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Telecare Consultation in Nurse-led Post-acute Stroke Clinic

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
telecare consultation
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring stroke, telecare consultation, nurse clinic

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
  • 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 Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

The participants will receive two tertiary stroke care consultations provided by stroke nurses via telecare in 2 months.

Outcomes

Primary Outcome Measures

Degree of disability after stroke
Simplified modified Rankin scale will be used to measure the degree of disability for stroke patients.

Secondary Outcome Measures

Quality of life
Quality of life will be measured using the Hong Kong version of EuroQol 5-dimension (EQ-5D-5L).
Post-stroke depression
Post-stroke depression will be measured using the Chinese version of the Geriatric Depression Scale
Medication adherence
Medication adherence will be determined using the Adherence to Refills and Medications Scale (ARMS).
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.
Number of attendances at a general practitioner's 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
October 6, 2021
Last Updated
September 20, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
The Queen Elizabeth Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05081570
Brief Title
Telecare Consultation in Nurse-led Post-acute Stroke Clinic
Official Title
A Pilot Study to Evaluate the Feasibility and Effectiveness of Telecare Consultation in Nurse-led Post-acute Stroke Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 30, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
July 30, 2023 (Actual)

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

5. Study Description

Brief Summary
Introduction: The progress of stroke recovery is slow and enduring. If stroke survivors are not properly managed to facilitate their rehabilitation after discharged from hospital, their risk for recurrence after an index stroke will be very high. Globally, nurse-led post-acute stroke clinics have been developed to provide tertiary care services to support stroke survivors. While synthesized evidence supports the idea that the post-stroke services delivered by nurses in the clinic can improve the functional ability and reduce the readmission rate, shortcomings of these services such as compulsory traveling time and cost, long waiting time at the clinic, and the pandemic situation limit the clinic utilization by stroke survivors. Telecare consultation is a new modality aiming to provide a new healthcare access experience to the public, though how it can be applied in nurse-led clinic and what effects it can bring about on post-stroke survivors has not been reported.
Detailed Description
The aim of this pilot study is to determine the feasibility and effectiveness of telecare consultation in nurse-led post-acute stroke clinic. Method: The present pilot study adopts a one-group pre-test post-test design. The potential subjects will be recruited from the clinic in Queen Elizabeth Hospital if they are (1) having a confirmed diagnosis of stroke within 1 month before enrolment, (2) referred to nurse-led post-acute stroke clinic, (3) aged 18 or above, (4) cognitively competent with a score ≥ 22 in the Montreal Cognitive Assessment Hong Kong version, (5) living at home before and after discharged from the acute stroke unit, and (6) having a smartphone or living with family member who has a smartphone. The participants will receive two tertiary stroke care consultations provided by stroke nurses via telecare in 2 months. The outcome measures include feasibility (reasons for refusal and drop-out, acceptance and satisfaction of both the advanced practising nurses and their patients towards the program), and effectiveness (degree of disability after stroke, activity of daily living, instrumental activity of daily living, health-related quality of life, depression). Data will be collected at pre- (T1) and post- (T2) intervention. Discussion: The findings of this pilot study can provide a preliminary evidence on the use of telecare consultation in the nurse-led post-acute stroke clinic including its feasibility and effectiveness on both providers and patients. When gaps are identified, they could be adjusted to help develop and design a definitive, large-scale randomized controlled trial.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
No masking is needed
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The participants will receive two tertiary stroke care consultations provided by stroke nurses via telecare in 2 months.
Intervention Type
Device
Intervention Name(s)
telecare consultation
Intervention Description
Two tertiary stroke care consultations will be provided by stroke nurses via telecare in 2 months. Consultation content includes provide education on modifying stroke-specific risk factors, disseminate self-management knowledge, reinforce the importance of medication compliance, revise the blood and investigation results, and co-design and follow-up on mutually agreed rehabilitation goals with the subjects. When necessary, the nurse will also refer the stroke survivors to multidisciplinary team members according to the referral guidelines. The nurse will also encourage the patients' family and/or informal caregivers to participate in the consultations.
Primary Outcome Measure Information:
Title
Degree of disability after stroke
Description
Simplified modified Rankin scale will be used to measure the degree of disability for stroke patients.
Time Frame
baseline, three months when the program is completed
Secondary Outcome Measure Information:
Title
Quality of life
Description
Quality of life will be measured using the Hong Kong version of EuroQol 5-dimension (EQ-5D-5L).
Time Frame
baseline, three months when the program is completed
Title
Post-stroke depression
Description
Post-stroke depression will be measured using the Chinese version of the Geriatric Depression Scale
Time Frame
baseline, three months when the program is completed
Title
Medication adherence
Description
Medication adherence will be determined using the Adherence to Refills and Medications Scale (ARMS).
Time Frame
baseline, three months when the program is completed
Title
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.
Time Frame
baseline, three months when the program is completed
Title
Number of attendances at a general practitioner's 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
Other Pre-specified Outcome Measures:
Title
Number of patients who are eligible, excluded, recruited, and completed.
Description
To assess the feasibility of the program to the stroke patients
Time Frame
three months when the program is completed
Title
IT literacy
Description
IT literacy will be assessed by answering the question, "How confident are you in using a smartphone to have meetings with others?" using a 5-point scale where 1=not very confident, and 5=very confident.
Time Frame
baseline, three months when the program is completed
Title
the success of the adoption of telecare consultation
Description
the Readiness for Implementation Model Survey will be used to evaluate the success of the adoption of telecare consultation at the staff and clinic level. This 42-item survey centers on attitudes, organizational environment, technology usefulness factors, and implementation process factors.
Time Frame
three months when 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 no Internet connection at home participating in other clinical trials at the same time require physical contact, i.e. wound dressing
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

12. IPD Sharing Statement

Plan to Share IPD
No

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Telecare Consultation in Nurse-led Post-acute Stroke Clinic

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