A Dual-Modality Home-Based Cardiac Rehabilitation Program for Adults With Cardiovascular Disease: Single-Arm Remote Clinical Trial
Cardiac rehabilitation (CR) is a safe, effective intervention for individuals with cardiovascular disease (CVD). However, a majority of eligible patients do not complete CR. Growing evidence suggests that home-based cardiac rehabilitation (HBCR) programs are comparable in effectiveness and safety wi...
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          | Published in | JMIR mHealth and uHealth Vol. 12; p. e59098 | 
|---|---|
| Main Authors | , , , , , , , , , , , | 
| Format | Journal Article | 
| Language | English | 
| Published | 
        Canada
          JMIR Publications
    
        01.10.2024
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| Subjects | |
| Online Access | Get full text | 
| ISSN | 2291-5222 2291-5222  | 
| DOI | 10.2196/59098 | 
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| Abstract | Cardiac rehabilitation (CR) is a safe, effective intervention for individuals with cardiovascular disease (CVD). However, a majority of eligible patients do not complete CR. Growing evidence suggests that home-based cardiac rehabilitation (HBCR) programs are comparable in effectiveness and safety with traditional center-based programs. More research is needed to explore different ways to deliver HBCR programs to patients with CVD.
We aimed to assess the feasibility and impact of a digital HBCR program (RecoveryPlus.Health) that integrates both telehealth and mHealth modalities on functional exercise capacity, resting heart rate, and quality of life among adults with CVD.
This 12-week prospective, single-arm remote clinical trial used a within-subject design. We recruited adults with CVD (aged ≥40 years) from the community with a CR-eligible diagnosis (stable angina pectoris, myocardial infarction, and heart failure) between May and August 2023. All enrolled patients referred to the RPH clinic in Roanoke, Texas, were included. The care team provided guideline-concordant CR services to study participants via two modalities: (1) a synchronous telehealth exercise training through videoconferencing; and (2) an asynchronous mobile health (mHealth) coaching app (RPH app). Baseline intake survey, electronic health record, and app log data were used to extract individual characteristics, care processes, and platform engagement data. Feasibility was measured by program completion rate and CR service use. Efficacy was measured by changes in the 6-minute walk test, resting heart rate, and quality of life (12-Item Short-Form Health Survey) before and after the 12-week program. Paired t tests were used to examine pre- and postintervention changes in the outcome variables.
In total, 162 met the inclusion criteria and 75 (46.3%) consented and were enrolled (mean age 64, SD 10.30 years; male: n=37, 49%; White: n=46, 61%). Heart failure was the most common diagnosis (37/75, 49%). In total, 62/75 (83%) participants completed the 12-week study and used the telehealth modality with 9.63 (SD 3.33) sessions completed, and 59/75 (79%) used the mHealth modality with 10.97 (SD 11.70) sessions completed. Post intervention, 50/62 (81%) participants' performance in the 6-minute walk test had improved, with an average improvement of 40 (SD 63.39) m (95% CI 25.6-57.1). The average 12-Item Short-Form Health Survey's physical and mental summary scores improved by 2.7 (SD 6.47) points (95% CI 1.1-4.3) and 2.2 (SD 9.09) points (95% CI 0.1-4.5), respectively. There were no changes in resting heart rate and no exercise-related adverse events were reported.
The RecoveryPlus.Health digital HBCR program showed feasibility and efficacy in a group of nationally recruited patients with CVD. The findings add to the evidence that a telehealth and mHealth dual-modality HBCR program may be a promising approach to overcome some of the main barriers to improving CR access in the United States.
ClinicalTrials.gov NCT05804500; https://clinicaltrials.gov/search?cond=NCT05804500. | 
    
