- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05081570
Telecare Consultation in Nurse-led Post-acute Stroke Clinic
A Pilot Study to Evaluate the Feasibility and Effectiveness of Telecare Consultation in Nurse-led Post-acute Stroke Clinic
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kowloon, Hong Kong
- Queen Elizabeth Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
- no Internet connection at home
- participating in other clinical trials at the same time
- require physical contact, i.e. wound dressing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention group
The participants will receive two tertiary stroke care consultations provided by stroke nurses via telecare in 2 months.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Degree of disability after stroke
Time Frame: baseline, three months when the program is completed
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Simplified modified Rankin scale will be used to measure the degree of disability for stroke patients.
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baseline, three months when the program is completed
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quality of life
Time Frame: baseline, three months when the program is completed
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Quality of life will be measured using the Hong Kong version of EuroQol 5-dimension (EQ-5D-5L).
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baseline, three months when the program is completed
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Post-stroke depression
Time Frame: baseline, three months when the program is completed
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Post-stroke depression will be measured using the Chinese version of the Geriatric Depression Scale
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baseline, three months when the program is completed
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Medication adherence
Time Frame: baseline, three months when the program is completed
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Medication adherence will be determined using the Adherence to Refills and Medications Scale (ARMS).
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baseline, three months when the program is completed
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Social participation
Time Frame: baseline, three months when the program is completed
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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.
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baseline, three months when the program is completed
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Number of attendances at a general practitioner's office, emergency department, hospital, and general out-patient clinic
Time Frame: baseline, three months when the program is completed
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To measure the utilization of healthcare services by stroke patient before and after the intervention.
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baseline, three months when the program is completed
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of patients who are eligible, excluded, recruited, and completed.
Time Frame: three months when the program is completed
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To assess the feasibility of the program to the stroke patients
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three months when the program is completed
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IT literacy
Time Frame: baseline, three months when the program is completed
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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.
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baseline, three months when the program is completed
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the success of the adoption of telecare consultation
Time Frame: three months when the program is completed
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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.
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three months when the program is completed
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Arkers Wong, Ph.D., The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P0035531
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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