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WalkMORE: Volunteer Walking Coach Program for Hospitalized Internal Medicine Patients

2019년 3월 13일 업데이트: Lawson Health Research Institute

WalkMORE: Volunteer Walking Coach Program for Hospitalized Internal Medicine Patients, a Pilot Randomized Controlled Trial

Patients admitted to hospital typically experience periods of decreased activity or bed-rest. This reduced activity level leads to deconditioning - a loss of muscle mass, muscle strength (by 2-5% per day), and muscle shortening. Even among patients who were ambulatory at the time of admission, deconditioning has been linked with deleterious effects, such as increased rates of falls, functional decline, and frailty. Furthermore, it has been suggested that the physiological stresses associated with hospitalization - including deconditioning, as well as sleep deprivation and poor nutrition - makes discharged patients vulnerable to recurrent or new illnesses and to frailty. This physiological stress-induced vulnerability has been coined post-hospital syndrome and is thought to have a role in most hospital readmissions.

The investigators hypothesize that by engaging ambulatory patients to walk with trained volunteer coaches, patients will increase their amount of walking, have less deconditioning and functional decline, and consequently, fewer falls. Furthermore, the investigators anticipate that patients who walk with a trained coach will have reduced length-of-stay in hospital and decreased likelihood of readmission. Finally, as shown in other programs trialing health coaches, the investigators anticipate an overall improvement in the patient experience.

Our aim is to demonstrate the feasibility of an intentional walking protocol called WalkMORE, which pairs trained volunteer coaches with ambulatory patients admitted to the Internal Medicine unit (4th floor University Hospital), aimed at decreasing deconditioning through increased walking.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

WalkMORE is a single-center randomized controlled trial. The investigators will enroll up to 300 ambulatory patients admitted to the Internal Medicine unit (located on the 4th floor of University Hospital) who are >18 years of age and are anticipated to require a >48 hour hospital admission. A maximum of 6 patients will be assigned to each treatment arm at any given time. The investigators will recruit patients into the WalkMORE program over a 3-month period. The research coordinator (RC) will screen patients admitted to the Internal Medicine unit in the preceding 24-hour period to identify patients who fulfill the eligibility criteria. Patients will be randomized via REDCap (Research Electronic Data Capture), a secure, centralized web-based randomization module to:

  1. Standard of care; or
  2. WalkMORE Ambulation program + Standard of care. Patients will ambulate with a trained WalkMORE Volunteer Coach two times per day; once in the morning (0900-1200hrs) and once in the afternoon (1300-1700hrs), Monday- Friday, until hospital discharge. Patients randomized to the WalkMORE intervention will be assessed daily by the RC to ensure patients remain fit for independent ambulation. The duration of each walking session will be determined daily by the RC and the medical team.

After obtaining written informed consent from eligible patients the RC will randomize patients, collect demographics, hospital admission details and perform a quality of life survey (EQ-5D) with all patients. All patients will be assigned a scientific pedometer on the day of randomization. The modus Health StepWatch™ is an activity monitor worn on the ankle via a velcro strap. It is a small, lightweight device that will count and record patients' steps throughout their hospital stay. The device is smaller than a deck of cards (7.5 x 5.0 x 2.0 cm) and weighs 38 grams and will be installed by the RC. The total number of steps recorded on the pedometer will be collected for each patient every day until hospital discharge. For patients randomized to the WalkMORE intervention arm, the total number of minutes walked with a volunteer coach will also be recorded for each session until discharge. Functional ability will be measured on the third day post-randomization and every three days thereafter until hospital discharge, using the Timed Up and Go test (patients will be asked to stand up from a chair, walk three metres, turn around, walk back to the chair, and sit). After hospital discharge the RC will follow up with patients for 2 brief telephone interviews. On day 3 after discharge, Patient Satisfaction surveys will be conducted by the RC to assess patient satisfaction with their experience with the WalkMORE program. These telephone surveys will be reviewed and approved by Lisa Hawthorne of the Patient Experience Office. On day 30 after discharge the RC will contact patients to conduct a brief quality of life survey and to collect data regarding clinical outcomes (ER visits, re-hospitalizations, and falls). Each telephone interview is expected to last approximately 10-15 minutes.

연구 유형

중재적

등록 (실제)

150

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

    • Ontario
      • London, Ontario, 캐나다, N6A 5A5
        • LHSC-University Hospital

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Capable and appropriate for independent ambulation (with or without gait aids) as determined by the health care team at time of admission
  2. Cognitively safe for participation
  3. Anticipated to remain hospitalized ≥48 hours
  4. Age >18 years

Exclusion Criteria:

  1. Preexisting condition precludes patient from independent ambulation at time of admission.
  2. Active medical condition precludes patient from safely participating.
  3. Preexisting condition or active medical condition renders patient unfit to participate as judged by the admitting team.
  4. Patients who refuse to participate or are unable to provide informed consent.
  5. Patients that are non-English speaking.

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: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 제어
환자는 개입을 받지 않습니다.
실험적: WalkMORE group
WalkMORE Ambulation program. Patients will ambulate with a trained WalkMORE Volunteer Coach two times per day; once in the morning (0900-1200hrs) and once in the afternoon (1300-1700hrs), Monday- Friday, until hospital discharge.
Hospitalized Internal Medicine patients will walk with trained volunteer coaches twice daily until hospital discharge

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Patient Recruitment
기간: 3 months
Ability to recruit sufficient number of patients
3 months

2차 결과 측정

결과 측정
측정값 설명
기간
Patient Safety
기간: 6 months
Number of participants that experience a fall during the study intervention as reported by WalkMORE volunteer coaches.
6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

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)

2018년 6월 6일

기본 완료 (실제)

2018년 12월 10일

연구 완료 (실제)

2019년 1월 9일

연구 등록 날짜

최초 제출

2017년 11월 27일

QC 기준을 충족하는 최초 제출

2017년 12월 1일

처음 게시됨 (실제)

2017년 12월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 3월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 3월 13일

마지막으로 확인됨

2019년 3월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • ReDA 4304

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

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미국 FDA 규제 의약품 연구

아니

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아니

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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