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| AbstractList | Background:Cardiac rehabilitation (CR) is a safe, effective intervention for individuals with cardiovascular disease (CVD). However, a majority of eligible patients do not complete CR. Growing evidence suggests that home-based cardiac rehabilitation (HBCR) programs are comparable in effectiveness and safety with traditional center-based programs. More research is needed to explore different ways to deliver HBCR programs to patients with CVD.Objective:We aimed to assess the feasibility and impact of a digital HBCR program (RecoveryPlus.Health) that integrates both telehealth and mHealth modalities on functional exercise capacity, resting heart rate, and quality of life among adults with CVD.Methods:This 12-week prospective, single-arm remote clinical trial used a within-subject design. We recruited adults with CVD (aged ≥40 years) from the community with a CR-eligible diagnosis (stable angina pectoris, myocardial infarction, and heart failure) between May and August 2023. All enrolled patients referred to the RPH clinic in Roanoke, Texas, were included. The care team provided guideline-concordant CR services to study participants via two modalities: (1) a synchronous telehealth exercise training through videoconferencing; and (2) an asynchronous mobile health (mHealth) coaching app (RPH app). Baseline intake survey, electronic health record, and app log data were used to extract individual characteristics, care processes, and platform engagement data. Feasibility was measured by program completion rate and CR service use. Efficacy was measured by changes in the 6-minute walk test, resting heart rate, and quality of life (12-Item Short-Form Health Survey) before and after the 12-week program. Paired t tests were used to examine pre- and postintervention changes in the outcome variables.Results:In total, 162 met the inclusion criteria and 75 (46.3%) consented and were enrolled (mean age 64, SD 10.30 years; male: n=37, 49%; White: n=46, 61%). Heart failure was the most common diagnosis (37/75, 49%). In total, 62/75 (83%) participants completed the 12-week study and used the telehealth modality with 9.63 (SD 3.33) sessions completed, and 59/75 (79%) used the mHealth modality with 10.97 (SD 11.70) sessions completed. Post intervention, 50/62 (81%) participants’ performance in the 6-minute walk test had improved, with an average improvement of 40 (SD 63.39) m (95% CI 25.6-57.1). The average 12-Item Short-Form Health Survey’s physical and mental summary scores improved by 2.7 (SD 6.47) points (95% CI 1.1-4.3) and 2.2 (SD 9.09) points (95% CI 0.1-4.5), respectively. There were no changes in resting heart rate and no exercise-related adverse events were reported.Conclusions:The RecoveryPlus.Health digital HBCR program showed feasibility and efficacy in a group of nationally recruited patients with CVD. The findings add to the evidence that a telehealth and mHealth dual-modality HBCR program may be a promising approach to overcome some of the main barriers to improving CR access in the United States.Trial Registration:ClinicalTrials.gov NCT05804500; https://clinicaltrials.gov/search?cond=NCT05804500 Cardiac rehabilitation (CR) is a safe, effective intervention for individuals with cardiovascular disease (CVD). However, a majority of eligible patients do not complete CR. Growing evidence suggests that home-based cardiac rehabilitation (HBCR) programs are comparable in effectiveness and safety with traditional center-based programs. More research is needed to explore different ways to deliver HBCR programs to patients with CVD.BACKGROUNDCardiac rehabilitation (CR) is a safe, effective intervention for individuals with cardiovascular disease (CVD). However, a majority of eligible patients do not complete CR. Growing evidence suggests that home-based cardiac rehabilitation (HBCR) programs are comparable in effectiveness and safety with traditional center-based programs. More research is needed to explore different ways to deliver HBCR programs to patients with CVD.We aimed to assess the feasibility and impact of a digital HBCR program (RecoveryPlus.Health) that integrates both telehealth and mHealth modalities on functional exercise capacity, resting heart rate, and quality of life among adults with CVD.OBJECTIVEWe aimed to assess the feasibility and impact of a digital HBCR program (RecoveryPlus.Health) that integrates both telehealth and mHealth modalities on functional exercise capacity, resting heart rate, and quality of life among adults with CVD.This 12-week prospective, single-arm remote clinical trial used a within-subject design. We recruited adults with CVD (aged ≥40 years) from the community with a CR-eligible diagnosis (stable angina pectoris, myocardial infarction, and heart failure) between May and August 2023. All enrolled patients referred to the RPH clinic in Roanoke, Texas, were included. The care team provided guideline-concordant CR services to study participants via two modalities: (1) a synchronous telehealth exercise training through videoconferencing; and (2) an asynchronous mobile health (mHealth) coaching app (RPH app). Baseline intake survey, electronic