COVID-19 and Social Isolation and Loneliness Trial (SIL)
A Phase IIb 3 Arm Randomized Clinical Pilot Study to Assess the Impact of a Peer-support Program to Improve Social Isolation and Loneliness Due to COVID-19 - Comparing the Addition of a Secure, User Friendly Video-conference Solution and Telephone Support Alone to a Waiting List Control Group
Social isolation and loneliness worsen older peoples' quality of life, risk of dementia, and contributes to 45,000 deaths/year in Canada - as much as smoking. Isolated people use the health care system more often, but have worse outcomes. Effective, inexpensive interventions exist but unfortunately they have not been implemented in Canada.
We partnered with the Australian developer of HOW R U?, an effective and feasible intervention that uses specially trained, older, hospital volunteers to provide peer support to combat isolation and loneliness in isolated older peers.
Little is known about older people's preferences for virtual care (telephone vs. video) nor their relative effectiveness. Thus we will compare two ways of delivering HOW R U: telephone support and a tested, secure user-friendly video conferencing app, aTouch Away® to a common control arm.
We also partnered with Emergency Medicine, Family Medicine, Geriatrics and Psychiatry to identify people who will benefit from peer support; and with Volunteer Services to recruit volunteers.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jacques Lee, MD
- 전화번호: 4168771447
- 이메일: Jacques.lee@sinaihealth.ca
연구 연락처 백업
- 이름: Joanna Yeung, HBSc
- 전화번호: 6473089440
- 이메일: Joanna.yeung@sinaihealth.ca
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5G 1XS
- 모병
- Mount Sinai Hospital
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연락하다:
- Jacques Lee, MD
- 이메일: Jacques.lee@sinaihealth.ca
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Any community-dwelling person 70 years of age and older receiving care from the ED, Family Medicine, or Geriatric clinics at our two participating sites (MSH and NYGH) will be eligible.
Exclusion Criteria:
- age less than 70 years; communication problems (critically ill, unconscious, language barrier, speech impairment or otherwise unable to provide consent), or admission to a hospital for > 72 hours. Patients with severe cognitive impairment or those living in nursing homes who are dependent on others for their activity of daily living will be excluded. To target the intervention for older people with loneliness a baseline de Jonge loneliness scores of 2.0 will be required for participation in the trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: HOW RU Intervention delivered by telephone
Group Phone will receive the HOW RU? intervention over the telephone.
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HOW RU? intervention uses trained volunteer peers to provide strength-based support sessions weekly for 12 weeks.
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실험적: HOW RU Intervention delivered by video-call
Group Video will receive the HOW RU? intervention delivered over video-call using the aTouch Away platform.
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HOW RU? intervention uses trained volunteer peers to provide strength-based support sessions weekly for 12 weeks.
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간섭 없음: Wait-list Control Group
Control groups will be offered standard care through their referring service (i.e.
their routine clinical follow-up).
The control group will be offered HOW RU? telephone support outside of the main trial after their primary outcome assessment at 12 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in De Jong Gierveld Loneliness Scale at Baseline
기간: This scale will be collected at baseline and at 12 weeks.
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We will use the 6-item De Jong Gierveld loneliness scale as our primary outcome measure.The minimum value is 0 and the maximum value is 6.
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This scale will be collected at baseline and at 12 weeks.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Social Network
기간: Baseline and at 12 weeks
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Lubben's Social Network Scale
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Baseline and at 12 weeks
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Change in Mood
기간: Baseline and at 12 weeks
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Geriatric Depression Scale
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Baseline and at 12 weeks
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Change in Quality of life
기간: Baseline and at 12 weeks
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EQ-5D-5L survey
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Baseline and at 12 weeks
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all-cause mortality
기간: Follow-up phone call at 12 weeks
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Follow-up phone call at 12 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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 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. .