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The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure. (SHCR-HF)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
smartphone-assisted hybrid cardiac rehabilitation (SHCR)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring cardiac rehabilitation, heart failure, eHealth

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with heart failure between the ages of 18 and 80 years old. NYHA (New York Heart Association) functional classification of 1 to 3. Patients must be in a stable condition and under outpatient follow-up. Exclusion Criteria: Patients who have contraindications for exercise according to the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription. Patients who are unable to complete cardiopulmonary exercise testing. Patients who are unable to follow verbal instructions. Patients who are unable to walk independently or pedal a stationary bicycle. Patients who are unable to use communication app on a smartphone. Patients who already engage in physical activity exceeding the recommended moderate intensity of 150 minutes per week or are currently participating in cardiac rehabilitation. Patients who do not provide consent to participate in the trial.

Sites / Locations

  • Department of Physical Medicine and Rehabilitation, National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

smartphone-assisted hybrid cardiac rehabilitation (SHCR)

Usual care

Arm Description

Participants receive a 12-wk case manager-led smartphone-assisted hybrid cardiac rehabilitation with follow-up at 12 week and 6 months.

Participants receive usual care including general education and exercise suggestion.

Outcomes

Primary Outcome Measures

Change of peak oxygen uptake
Peak oxygen uptake will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 6 months.
Change of 6 minute walking test
6 minute walking test will be performed before intervention, at 12 weeks (post-intervention), and at 6 months.

Secondary Outcome Measures

Adherence to prescribed exercise
We will evaluate the percentage of completed prescribed exercises at 12 weeks.
Evaluation of Quality of life
The investigators will assess the change in 36-Item Short Form Survey(SF-36).
Depression
The investigators will assess the change in Patient Health Questionnaire (PHQ-9). The PHQ-9 score ranges from 0-27. Higher scores indicate worsen symptoms.
Anxiety
The investigators will assess the change in Generalized Anxiety Disorder scale (GAD-7). The GAD-7 score ranges 0-21. Higher scores indicate worsen symptoms.
Evaluation of physical activity
The investigators will assess the change in physical activity using International Physical Activity Questionnaire(IPAQ) Taiwan version.
Evaluation of grip strength
The grip strength will be measured using a grip goniometer with the participants seated and the elbow flexed at 90 degrees.
Evaluation of frailty
The investigators will evaluate the change in the Clinical Frailty Scale, which ranges from 1 to 9. Higher scores represent greater illness.
Blood test: Total cholesterol
The Total cholesterol will be tested in the laboratory.
Blood test: LDL
The LDL will be tested in the laboratory.
Blood test: HDL
The HDL will be tested in the laboratory.
Blood test: Triglyceride
The Triglyceride will be tested in the laboratory.
Blood test: NT-proBNP
The NT-proBNP will be tested in the laboratory.

