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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183672
• Other study ID #: A0036516
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2023
• Source: The Hong Kong Polytechnic University
• Contact: Arkers Wong, Ph.D.
• Phone: 85234003805
• Email: arkers.wong[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Telecare consultation
Using Zoom to communicate with patients
• Usual face-to-face consultation
Face-to-face communication with patients

Locations

Country	Name	City	State
Hong Kong	Queen Elizabeth Hospital	Kowloon

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	The Queen Elizabeth Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost effectiveness of the program	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.