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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Jacques Lee, MD
- Telefonnummer: 4168771447
- E-Mail: Jacques.lee@sinaihealth.ca
Studieren Sie die Kontaktsicherung
- Name: Joanna Yeung, HBSc
- Telefonnummer: 6473089440
- E-Mail: Joanna.yeung@sinaihealth.ca
Studienorte
-
-
Ontario
-
Toronto, Ontario, Kanada, M5G 1XS
- Rekrutierung
- Mount Sinai Hospital
-
Kontakt:
- Jacques Lee, MD
- E-Mail: Jacques.lee@sinaihealth.ca
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: HOW RU Intervention delivered by telephone
Group Phone will receive the HOW RU? intervention over the telephone.
|
HOW RU? intervention uses trained volunteer peers to provide strength-based support sessions weekly for 12 weeks.
|
|
Experimental: HOW RU Intervention delivered by video-call
Group Video will receive the HOW RU? intervention delivered over video-call using the aTouch Away platform.
|
HOW RU? intervention uses trained volunteer peers to provide strength-based support sessions weekly for 12 weeks.
|
|
Kein Eingriff: 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in De Jong Gierveld Loneliness Scale at Baseline
Zeitfenster: This scale will be collected at baseline and at 12 weeks.
|
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.
|
This scale will be collected at baseline and at 12 weeks.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Social Network
Zeitfenster: Baseline and at 12 weeks
|
Lubben's Social Network Scale
|
Baseline and at 12 weeks
|
|
Change in Mood
Zeitfenster: Baseline and at 12 weeks
|
Geriatric Depression Scale
|
Baseline and at 12 weeks
|
|
Change in Quality of life
Zeitfenster: Baseline and at 12 weeks
|
EQ-5D-5L survey
|
Baseline and at 12 weeks
|
|
all-cause mortality
Zeitfenster: Follow-up phone call at 12 weeks
|
Follow-up phone call at 12 weeks
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 21-0074E
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .