Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Pilot Study)
Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
연구 개요
상세 설명
Despite proven benefits, the proportion of people with COPD who receive Pulmonary Rehabilitation (PR) is very small. The current model of a center-based PR program fails to address the needs of many patients with COPD. The most common patient barrier to attendance is travel to center-based programs, particularly for frail patients with more severe COPD who need transportation assistance. Home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective.
In this pilot study researchers will investigate barriers, facilitators and adherence to a home-based pulmonary rehabilitation program after hospitalization. The results of this pilot study will inform the second part of this study as a randomized control study under a different grant (Study 2/R33). Both quantitative and qualitative methods will be used for the evaluation.
10 patients will be enrolled in this pilot study and allocated to a home-based PR in order to polish the intervention before the randomized portion of the study. This pilot is supported by a grant mechanism (R61) explicitly oriented to adjust the intervention and identify barriers for the next randomized portion of this study (Study 2) supported by a separate grant mechanism (R33).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic in Rochester
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria
- COPD related hospitalization and eligible for PR
- Age 40+
- Confidence (score > 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)
Exclusion Criteria
- Inability to walk (orthopedic-neurologic problems or confined to bed)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention- Home Pulmonary Rehabilitation
Participants will be offered a Home-based pulmonary rehabilitation program with health coaching.
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환자가 집에서 PR(폐 재활)을 완료할 수 있도록 원격 시스템을 사용하여 건강 코칭을 제공하는 가정 기반 폐 재활(PR).
이 프로그램에는 상지 및 하지 운동, 증상 자가 보고(피로, 숨가쁨, 신체 활동 및 전반적인 웰빙)가 포함됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adherence to One Balance Practice Routine
기간: Baseline to 3 months
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Percentage of participants to adhere to one balance practice routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program
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Baseline to 3 months
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Adherence to Two Balance Practice Routine
기간: Baseline to 3 months
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Percentage of participants to adhere to two balance practices routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program
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Baseline to 3 months
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Adherence to Daily Flexible Practice Routine
기간: Baseline to 3 months
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Percentage of participants to adhere to the daily flexible practice routine for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program
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Baseline to 3 months
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Completion of the Daily Self-assessment
기간: Baseline to 3 months
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Percentage of participants to complete the daily self-assessment for 6 out of the 7 days for 12 weeks via the interactive home-based pulmonary rehabilitation program
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Baseline to 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary
기간: Baseline, 3 months
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The CRQ is a 20-question inventory assessing the areas of health related quality of life in dyspnea (shortness of breath), fatigue, emotion, and feelings of mastery of chronic respiratory disease.
The Physical Summary score includes dyspnea (symptom #1 in COPD) and fatigue (symptom #2 in COPD) domains.
The questions in each domain are added together and then divided by the number of questions.
The possible range is 1-7, where 1 is the worst and 7 the best.
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Baseline, 3 months
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Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary
기간: Baseline, 3 months
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The CRQ Emotion Summary score includes the emotion (independent factor for admissions and poor quality of life) and mastery (self-management) domains of the CRQ.
The scores for each domain are calculated by simply added together the answers and then dividing by the number of questions, the range is 1-7 where 1 is the worst and 7 the best.
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Baseline, 3 months
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Daily Physical Activity
기간: 3 months
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Average number of steps per day recorded by ActiGraph activity monitor worn on the wrist for seven days at 3 months
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3 months
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Change in the Self-Management Ability Scale (SMAS) Total Score
기간: Baseline, 3 months
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Measured using the total score from the self-reported SMAS 30 item questionnaire that measures ability and function.
A higher score indicates more ability and function in everyday life.
The SMAS30 has six areas, each with 5 questions.
The minimum score is one and the max is 5.
The mean is calculated for each section.
A higher score indicates better self management.
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Baseline, 3 months
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Change in Patient Health Questionnaire (PHQ-2)
기간: Baseline, 3 months
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Measured using the self-reported PHQ-2 consisting of a 2 item questionnaire inquiring about the frequency of depressed mood over the past 2 weeks on a scale of 0 to 3, 0=Not at all, 1=several days, 2=more than half the days, 3=nearly everyday.
The minimum score is zero and the highest score is 6.
A score greater than 3 may indicate depression.
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Baseline, 3 months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Roberto P Benzo, MD, Mayo Clinic
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 18-002453 (Pilot Study/R61)
- R61HL142933 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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