health record, and app log data were used to extract individual characteristics, care processes, and platform engagement data. Feasibility was measured by program completion rate and CR service use. Efficacy was measured by changes in the 6-minute walk test, resting heart rate, and quality of life (12-Item Short-Form Health Survey) before and after the 12-week program. Paired t tests were used to examine pre- and postintervention changes in the outcome variables.METHODSThis 12-week prospective, single-arm remote clinical trial used a within-subject design. We recruited adults with CVD (aged ≥40 years) from the community with a CR-eligible diagnosis (stable angina pectoris, myocardial infarction, and heart failure) between May and August 2023. All enrolled patients referred to the RPH clinic in Roanoke, Texas, were included. The care team provided guideline-concordant CR services to study participants via two modalities: (1) a synchronous telehealth exercise training through videoconferencing; and (2) an asynchronous mobile health (mHealth) coaching app (RPH app). Baseline intake survey, electronic health record, and app log data were used to extract individual characteristics, care processes, and platform engagement data. Feasibility was measured by program completion rate and CR service use. Efficacy was measured by changes in the 6-minute walk test, resting heart rate, and quality of life (12-Item Short-Form Health Survey) before and after the 12-week program. Paired t tests were used to examine pre- and postintervention changes in the outcome variables.In total, 162 met the inclusion criteria and 75 (46.3%) consented and were enrolled (mean age 64, SD 10.30 years; male: n=37, 49%; White: n=46, 61%). Heart failure was the most common diagnosis (37/75, 49%). In total, 62/75 (83%) participants completed the 12-week study and used the telehealth modality with 9.63 (SD 3.33) sessions completed, and 59/75 (79%) used the mHealth modality with 10.97 (SD 11.70) sessions completed. Post intervention, 50/62 (81%) participants' performance in the 6-minute walk test had improved, with an average improvement of 40 (SD 63.39) m (95% CI 25.6-57.1). The average 12-Item Short-Form Health Survey's physical and mental summary scores improved by 2.7 (SD 6.47) points (95% CI 1.1-4.3) and 2.2 (SD 9.09) points (95% CI 0.1-4.5), respectively. There were no changes in resting heart rate and no exercise-related adverse events were reported.RESULTSIn total, 162 met the inclusion criteria and 75 (46.3%) consented and were enrolled (mean age 64, SD 10.30 years; male: n=37, 49%; White: n=46, 61%). Heart failure was the most common diagnosis (37/75, 49%). In total, 62/75 (83%) participants completed the 12-week study and used the telehealth modality with 9.63 (SD 3.33) sessions completed, and 59/75 (79%) used the mHealth modality with 10.97 (SD 11.70) sessions completed. Post intervention, 50/62 (81%) participants' performance in the 6-minute walk test had improved, with an average improvement of 40 (SD 63.39) m (95% CI 25.6-57.1). The average 12-Item Short-Form Health Survey's physical and mental summary scores improved by 2.7 (SD 6.47) points (95% CI 1.1-4.3) and 2.2 (SD 9.09) points (95% CI 0.1-4.5), respectively. There were no changes in resting heart rate and no exercise-related adverse events were reported.The RecoveryPlus.Health digital HBCR program showed feasibility and efficacy in a group of nationally recruited patients with CVD. The findings add to the evidence that a telehealth and mHealth dual-modality HBCR program may be a promising approach to overcome some of the main barriers to improving CR access in the United States.CONCLUSIONSThe RecoveryPlus.Health digital HBCR program showed feasibility and efficacy in a group of nationally recruited patients with CVD. The findings add to the evidence that a telehealth and mHealth dual-modality HBCR program may be a promising approach to overcome some of the main barriers to improving CR access in the United States.ClinicalTrials.gov NCT05804500; https://clinicaltrials.gov/search?cond=NCT05804500.TRIAL REGISTRATIONClinicalTrials.gov NCT05804500; https://clinicaltrials.gov/search?cond=NCT05804500. Cardiac rehabilitation (CR) is a safe, effective intervention for individuals with cardiovascular disease (CVD). However, a majority of eligible patients do not complete CR. Growing evidence suggests that home-based cardiac rehabilitation (HBCR) programs are comparable in effectiveness and safety with traditional center-based programs. More research is needed to explore different ways to deliver HBCR programs to patients with CVD. We aimed to assess the feasibility and impact of a digital HBCR program (RecoveryPlus.Health) that integrates both telehealth and mHealth modalities on functional exercise capacity, resting heart rate, and quality of life among adults with CVD. This 12-week prospective, single-arm remote clinical trial used a within-subject design. We recruited adults with CVD (aged ≥40 years) from the community with a CR-eligible diagnosis (stable angina pectoris, myocardial infarction, and heart failure) between May and August 2023. All enrolled patients referred to the RPH clinic in