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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jacques Lee, MD
- 電話番号：4168771447
- メール：Jacques.lee@sinaihealth.ca
研究連絡先のバックアップ
- 名前：Joanna Yeung, HBSc
- 電話番号：6473089440
- メール：Joanna.yeung@sinaihealth.ca
研究場所
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-
Ontario
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Toronto、Ontario、カナダ、M5G 1XS
- 募集
- Mount Sinai Hospital
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コンタクト：
- Jacques Lee, MD
- メール：Jacques.lee@sinaihealth.ca
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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介入なし：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in De Jong Gierveld Loneliness Scale at Baseline
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Social Network
時間枠：Baseline and at 12 weeks
|
Lubben's Social Network Scale
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Baseline and at 12 weeks
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Change in Mood
時間枠：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
時間枠：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
時間枠：Follow-up phone call at 12 weeks
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Follow-up phone call at 12 weeks
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。