Improving Post-acute Stroke Follow-up Care by Adopting Telecare Consultations in a Nurse-led Clinic

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Stroke

Intervention / Treatment
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* Procedure: Telecare consultation
* Procedure: Usual face-to-face consultation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants will receive three tertiary stroke care consultations provided by stroke nurses via telecare in 3 months. | Procedure: Telecare consultation<br>* Using Zoom to communicate with patients<br>|
| Placebo Comparator: Control group<br>Participants will receive three usual face-to-face consultations provided by stroke nurses in 3 months | Procedure: Usual face-to-face consultation<br>* Face-to-face communication with patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chang in Degree of disability after stroke | 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 | 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. | 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 | 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 | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, telecare consultation