- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02622282
Text Messaging to Promote Walking Among Latino Adults at Risk for Peripheral Arterial Disease
Text Messaging to Promote Walking Among Latino Adults at Risk for PAD
연구 개요
상세 설명
Thirty-five million Latinos live in the U.S. and nearly 14% have peripheral arterial disease (PAD) defined as a build-up of plaque in the arteries that supply blood to the legs. Approximately 40% have at least one risk for PAD (i.e., aged 70 years and older, diabetes, high blood pressure, high blood cholesterol, or smoking). Persons with at least one risk factor and who are physically inactive are more likely to suffer from severe PAD. Physical inactivity is highly prevalent in Latinos and a major risk factor for PAD. Physical inactivity affects 50% of Latinos aged 60 years and older.
Participation in this study will last for about 3 months. Participants will be randomized to one of two groups. One group will receive text messages, brief telephone calls, and a handout. The other group will only receive the handout. The study will be looking at how the different groups respond to the different interventions used in the study.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kansas
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Wichita, Kansas, 미국, 67214
- KU School of Medicine - Wichita
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Latino adults
- English or Spanish speaking
- Have one or more of the following: diabetes mellitus, smoking, hypertension, or hyperlipidemia.
- Adults age 70 years or older, regardless of having one or more the above noted risk factors for PAD, will also be eligible for enrollment.
Exclusion Criteria:
- Pregnancy
- Prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers)
- Use of supplemental oxygen
- Myocardial infarction within preceding 3 months
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Experimental Group
Participants will receive text messages and telephone calls during the length of their participation.
Participants will receive a handout with information on PAD and physical activity.
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Text messages will be sent one time per day.
Text messages will include messages to motivate and inform participants on the importance of walking.
Participants may receive a telephone call every two weeks for one month followed by once per month for two months.
Handout includes information specific to participant's condition and ways to promote an active lifestyle.
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활성 비교기: Control Group
Participants will receive a handout with information on PAD and physical activity.
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Handout includes information specific to participant's condition and ways to promote an active lifestyle.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Physical Activity
기간: Change from Baseline to 3 Months
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All participants will use a pedometer.
Mean change will be measured based on steps per day.
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Change from Baseline to 3 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Exercise Behavior
기간: Change from Baseline to 3 Months
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Change will be measured using the Exercise Behaviors Survey.
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Change from Baseline to 3 Months
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Change in Quality of Life
기간: Change from Baseline to 3 Months
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Change will be measured using the Medical Outcomes Study (MOS) Short Form 36.
The survey has 36 questions.
Scores are coded based on response by participant.
A score of 100 indicates the most favorable situation while a score of 0 would indicate the least favorable.
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Change from Baseline to 3 Months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Tracie C. Collins, MD, MPH, University of Kansas Medical Center
간행물 및 유용한 링크
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 (추정)
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. .
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