- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07590076
Volunteer Facilitated Discharge Assistance and Supports at Home (DASH) for People With Stroke (DASH)
Volunteer Facilitated Discharge Assistance and Supports at Home (DASH) for People With Stroke: An Effectiveness-implementation Hybrid Trial.
The goal of this clinical trial is to learn if a home visit by a trained volunteer can improve stroke recovery after a stroke survivor is discharged home from the hospital. The main questions it aims to answer are:
- After 3 months of being discharged from the hospital, does this additional volunteer support at home improve coping skills for stroke survivors?
- Does the effects of the volunteer support last over 3 to 6 months after being discharged home?
Researchers will compare between a group who will receive the volunteer support and a group who will not to see if the additional support can improve stroke recovery.
Participants will:
- Either receive volunteer support over an 8-week time period OR receive no additional volunteer support
- Continue with their usual care plan and receive educational resources from the research team during the study
- Complete online surveys during study enrollment, at 3 months, and at 6 months after hospital discharge
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Michelle LA Nelson, MA, PhD, FAHA, FWSO
- Numero di telefono: 647-938-4425
- Email: mla.nelson@uottawa.ca
Backup dei contatti dello studio
- Nome: Research Coordinator
- Email: TMoni@bruyere.org
Luoghi di studio
-
-
Ontario
-
Ottawa, Ontario, Canada
- Bruyère Health Élisabeth-Bruyère Hospital
-
Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre
-
Toronto, Ontario, Canada
- Hennick Bridgepoint Hospital
-
Toronto, Ontario, Canada
- Providence Healthcare (Unity Health Toronto)
-
Toronto, Ontario, Canada
- Toronto Rehabilitation Institute (UHN)
-
Toronto, Ontario, Canada
- West Park Healthcare Centre (UHN)
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Confirmed diagnosis of stroke
- Either undergoing or recently completed in-patient rehabilitation within the last 3 weeks
- Lived at home pre-stroke
- Discharged directly home (to own residence or that of a family member)
- Live in one of the program implementation areas (i.e., Toronto, Ottawa)
Exclusion Criteria:
- Discharged to additional hospital inpatient care, nursing home, or other long-term care
- Inability to communicate in English
- Inability to provide informed consent due to cognitive deficits
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Group A: DASH group
Participants will receive the DASH intervention + Usual Care + Educational Resources
|
One-on-one weekly visits in the stroke survivor participants' residence by a trained volunteer for approximately 8 weeks (about 2 months). Volunteer support could span three types: i) instrumental activities of daily living assistance (e.g., assistance with meal preparation, light house duties, and transportation), ii) psychosocial support (e.g., befriending visits), and iii) informational supports (signposting to other community services). |
|
Nessun intervento: Group B: Usual care group
Participants will receive the Usual Care + Educational Resources
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Coping at Time 1 as assessed by Post-Discharge Coping Difficulty Scale (PDCDS)
Lasso di tempo: Measured at 3 months post-hospital discharge
|
Coping will be assessed using the Post-Discharge Coping Difficulty Scale (PDCDS), a 10-item patient-reported outcome measure evaluating perceived difficulty coping following hospital discharge.
Each item is scored on a scale from 0 to 10. Item scores are summed to yield a total score ranging from 0 to 100, with higher scores indicating greater difficulty coping.
|
Measured at 3 months post-hospital discharge
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in coping as assessed by Post-Discharge Coping Difficulty Scale (PDCDS)
Lasso di tempo: Measured at 3 months and 6 months post-hospital discharge
|
Coping will be assessed using the Post-Discharge Coping Difficulty Scale (PDCDS), a 10-item patient-reported measure.
Each item is scored from 0 to 10, with total scores ranging from 0 to 100.
Change in total score will be calculated between time points.
Higher scores indicate greater difficulty coping.
|
Measured at 3 months and 6 months post-hospital discharge
|
|
Change in quality of life as assessed by Stroke-Specific Quality of Life (SS-QOL)
Lasso di tempo: Measured at 3 months and 6 months post-hospital discharge
|
Quality of life will be assessed using the Stroke-Specific Quality of Life (SS-QOL) scale, a 49-item patient-reported measure evaluating multiple domains of health-related quality of life in stroke survivors.
Each item is scored on a 5-point Likert scale (1 to 5).
Domain scores are calculated as the average of items within each domain, and the overall score is calculated as the average of all domain scores or as the sum of all 49 items (ranging 49 to 245).
Higher scores indicate better quality of life.
|
Measured at 3 months and 6 months post-hospital discharge
|
|
Change in symptoms of depression as assessed by Patient Health Questionnaire-9 (PHQ-9)
Lasso di tempo: Measured at 3 months and 6 months post-hospital discharge
|
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item patient-reported measure.
Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
|
Measured at 3 months and 6 months post-hospital discharge
|
|
Change in social isolation and loneliness indicators as assessed by UCLA Loneliness Scale (Version 3)
Lasso di tempo: Measured at 3 months and 6 months post-hospital discharge
|
Social isolation and loneliness will be assessed using the UCLA Loneliness Scale (Version 3), a 20-item patient-reported measure evaluating subjective feelings of loneliness and social isolation.
Each item is scored on a 4-point scale.
Total scores range from 20 to 80, with higher scores indicating greater loneliness.
|
Measured at 3 months and 6 months post-hospital discharge
|
Collaboratori e investigatori
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Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 191308
- 5161 (Altro identificatore: Clinical Trials Ontario)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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