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노인 의료 입원 환자의 건강 결과를 개선하기 위한 보조 보행

2026년 11월 4일 업데이트: Michael Rothberg, The Cleveland Clinic

노인 의료 입원 환자의 건강 결과를 개선하기 위한 보조 보행의 무작위 시험

The investigator proposes to conduct a randomized trial of supervised ambulation delivered by mobility technician (MT) up to three times daily, including weekends, to hospitalized medical patients. The aims of the study are to compare the short and intermediate-term outcomes of patients randomized to the intervention versus those patients randomized to receive usual care, to identify patients who are most likely to benefit from the intervention and to assess whether the intervention increases or decreases overall costs of an episode of care, including the cost of the MTs, the index hospitalization and the first 30 days post enrollment.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

The investigator proposes to conduct a large randomized trial to test the impact of MTs (Mobility Technicians) on short and intermediate term outcomes for 3000 patients aged 65 years and older at 5 hospitals in 2 health systems. Patients will be randomized to receive supervised ambulation up to 3 times daily with a MT or to receive usual care. All participants will wear an accelerometer on their wrist to track their movement throughout the hospital stay. The study has 3 aims. First, the study will compare the mobility of patients at discharge (or 10 days) to assess the impact of the MTs on this outcome. Of particular interest is whether the use of MTs will increase the proportion of patients who can go home vs.post-acute care, and whether the improvements in mobility are sustained at 30 days. Second, the study will use predictive modeling to identify which patients are most likely to benefit from this intervention. Third, the study will assess the impact of the intervention on overall costs associated with the episode of care, including inpatient costs and the 30 days post enrollment. This information will be important to convince health systems to adopt this approach.

연구 유형

중재적

등록 (추정된)

3000

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Michael Rothberg, M.D.
  • 전화번호: 216-445-0719
  • 이메일: rothbem@ccf.org

연구 장소

    • Massachusetts
      • Springfield, Massachusetts, 미국, 01199
    • Ohio
      • Cleveland, Ohio, 미국, 44111
        • 모병
        • Fairview Hospital
        • 연락하다:
          • Michael Rothberg, MD
          • 전화번호: 216-445-0719
          • 이메일: rothbem@ccf.org
      • Cleveland, Ohio, 미국, 44195
        • 모병
        • Cleveland Clinic- Main Campus
        • 연락하다:
          • Michael Rothberg, MD
          • 전화번호: 216-445-0719
          • 이메일: rothbem@ccf.org
      • Garfield Heights, Ohio, 미국, 44125
        • 종료됨
        • Marymount Hospital
      • Mayfield Heights, Ohio, 미국, 44124
        • 모병
        • Hillcrest Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

65년 이상 (고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

Participants must meet all of the inclusion criteria listed below to participate in this study:

  1. ≥65 years of age
  2. Admitted to a medical service
  3. Complete history and physical examination on file
  4. 6-Clicks score of 16-23
  5. Insurance with Traditional Medicare or Medicare Advantage

Exclusion Criteria:

Any patient meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:

  1. Significant language barrier that requires a translator (other than Spanish at Baystate site only)
  2. Discharge planned for that day or the following day
  3. Observation status
  4. Surgical procedure planned
  5. Patients diagnosed with unstable angina or other medical conditions precluding participation in exercise/ambulation
  6. Permanent residence in a skilled nursing facility
  7. Comfort care measures only
  8. >48 hours since admission
  9. Active infection with COVID-19
  10. Other active infection requiring contact or droplet precautions
  11. Order for bedrest

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Usual Care

No intervention

실험적: Mobility Technician

Designated mobility technicians (MT) will ambulate hospitalized medical patients up to 3 times daily, 7 days per week, until discharge or a maximum of 10 days. Each day, the MT will visit the patient 4 times or until the patient successfully ambulates 3 times that day. In cases where a PT has provided a recommendation in the patient's chart, the MT will follow the recommendation, if feasible. Otherwise, the MT will execute the standard mobility protocol. The mobility protocol will allow the MT to assist a patient with an appropriate out-of-bed activity based on their 6-clicks score from the immediately preceding session

Designated mobility technicians (MT) will ambulate hospitalized medical patients up to 3 times daily, 7 days per week, until discharge or a maximum of 10 days. Each day, the MT will visit the patient 4 times or until the patient successfully ambulates 3 times that day. In cases where a PT has provided a recommendation in the patient's chart, the MT will follow the recommendation, if feasible. Otherwise, the MT will execute the standard mobility protocol. The mobility protocol will allow the MT to assist a patient with an appropriate out-of-bed activity based on their 6-clicks score from the immediately preceding session.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Short Physical Performance Battery (SPPB) from admission
기간: Up to 10 days

Every patient will have an SPPB score on admission to the study. A blinded assessor will measure the SPPB again at discharge or on day 10 if the patient is still hospitalized. The primary outcome is change from admission to discharge. Investigators will also compare the percentage of patients who reach the minimal clinically important difference of 1 point.

SPPB minimum value= 0 SPPB maximum value= 12 (higher score indicates a better outcome). If no blinded team member is available, the evaluation may be carried out by any unblinded team member. The blinding status of the evaluator will be noted in REDCap.

Up to 10 days

2차 결과 측정

결과 측정
측정값 설명
기간
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function - mobility
기간: 30 days post enrollment

Patients will complete the PROMIS physical function mobility bank via REDCap at 30 days post enrollment. PROMIS allows use of computer-adapted testing to measure patient-reported outcomes. The mobility question bank focuses on activities of physical mobility such as getting out of bed or a chair to walking up stairs. PROMIS measures were developed and validated with state-of-the-science methods supported by National Institutes of Health (NIH) funding. PROMIS was designed to enhance communication between clinicians and patients in diverse research and clinical settings and to be relevant across all conditions for the assessment of symptoms and functions.

PROMIS minimum value= 0 PROMISE maximum value= 100 (higher score indicates a better outcome)

30 days post enrollment
Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient short form (SF)
기간: 30 days post enrollment

Subjects will complete the AM-PAC at 30 days post enrollment and the score will be transformed using the t-scale. In addition to comparing AM-PAC scores at 30 days, the investigator will also compare change in t-score from admission. The AM-PAC 6-clicks (assessed in the hospital) and the AM-PAC outpatient SF are normed to the same t-scale, allowing for conversion from the one to the other. The 6-clicks is scored by a clinical proxy, while the SF AM-PAC is self-reported, allowing for initial assessment by the MT and 30-day self-report by the patient. Previous studies have demonstrated adequate validity of mobility assessment via the AM-PAC using clinical or family proxies. To improve interpretability, investigators will compare the percentage of patients who reach the minimal clinically important difference of 3 points on the t-scale.

AM-PAC minimum value= 29.41 AM-PAC maximum value= 80.30 (higher score indicates a better outcome)

30 days post enrollment
Hospital-Acquired Complications
기간: 10 days

Composite outcome of venous thromboembolism, fall with injury, pressure ulcers or hospital-acquired pneumonia. Hospital-acquired complications will be identified from the electronic health record and from the falls reporting system. All falls will be examined, whether occurring during assisted ambulation or otherwise. Only falls with injury will be included in the hospital-acquired complications measure. Outcomes will be adjudicated by blinded reviewers. While investigators are primarily interested in the composite measure, investigators will also examine the individual components separately.

10 days
Number of Patients with Readmission within 30 days
기간: 30 days after discharge

All cause readmission within 30 days of discharge from the index hospitalization.

30 days after discharge
Activities of Daily Living
기간: 30 days post enrollment

Activities of daily living as measured by the Katz and Lawton scales.

Katz minimum value= 0 Katz maximum value= 6 (higher score indicates a better outcome) Lawton minimum value= 0 Lawton maximum value= 8 (higher score indicates a better outcome)

30 days post enrollment
Frailty
기간: 30 days post enrollment

Frailty as measured by the Fatigue, Resistance, Ambulation,Illness, and Loss of weight (FRAIL) scale.

FRAIL minimum value= 0 FRAIL maximum value= 5 (higher score indicates a worse outcome)

30 days post enrollment
Total episode cost
기간: Admission to 30 days post enrollment

Investigators will estimate total cost of the episode of care including the index admission (from hospital cost accounting systems), the personnel costs for the MTs (using hourly wages plus benefits), and all non-medication costs for the 30 days post-enrollment (from Medicare claims).

Admission to 30 days post enrollment
Number of Patients Discharged to Home
기간: date of randomization to date of discharge, up to 30 days

Based on the discharge disposition in the medical record, investigators will identify whether the patient was discharged to home.

date of randomization to date of discharge, up to 30 days
Length of Stay
기간: date of admission to date of discharge, up to 30 days

Length of stay will be calculated as whole days from the time of admission to the time of discharge.

date of admission to date of discharge, up to 30 days
Mortality
기간: 30 days from admission

Patient's vital status will be ascertained from the EHR, Medicare claims or from follow-up phone calls.

30 days from admission
Total episode cost
기간: Admission to 6 months after enrollment

Investigators will estimate total cost of the episode of care including the index admission (from hospital cost accounting systems), the personnel costs for the MTs (using hourly wages plus benefits), and all non-medication costs for the 6 months post-enrollment (from Medicare claims).

Admission to 6 months after enrollment
Falls post-discharge
기간: 30 days from admission

Whether the patient has fallen, whether it was multiple times and whether an injury occurred will be assessed via telephone

30 days from admission
RCSQ (Richards Campbell Sleep Questionnaire)
기간: Days 1-10

Five question sleep survey which measures overall quality of sleep. Patients in both study arms will complete the questionnaire each morning regarding the previous night's sleep.

Days 1-10

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Michael Rothberg, M.D., The Cleveland Clinic

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 5월 15일

기본 완료 (추정된)

2026년 11월 30일

연구 완료 (추정된)

2026년 12월 30일

연구 등록 날짜

최초 제출

2023년 1월 11일

QC 기준을 충족하는 최초 제출

2023년 2월 10일

처음 게시됨 (실제)

2023년 2월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 4일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 22-426
  • 1R01AG073278-01A1 (미국 NIH 보조금/계약)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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