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- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Arkers KC Prof. Wong, PhD
- Numéro de téléphone: +852 34003805
- E-mail: arkers.wong@polyu.edu.hk
Sauvegarde des contacts de l'étude
- Nom: Nuo Dr. Shi, DHSc
- Numéro de téléphone: +852 34008172
- E-mail: nuo-catherine.shi@polyu.edu.hk
Lieux d'étude
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Hong Kong
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Hong Kong, Hong Kong, Hong Kong, 999077
- Recrutement
- Queen Elizabeth Hospital
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Contact:
- Vivian WY Ms. Kwok
- Numéro de téléphone: +852 34003805
- E-mail: arkers.wong@polyu.edu.hk
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Feasibility of the study: acceptance
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Preliminary effectiveness: depression Levels
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Arkers KC Wong, PhD, The Hong Kong Polytechnic University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- WZ8L
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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