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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Telecare consultation
Usual face-to-face consultation
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring stroke, telecare consultation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Elizabeth HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

Participants will receive three tertiary stroke care consultations provided by stroke nurses via telecare in 3 months.

Participants will receive three usual face-to-face consultations provided by stroke nurses in 3 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of the recurrence of stroke
The percentage of participants who re-admitted to hospital because of recurrent stroke
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.
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.
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.
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.
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

Full Information

First Posted
December 7, 2021
Last Updated
March 2, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
The Queen Elizabeth Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05183672
Brief Title
Improving Post-acute Stroke Follow-up Care by Adopting Telecare Consultations in a Nurse-led Clinic
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
The Queen Elizabeth Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, telecare consultation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants will receive three tertiary stroke care consultations provided by stroke nurses via telecare in 3 months.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants will receive three usual face-to-face consultations provided by stroke nurses in 3 months
Intervention Type
Procedure
Intervention Name(s)
Telecare consultation
Intervention Description
Using Zoom to communicate with patients
Intervention Type
Procedure
Intervention Name(s)
Usual face-to-face consultation
Intervention Description
Face-to-face communication with patients
Primary Outcome Measure Information:
Title
Chang in Degree of disability after stroke
Description
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.
Time Frame
baseline, three months when the program is completed, three months after the program is completed.
Secondary Outcome Measure Information:
Title
Incidence of the recurrence of stroke
Description
The percentage of participants who re-admitted to hospital because of recurrent stroke
Time Frame
baseline, three months when the program is completed, three months after the program is completed.
Title
Change of Quality of life, which measures an individual perception oftheir position in life. It includes physical and mental health.
Description
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.
Time Frame
baseline, three months when the program is completed, three months after the program is completed.
Title
Change of Post-stroke depression
Description
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.
Time Frame
baseline, three months when the program is completed, three months after the program is completed.
Title
Change of Medication adherence
Description
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.
Time Frame
baseline, three months when the program is completed, three months after the program is completed.
Title
Change of Social participation
Description
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.
Time Frame
baseline, three months when the program is completed, three months after the program is completed.
Title
Number of attendances at a general practitioners' office, emergency department, hospital, and general out-patient clinic
Description
To measure the utilization of healthcare services by stroke patient before and after the intervention
Time Frame
baseline, three months when the program is completed, three months after the program is completed.
Other Pre-specified Outcome Measures:
Title
Cost effectiveness of the program
Description
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.
Time Frame
baseline, three months when the program is completed, three months after the program is completed.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arkers Wong, Ph.D.
Phone
85234003805
Email
arkers.wong@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arkers Wong, Ph.D.
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Hospital
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wai Yan Kwok
Phone
85235067349
Email
bkwyv02@ha.org.hk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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