An Ecological Momentary Assessment Based Program to Support Self-Management for Post-stroke Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Ecological Momentary Assessment based Self-management Program
BehavioralThe 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Ecological Momentary Assessment based Self-management ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of the study: acceptance
The acceptance of participants to the program will be measured by recruitment rate, attrition rate, and retention rate.
Time frame
Immediately after the intervention (T2).2
Feasibility of the study: adherence
The adherence of the participants will be evaluated by using the percentage of completed EMA assessments and the frequency of app usage.
Time frame
Immediately after the intervention (T2).3
Feasibility of the study: experience of the participants in using the app
Participants' experience will be assessed through individual interviews.
Time frame
Immediately after the intervention (T2).Secondary outcomes
1
Preliminary effectiveness: depression Levels
Beck Depression Inventory (BDI) will be used to assess the depression levels of post-stroke patients.
Time frame
Pre-intervention (T1) and immediately after the intervention (T2).2
Preliminary effectiveness: cognitive function
Cognitive function will be screened using Montreal Cognitive Assessment Hong Kong version (HK-MoCA).
Time frame
Pre-intervention (T1) and immediately after the intervention (T2).3
Preliminary effectiveness: disability and functioning
The World Health Organization Disability Assessment Schedule (WHODAS 2.0) is a widely used instrument for assessing disability and functioning in individuals.
Time frame
Pre-intervention (T1) and immediately after the intervention (T2).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov