms, attitudes, illness beliefs and self-efficacy), self-management behaviors (prevention, monitoring, management and communication of symptoms), and environmental factors (access to care, delivery of guideline-based care).

The overarching goal of TEAMS is to improve asthma outcomes by leveraging capabilities of existing technology (smartphone, telemedicine, electronic medical record). TEAMS will operate in conjunction with standard care in the Medicine Clinic.

研究の種類

介入

入学 (実際)

44

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • New York
      • Rochester、New York、アメリカ、14642
        • University of Rochester

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

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.

Exclusion Criteria:

Patient Subjects:

  • Diagnosis of confounding respiratory or cardiac diseases (e.g. cystic fibrosis, sarcoidosis, COPD, CHF, Hypertension);
  • Pregnancy

Provider Subjects:

• None

Other Staff Subjects:

• None

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:TEAMS
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.
See description of arm
他の名前:
  • チーム

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Acceptability of the TEAMS program for routine asthma management for patients as assessed by USE-Q at end of study
時間枠: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.
6 months
Change in asthma control from baseline to end of study at 6 months
時間枠: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.
6 months
Change in Forced Expiratory Volume over 1 second (FEV1) from baseline to end of study at 6 months
時間枠:6 months
FEV1 will be measured using a digital peak flow meter with FEV1 capacity
6 months
Change in Asthma-related Quality of life from baseline to end of study at 6 months
時間枠: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.
6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in frequency of acute healthcare utilization from baseline to end of study at 6 month
時間枠:6 months
Counts (frequency) of asthma-related acute healthcare visits will be extracted from the electronic medical record (ED visits and hospitalizations related to asthma) and will be compared for the equivalent 6 months prior to intervention and the 6 months of intervention
6 months
(Qualitative) Participant experiences with and perceptions of TEAMS program
時間枠:6 months
Assessment of participants experiences with and perceptions of the TEAMS program, as assessed by in-depth semi-structured qualitative interview (1:1).
6 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Tiffany Gommel, MS, CIM, CIP、University of Rochester

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年2月15日

一次修了 (実際)

2020年2月5日

研究の完了 (実際)

2020年3月17日

試験登録日

最初に提出

2018年7月31日

QC基準を満たした最初の提出物

2018年8月23日

最初の投稿 (実際)

2018年8月27日

学習記録の更新

投稿された最後の更新 (実際)

2020年3月18日

QC基準を満たした最後の更新が送信されました

2020年3月17日

最終確認日

2020年3月1日

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