- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04379349
Using Short Message Service as a Means of Clinical Engagement in Early Psychosis
6. maj 2020 opdateret af: George Foussias, Centre for Addiction and Mental Health
Engagement with clinical services for youth with early psychosis represents a significant challenge, with up to 40% of patients dropping out of treatment in the first year.
This has been linked to worse illness outcomes and represents a significant barrier to recovery for these patients.
This study aims to evaluate the efficacy of short message service (SMS) as a means of improving clinical engagement in early-episode psychosis populations by bridging contact between appointments with weekly check-ins/reminders.
These weekly check-ins during the first year of treatment will serve as an additional opportunity to reach out to patients and give them a chance to do the same with their care teams, with patient responses triggering clinician follow-up if necessary.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
61
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 1R8
- Centre for Addiction and Mental Health
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år til 29 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- between the ages of 16-29
- a diagnosis of an affective or non-affective psychotic disorder (i.e., Bipolar or Major Depressive Disorders with Psychotic Features, Schizophrenia Spectrum Disorders, Other Specified Psychotic Disorders, Substance Induced Psychosis and Attenuated Psychotic Syndrome)
- eligible for follow-up within the Slaight Family Centre for Youth in Transition early intervention service
- within the first 6 months of treatment
Exclusion Criteria:
- involved in another intervention study
- do not have a personal cell phone number
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Active SMS
Weekly interactive SMS text messaging check-ins.
|
Interactive SMS text message check-ins delivered once weekly to participants.
|
|
Sham-komparator: Sham SMS
Weekly minimally interactive SMS text messages.
|
Minimally interactive SMS text message delivered once weekly to participants.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Service Engagement Scale (SES)
Tidsramme: 9 months
|
Clinician-rated treatment engagement and adherence (minimum score = 0, maximum score = 42, higher score indicates worse service engagement)
|
9 months
|
|
Appointment Attendance
Tidsramme: 9 months
|
Percentage of attended clinic appointments
|
9 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Emergency Department Visits
Tidsramme: 9 months
|
Number of emergency department visits
|
9 months
|
|
Hospitalizations
Tidsramme: 9 months
|
Number of hospitalizations
|
9 months
|
|
Social Functioning Scale (SFS)
Tidsramme: 9 months
|
Self-report measure of social functioning (minimum score = 0, maximum score = 247, higher score indicates better functioning)
|
9 months
|
|
Personal and Social Performance Scale (PSP)
Tidsramme: 9 months
|
Interview-rated measure of global functioning (minimum score = 1, maximum score = 100, higher score indicates better functioning)
|
9 months
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LESQ-18)
Tidsramme: 9 months
|
Self-reported measure of subjective quality of life (minimum score = 1, maximum score = 5, higher score indicates better quality of life)
|
9 months
|
|
Clinical Global Impression (CGI)
Tidsramme: 9 months
|
Interview-based global rating of illness severity (minimum score = 1, maximum score = 7, higher score indicates worse illness severity)
|
9 months
|
|
Brief Psychiatric Rating Scale (BPRS)
Tidsramme: 9 months
|
Interview-based measure of the severity of psychiatric symptoms (minimum score = 24, maximum score = 168, higher score indicates higher severity of symptoms)
|
9 months
|
|
Scale for the Assessment of Negative Symptoms (SANS)
Tidsramme: 9 months
|
Interview-based measure of the severity of negative symptoms (minimum score = 0, maximum score = 110, higher score indicates higher severity of symptoms)
|
9 months
|
|
Apathy Evaluation Scale (AES)
Tidsramme: 9 months
|
Interview-rated measure of the severity of motivation deficits (minimum score = 18, maximum score = 72, higher score indicates worse motivation deficits)
|
9 months
|
|
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
Tidsramme: 9 months
|
Rater-administered measure of cognitive functioning (scores indicate standardized Z-scores with no pre-defined minimum or maximum score, higher score indicates better cognitive functioning)
|
9 months
|
|
Drug Attitude Inventory (DAI-10)
Tidsramme: 9 months
|
Self-reported measure of medication adherence (minimum score = -10, maximum score = + 10, higher score indicates better adherence)
|
9 months
|
|
Scale To Assess Therapeutic Relationships - Patient Version (STAR-P)
Tidsramme: 9 months
|
Self-reported measure of the clinician-patient therapeutic relationship (minimum score = 0, maximum score = 48, higher score indicates better therapeutic relationship)
|
9 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: George Foussias, MD PhD, Centre for Addiction and Mental Health
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2018
Primær færdiggørelse (Faktiske)
31. marts 2020
Studieafslutning (Faktiske)
31. marts 2020
Datoer for studieregistrering
Først indsendt
5. maj 2020
Først indsendt, der opfyldte QC-kriterier
5. maj 2020
Først opslået (Faktiske)
7. maj 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. maj 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. maj 2020
Sidst verificeret
1. maj 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 091-2017
Plan for individuelle deltagerdata (IPD)
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