- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07691411
An Ecological Momentary Assessment Based Program to Support Self-Management for Post-stroke Patients
Combining Machine Learning and Ecological Momentary Assessment of Depression, Cognitive Function and Daily Activity Behavior to Support Self-Management for Post-stroke Patients: A Feasibility Study
The goal of this feasibility study is to test whether a new approach that combines real-time symptom tracking (Ecological Momentary Assessment) with machine learning can help people recovering from a stroke to better manage depression, thinking difficulties, and daily functioning. The main questions it aims to answer are:
Is this combined approach practical and acceptable for post-stroke survivors? Does the program improve mood, cognitive function, or functional ability to carry out daily activities?
Participants will:
Use a smartphone app called RehabCare Companion for a period of time Answer brief daily surveys about their mood, thoughts, and activities for one week Receive personalized self-care suggestions generated by machine learning based on their responses Complete assessments of depression, cognition, and functioning before and after the program Take part in a group interview to share their experiences
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Arkers KC Prof. Wong, PhD
- Telefonnummer: +852 34003805
- E-Mail: arkers.wong@polyu.edu.hk
Studieren Sie die Kontaktsicherung
- Name: Nuo Dr. Shi, DHSc
- Telefonnummer: +852 34008172
- E-Mail: nuo-catherine.shi@polyu.edu.hk
Studienorte
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Hong Kong
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Hong Kong, Hong Kong, Hongkong, 999077
- Rekrutierung
- Queen Elizabeth Hospital
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Kontakt:
- Vivian WY Ms. Kwok
- Telefonnummer: +852 34003805
- E-Mail: arkers.wong@polyu.edu.hk
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- adults aged 18 years or older
- having a confirmed diagnosis of stroke
- having sufficient proficiency in Cantonese to understand and respond to the assessments and prompts
- having a Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA) score of 18 or higher
- having a smartphone.
Exclusion Criteria:
- they have moderate to severe cognitive impairment (a HK-MoCA score of 17 or lower)
- they have active psychiatric disorders other than depression (e.g., schizophrenia, bipolar disorder)
- they have a terminal illness or prognosis that suggests a limited life expectancy
- they have conditions that compromise their self-care ability (i.e., bedbound).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Ecological Momentary Assessment based Self-management Program
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The research team collects participants' EMA data (ie., depression, cognitive function, daily activity, and contextual data) from participants for 7-day and analyze the data by machine learning in the first phase, while provide real-time, individualized, self-care messages to the participants via a personalized self-care AI app in the second phase.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Feasibility of the study: acceptance
Zeitfenster: Immediately after the intervention (T2).
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The acceptance of participants to the program will be measured by recruitment rate, attrition rate, and retention rate.
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Immediately after the intervention (T2).
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Feasibility of the study: adherence
Zeitfenster: Immediately after the intervention (T2).
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The adherence of the participants will be evaluated by using the percentage of completed EMA assessments and the frequency of app usage.
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Immediately after the intervention (T2).
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Feasibility of the study: experience of the participants in using the app
Zeitfenster: Immediately after the intervention (T2).
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Participants' experience will be assessed through individual interviews.
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Immediately after the intervention (T2).
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Preliminary effectiveness: depression Levels
Zeitfenster: Pre-intervention (T1) and immediately after the intervention (T2).
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Beck Depression Inventory (BDI) will be used to assess the depression levels of post-stroke patients.
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Pre-intervention (T1) and immediately after the intervention (T2).
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Preliminary effectiveness: cognitive function
Zeitfenster: Pre-intervention (T1) and immediately after the intervention (T2).
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Cognitive function will be screened using Montreal Cognitive Assessment Hong Kong version (HK-MoCA).
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Pre-intervention (T1) and immediately after the intervention (T2).
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Preliminary effectiveness: disability and functioning
Zeitfenster: Pre-intervention (T1) and immediately after the intervention (T2).
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The World Health Organization Disability Assessment Schedule (WHODAS 2.0) is a widely used instrument for assessing disability and functioning in individuals.
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Pre-intervention (T1) and immediately after the intervention (T2).
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Arkers KC Wong, PhD, The Hong Kong Polytechnic University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
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
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- WZ8L
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