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Recruiting NCT07691411

An Ecological Momentary Assessment Based Program to Support Self-Management for Post-stroke Patients

No phase Interventional Stroke Post Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ecological Momentary Assessment based Self-management Program.
Who it may be relevant to
Registry conditions: Stroke, Post Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Behavioral Ecological Momentary Assessment based Self-management Program
    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.

Primary outcome measures

  • Feasibility of the study: acceptance [Time frame: Immediately after the intervention (T2).]
  • Feasibility of the study: adherence [Time frame: Immediately after the intervention (T2).]
  • Feasibility of the study: experience of the participants in using the app [Time frame: Immediately after the intervention (T2).]
Secondary outcome measures (3)
  • Preliminary effectiveness: depression Levels [Time frame: Pre-intervention (T1) and immediately after the intervention (T2).]
  • Preliminary effectiveness: cognitive function [Time frame: Pre-intervention (T1) and immediately after the intervention (T2).]
  • Preliminary effectiveness: disability and functioning [Time frame: Pre-intervention (T1) and immediately after the intervention (T2).]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Hong Kong · 1 center
  • Queen Elizabeth Hospital — Hong Kong

Identifiers

NCT: NCT07691411 · WZ8L

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