- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05183672
Improving Post-acute Stroke Follow-up Care by Adopting Telecare Consultations in a Nurse-led Clinic
September 8, 2025 updated by: Arkers, Wong, The Hong Kong Polytechnic University
Improving Post-acute Stroke Follow-up Care by Adopting Telecare Consultations in a Nurse-led Clinic During COVID-19 and Beyond: A Hybrid Type 2 Implementation-effectiveness Randomized Trial
Since 2017, Hong Kong has provided post-acute stroke services in clinics operated by stroke advanced practice nurses (APNs).
Currently, the applicability of the clinics has been further limited by the emergence of the coronavirus (COVID-19) pandemic due to restrictions on visits to the clinics and tightened social distancing requirements.
Telecare consultations may be a viable option for contributing more flexible, interactive, and cost-efficient care models to support stroke survivors over the longer run.
The present study takes advantage of this opportunity by utilizing implementation science to simultaneously implement and evaluate a telecare model of care in a nurse-led post-acute stroke clinic.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
196
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arkers Wong, Ph.D.
- Phone Number: 85234003805
- Email: arkers.wong@polyu.edu.hk
Study Locations
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-
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Kowloon, Hong Kong
- Recruiting
- Queen Elizabeth Hospital
-
Contact:
- Wai Yan Kwok
- Phone Number: 85235067349
- Email: bkwyv02@ha.org.hk
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- confirmed diagnosis of stroke within 1 month before enrolment, will be discharged home within a week, aged 18 or above, cognitively competent with a score equal to or greater than 22 in the Montreal Cognitive Assessment Hong Kong version, own a smartphone
Exclusion Criteria:
- have unaccompanied hearing or vision loss, cannot be reached by phone, bedbound, have no Internet connection at home, participating in other clinical trials at the same time, require physical contact, i.e. wound dressing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Participants will receive three tertiary stroke care consultations provided by stroke nurses via telecare in 3 months.
|
Using Zoom to communicate with patients
|
|
Placebo Comparator: Control group
Participants will receive three usual face-to-face consultations provided by stroke nurses in 3 months
|
Face-to-face communication with patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chang in Degree of disability after stroke
Time Frame: baseline, three months when the program is completed, three months after the program is completed.
|
Simplified modified Rankin scale will be used to measure the degree of disability for stroke patients.
The scale has three questions to identify whether the patient has a score from 0 to 5, with higher scores representing higher degree of disability.
|
baseline, three months when the program is completed, three months after the program is completed.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of the recurrence of stroke
Time Frame: baseline, three months when the program is completed, three months after the program is completed.
|
The percentage of participants who re-admitted to hospital because of recurrent stroke
|
baseline, three months when the program is completed, three months after the program is completed.
|
|
Change of Quality of life, which measures an individual perception oftheir position in life. It includes physical and mental health.
Time Frame: baseline, three months when the program is completed, three months after the program is completed.
|
Quality of life will be measured using the Hong Kong version of EuroQol 5-dimension.
The scale has five subdomains, which include mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Since the scale has 5 items, each digit in the five digit codes refers to the status of each dimension, ranging from 1 for no problem, to 5 for sever problem.
A higher scores indicate better quality of life.
|
baseline, three months when the program is completed, three months after the program is completed.
|
|
Change of Post-stroke depression
Time Frame: baseline, three months when the program is completed, three months after the program is completed.
|
Post-stroke depression will be measured using the Chinese version of the Geriatric Depression scale.
This scale has a minimum score of 0 and a maximum score of 15.
Lower scores represent lower depression level.
|
baseline, three months when the program is completed, three months after the program is completed.
|
|
Change of Medication adherence
Time Frame: baseline, three months when the program is completed, three months after the program is completed.
|
Medication adherence will be determined using the Adherence to Refills and Medications Scale.
The scale produces an overall adherence score of 10-40, with lower scores indicating better adherence.
|
baseline, three months when the program is completed, three months after the program is completed.
|
|
Change of Social participation
Time Frame: baseline, three months when the program is completed, three months after the program is completed.
|
Social participation will be measured using the 11-item Reintegration to Normal Living index.
This scale is used to measure whether the patient has participated in several social activities before and after occurrence of stroke.
The scale yields total score from 0-22, with higher scores indicating poorer social participation.
|
baseline, three months when the program is completed, three months after the program is completed.
|
|
Number of attendances at a general practitioners' office, emergency department, hospital, and general out-patient clinic
Time Frame: baseline, three months when the program is completed, three months after the program is completed.
|
To measure the utilization of healthcare services by stroke patient before and after the intervention
|
baseline, three months when the program is completed, three months after the program is completed.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost effectiveness of the program
Time Frame: baseline, three months when the program is completed, three months after the program is completed.
|
Cost and quality-adjusted life years will be collected at baseline, three months when the program is completed, and three months after the program is completed.
Incremental cost-effectiveness ratios between the groups will be calculated by dividing the difference in cost by the difference in quality-adjusted life years.
|
baseline, three months when the program is completed, three months after the program is completed.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Arkers Wong, Ph.D., The Hong Kong Polytechnic University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2022
Primary Completion (Estimated)
October 30, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
December 7, 2021
First Submitted That Met QC Criteria
January 5, 2022
First Posted (Actual)
January 10, 2022
Study Record Updates
Last Update Posted (Estimated)
September 10, 2025
Last Update Submitted That Met QC Criteria
September 8, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A0036516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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