- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arkers KC Prof. Wong, PhD
- Phone Number: +852 34003805
- Email: arkers.wong@polyu.edu.hk
Study Contact Backup
- Name: Nuo Dr. Shi, DHSc
- Phone Number: +852 34008172
- Email: nuo-catherine.shi@polyu.edu.hk
Study Locations
-
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Hong Kong
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Hong Kong, Hong Kong, Hong Kong, 999077
- Recruiting
- Queen Elizabeth Hospital
-
Contact:
- Vivian WY Ms. Kwok
- Phone Number: +852 34003805
- Email: arkers.wong@polyu.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the study: acceptance
Time Frame: Immediately after the intervention (T2).
|
The acceptance of participants to the program will be measured by recruitment rate, attrition rate, and retention rate.
|
Immediately after the intervention (T2).
|
|
Feasibility of the study: adherence
Time Frame: Immediately after the intervention (T2).
|
The adherence of the participants will be evaluated by using the percentage of completed EMA assessments and the frequency of app usage.
|
Immediately after the intervention (T2).
|
|
Feasibility of the study: experience of the participants in using the app
Time Frame: Immediately after the intervention (T2).
|
Participants' experience will be assessed through individual interviews.
|
Immediately after the intervention (T2).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preliminary effectiveness: depression Levels
Time Frame: Pre-intervention (T1) and immediately after the intervention (T2).
|
Beck Depression Inventory (BDI) will be used to assess the depression levels of post-stroke patients.
|
Pre-intervention (T1) and immediately after the intervention (T2).
|
|
Preliminary effectiveness: cognitive function
Time Frame: Pre-intervention (T1) and immediately after the intervention (T2).
|
Cognitive function will be screened using Montreal Cognitive Assessment Hong Kong version (HK-MoCA).
|
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).
|
The World Health Organization Disability Assessment Schedule (WHODAS 2.0) is a widely used instrument for assessing disability and functioning in individuals.
|
Pre-intervention (T1) and immediately after the intervention (T2).
|
Collaborators and Investigators
Investigators
- Principal Investigator: Arkers KC Wong, PhD, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WZ8L
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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