Full Information

First Posted
May 1, 2023
Last Updated
May 15, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05873543
Brief Title
The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.
Acronym
SHCR-HF
Official Title
The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University 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
The aim of this randomized controlled trial is to compare the impact of a case manager-led smartphone-assisted hybrid cardiac rehabilitation program with usual care in patients with HF. Participants will undergo a 12-week program led by a case manager and assisted by a smartphone. The study aims to answer two main questions: Is the novel cardiac rehabilitation model feasible for patients with HF? Does the intervention group show a significant improvement in exercise capacity and adherence compared to the usual care group?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
cardiac rehabilitation, heart failure, eHealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
smartphone-assisted hybrid cardiac rehabilitation (SHCR)
Arm Type
Experimental
Arm Description
Participants receive a 12-wk case manager-led smartphone-assisted hybrid cardiac rehabilitation with follow-up at 12 week and 6 months.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants receive usual care including general education and exercise suggestion.
Intervention Type
Other
Intervention Name(s)
smartphone-assisted hybrid cardiac rehabilitation (SHCR)
Intervention Description
The 12-week case manager-led SHCR program includes: Customized exercise prescriptions following ACSM's heart failure guidelines. A hybrid program combining in-person sessions, home self-exercise, and videoconferencing for exercise coaching(optional), supported by a smartphone app. Case managers instruct patients on a communication app for weekly follow-ups, health education messages, exercise reminders, and progress tracking, including metrics like blood pressure, heart rate, weight, and symptoms.
Primary Outcome Measure Information:
Title
Change of peak oxygen uptake
Description
Peak oxygen uptake will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 6 months.
Time Frame
at baseline, 12 weeks(post-intervention), and 6 months.
Title
Change of 6 minute walking test
Description
6 minute walking test will be performed before intervention, at 12 weeks (post-intervention), and at 6 months.
Time Frame
at baseline, 12 weeks(post-intervention), and 6 months.
Secondary Outcome Measure Information:
Title
Adherence to prescribed exercise
Description
We will evaluate the percentage of completed prescribed exercises at 12 weeks.
Time Frame
12 weeks(post-intervention)
Title
Evaluation of Quality of life
Description
The investigators will assess the change in 36-Item Short Form Survey(SF-36).
Time Frame
at baseline, 12 weeks(post-intervention), and 6 months.
Title
Depression
Description
The investigators will assess the change in Patient Health Questionnaire (PHQ-9). The PHQ-9 score ranges from 0-27. Higher scores indicate worsen symptoms.
Time Frame
at baseline, 12 weeks(post-intervention), and 6 months.
Title
Anxiety
Description
The investigators will assess the change in Generalized Anxiety Disorder scale (GAD-7). The GAD-7 score ranges 0-21. Higher scores indicate worsen symptoms.
Time Frame
at baseline, 12 weeks(post-intervention), and 6 months.
Title
Evaluation of physical activity
Description
The investigators will assess the change in physical activity using International Physical Activity Questionnaire(IPAQ) Taiwan version.
Time Frame
at baseline, 12 weeks(post-intervention), and 6 months.
Title
Evaluation of grip strength
Description
The grip strength will be measured using a grip goniometer with the participants seated and the elbow flexed at 90 degrees.
Time Frame
at baseline, 12 weeks(post-intervention), and 6 months.
Title
Evaluation of frailty
Description
The investigators will evaluate the change in the Clinical Frailty Scale, which ranges from 1 to 9. Higher scores represent greater illness.
Time Frame
at baseline, 12 weeks(post-intervention), and 6 months.
Title
Blood test: Total cholesterol
Description
The Total cholesterol will be tested in the laboratory.
Time Frame
at baseline, 12 weeks(post-intervention), and 6 months.
Title
Blood test: LDL
Description
The LDL will be tested in the laboratory.
Time Frame
at baseline, 12 weeks(post-intervention), and 6 months.
Title
Blood test: HDL
Description
The HDL will be tested in the laboratory.
Time Frame
at baseline, 12 weeks(post-intervention), and 6 months.
Title
Blood test: Triglyceride
Description
The Triglyceride will be tested in the laboratory.
Time Frame
at baseline, 12 weeks(post-intervention), and 6 months.
Title
Blood test: NT-proBNP
Description
The NT-proBNP will be tested in the laboratory.
Time Frame
at baseline, 12 weeks(post-intervention), and 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with heart failure between the ages of 18 and 80 years old. NYHA (New York Heart Association) functional classification of 1 to 3. Patients must be in a stable condition and under outpatient follow-up. Exclusion Criteria: Patients who have contraindications for exercise according to the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription. Patients who are unable to complete cardiopulmonary exercise testing. Patients who are unable to follow verbal instructions. Patients who are unable to walk independently or pedal a stationary bicycle. Patients who are unable to use communication app on a smartphone. Patients who already engage in physical activity exceeding the recommended moderate intensity of 150 minutes per week or are currently participating in cardiac rehabilitation. Patients who do not provide consent to participate in the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Jui Chuang, MD
Phone
00886-2-23123456
Ext
67034
Email
rexintwo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Jui Chuang, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Jui Chuang, MD
Phone
00886-2-23123456
Ext
67034
Email
rexintwo@gmail.com

12. IPD Sharing Statement

Learn more about this trial

The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.

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