PackHealth: Asthma Engagement Tool
Assessing the Impact of a Patient-Clinician Engagement Tool on Patient Reported Outcomes and Engagement in Asthma
연구 개요
상세 설명
Patient engagement is a critical part of improving patient care and outcomes. Current patient engagement strategies only focus on the patient-physician interaction and have been shown to be ineffective.
The need for a comprehensive approach to patient engagement is no different among patients with asthma as it is in any other chronic condition. Patients with asthma must make complicated health decisions daily that impact their social and occupational activities, quality of life, and treatment adherence. Obtaining, communicating, processing, and understanding non- biased health information are crucial in making appropriate and informed treatment decisions.
Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care. Each Pack draws on the science of change management and patient activation and contains three categories of materials
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
North Carolina
-
Durham, North Carolina, 미국, 27705
- Duke Asthma Allergy and Airway Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with a physician diagnosis of asthma for at least the previous 12 months.
- Asthma that is not well controlled by NAEPP guidelines.
- Ability and willingness to provide informed consent
Exclusion Criteria:
- Significant alcohol consumption of more than three alcoholic drinks per day or active substance abuse.
- Chronic disease (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency that are not well addressed or controlled.
- A diagnosis of cancer with ongoing treatment.
- Any terminal illness or conditions that results in a life expectancy less than one year.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Asthma Patients
Patient engagement toolkit
|
Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients.
These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of Asthma Exacerbations
기간: 12 weeks prior to baseline
|
The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline.
|
12 weeks prior to baseline
|
|
Rate of Asthma Exacerbations
기간: baseline to week 13
|
The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13
|
baseline to week 13
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Asthma Control
기간: baseline, 13 weeks
|
Measured by the Asthma Control Test (ACT), patient self-administered tool for identifying those with poorly controlled asthma.
The ACT assesses the frequency of dyspnea and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control.
5 items with 4-week recall.
The score range is 5-25 with >19 representing good control and <18 representing poor control.
|
baseline, 13 weeks
|
|
Change in Asthma Symptoms
기간: baseline, 13 weeks
|
Measured by asthma symptom utility index (ASUI). The Asthma Symptom utility Index (ASUI) is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of asthma-related symptoms and treatment side effects. Number of items 11 items with 2 week recall. Scores range from 0 (worst possible symptoms) to 1 (no symptoms) Minimal Clinically Important Difference (MCID) > 0.09 |
baseline, 13 weeks
|
|
Change in Pulmonary Function Tests
기간: baseline, 13 weeks
|
Measured by spirometry.
We measured forced expiratory volume in one second (FEV1) and forced vital capacity both in liters.
FEV1 is a measure of airflow obstruction.
The change in lung function is the change in these measurements compared to baseline.
|
baseline, 13 weeks
|
|
Number of Emergency Department and Hospitalization Visits
기간: Prior Year
|
Number of emergency department and hospitalizations visits will be recorded that occurred within the prior year.
|
Prior Year
|
|
Number of Emergency Department and Hospitalization Visits
기간: 13 weeks
|
Number of emergency department and hospitalization visits will be recorded
|
13 weeks
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Njira Lugogo, MD, Duke University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Patient engagement toolkit에 대한 임상 시험
-
Stanford UniversityTobacco Related Disease Research Program빼는
-
University of MichiganThe Craig H. Neilsen Foundation모집하지 않고 적극적으로
-
The University of QueenslandNational Health and Medical Research Council, Australia모병
-
Brigham and Women's HospitalGordon and Betty Moore Foundation완전한
-
AHS Cancer Control AlbertaTom Baker Cancer Centre모병
-
Brigham and Women's HospitalNational Institutes of Health (NIH); National Library of Medicine (NLM)알려지지 않은
-
Florida State UniversityUniversity of Michigan; University of Florida모병