Roanoke, Texas, were included. The care team provided guideline-concordant CR services to study participants via two modalities: (1) a synchronous telehealth exercise training through videoconferencing; and (2) an asynchronous mobile health (mHealth) coaching app (RPH app). Baseline intake survey, electronic health record, and app log data were used to extract individual characteristics, care processes, and platform engagement data. Feasibility was measured by program completion rate and CR service use. Efficacy was measured by changes in the 6-minute walk test, resting heart rate, and quality of life (12-Item Short-Form Health Survey) before and after the 12-week program. Paired t tests were used to examine pre- and postintervention changes in the outcome variables. In total, 162 met the inclusion criteria and 75 (46.3%) consented and were enrolled (mean age 64, SD 10.30 years; male: n=37, 49%; White: n=46, 61%). Heart failure was the most common diagnosis (37/75, 49%). In total, 62/75 (83%) participants completed the 12-week study and used the telehealth modality with 9.63 (SD 3.33) sessions completed, and 59/75 (79%) used the mHealth modality with 10.97 (SD 11.70) sessions completed. Post intervention, 50/62 (81%) participants' performance in the 6-minute walk test had improved, with an average improvement of 40 (SD 63.39) m (95% CI 25.6-57.1). The average 12-Item Short-Form Health Survey's physical and mental summary scores improved by 2.7 (SD 6.47) points (95% CI 1.1-4.3) and 2.2 (SD 9.09) points (95% CI 0.1-4.5), respectively. There were no changes in resting heart rate and no exercise-related adverse events were reported. The RecoveryPlus.Health digital HBCR program showed feasibility and efficacy in a group of nationally recruited patients with CVD. The findings add to the evidence that a telehealth and mHealth dual-modality HBCR program may be a promising approach to overcome some of the main barriers to improving CR access in the United States. ClinicalTrials.gov NCT05804500; https://clinicaltrials.gov/search?cond=NCT05804500. BackgroundCardiac rehabilitation (CR) is a safe, effective intervention for individuals with cardiovascular disease (CVD). However, a majority of eligible patients do not complete CR. Growing evidence suggests that home-based cardiac rehabilitation (HBCR) programs are comparable in effectiveness and safety with traditional center-based programs. More research is needed to explore different ways to deliver HBCR programs to patients with CVD. ObjectiveWe aimed to assess the feasibility and impact of a digital HBCR program (RecoveryPlus.Health) that integrates both telehealth and mHealth modalities on functional exercise capacity, resting heart rate, and quality of life among adults with CVD. MethodsThis 12-week prospective, single-arm remote clinical trial used a within-subject design. We recruited adults with CVD (aged ≥40 years) from the community with a CR-eligible diagnosis (stable angina pectoris, myocardial infarction, and heart failure) between May and August 2023. All enrolled patients referred to the RPH clinic in Roanoke, Texas, were included. The care team provided guideline-concordant CR services to study participants via two modalities: (1) a synchronous telehealth exercise training through videoconferencing; and (2) an asynchronous mobile health (mHealth) coaching app (RPH app). Baseline intake survey, electronic health record, and app log data were used to extract individual characteristics, care processes, and platform engagement data. Feasibility was measured by program completion rate and CR service use. Efficacy was measured by changes in the 6-minute walk test, resting heart rate, and quality of life (12-Item Short-Form Health Survey) before and after the 12-week program. Paired t tests were used to examine pre- and postintervention changes in the outcome variables. ResultsIn total, 162 met the inclusion criteria and 75 (46.3%) consented and were enrolled (mean age 64, SD 10.30 years; male: n=37, 49%; White: n=46, 61%). Heart failure was the most common diagnosis (37/75, 49%). In total, 62/75 (83%) participants completed the 12-week study and used the telehealth modality with 9.63 (SD 3.33) sessions completed, and 59/75 (79%) used the mHealth modality with 10.97 (SD 11.70) sessions completed. Post intervention, 50/62 (81%) participants’ performance in the 6-minute walk test had improved, with an average improvement of 40 (SD 63.39) m (95% CI 25.6-57.1). The average 12-Item Short-Form Health Survey’s physical and mental summary scores improved by 2.7 (SD 6.47) points (95% CI 1.1-4.3) and 2.2 (SD 9.09) points (95% CI 0.1-4.5), respectively. There were no changes in resting heart rate and no exercise-related adverse events were reported. ConclusionsThe RecoveryPlus.Health digital HBCR program showed feasibility and efficacy in a group of nationally recruited patients with CVD. The findings add to the evidence that a telehealth and mHealth dual-modality HBCR program may be a promising approach to overcome some of the main barriers to improving CR access in the United States. Trial RegistrationClinicalTrials.gov NCT05804500; https://clinicaltrials.gov/search?cond=NCT05804500  | 
    
| Author | Chen, Xi Niemi, Samantha Bilbrey, Tim Bai, Changhao Chokshi, Sara Lei, Zhen Shah, Rishab Martin, Jenny Zhou, Wen Vaswani, Nitin Bhusri, Satjit Meng, Hongdao  | 
    
| AuthorAffiliation | 5 School of Aging Studies University of South Florida Tampa, FL United States 3 Upper East Side Cardiology PLLC New York, NY United States 4 McCormick School of Engineering Northwestern University Chicago, IL United States 1 RecoveryPlus.Health, Inc New York, NY United States 2 Node.Health Foundation Wilmington, DE United States  | 
    
| AuthorAffiliation_xml | – name: 3 Upper East Side Cardiology PLLC New York, NY United States – name: 2 Node.Health Foundation Wilmington, DE United States – name: 4 McCormick School of Engineering Northwestern University Chicago, IL United States – name: 5 School of Aging Studies University of South Florida Tampa, FL United States – name: 1 RecoveryPlus.Health, Inc New York, NY United States  | 
    
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/39150858$$D View this record in MEDLINE/PubMed | 
    
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| Copyright | Tim Bilbrey, Jenny Martin, Wen Zhou, Changhao Bai, Nitin Vaswani, Rishab Shah, Sara Chokshi, Xi Chen, Satjit Bhusri, Samantha Niemi, Hongdao Meng, Zhen Lei. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 01.10.2024. 2024. This work is licensed under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. Tim Bilbrey, Jenny Martin, Wen Zhou, Changhao Bai, Nitin Vaswani, Rishab Shah, Sara Chokshi, Xi Chen, Satjit Bhusri, Samantha Niemi, Hongdao Meng, Zhen Lei. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 01.10.2024. 2024  | 
    
| Copyright_xml | – notice: Tim Bilbrey, Jenny Martin, Wen Zhou, Changhao Bai, Nitin Vaswani, Rishab Shah, Sara Chokshi, Xi Chen, Satjit Bhusri, Samantha Niemi, Hongdao Meng, Zhen Lei. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 01.10.2024. – notice: 2024. This work is licensed under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. – notice: Tim Bilbrey, Jenny Martin, Wen Zhou, Changhao Bai, Nitin Vaswani, Rishab Shah, Sara Chokshi, Xi Chen, Satjit Bhusri, Samantha Niemi, Hongdao Meng, Zhen Lei. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 01.10.2024. 2024  | 
    
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| Keywords | app digital health application physical fitness telehealth myocardial infarction mHealth exercise quality of life self-management cardiac rehabilitation disease management  | 
    
| Language | English | 
    
| License | Tim Bilbrey, Jenny Martin, Wen Zhou, Changhao Bai, Nitin Vaswani, Rishab Shah, Sara Chokshi, Xi Chen, Satjit Bhusri, Samantha Niemi, Hongdao Meng, Zhen Lei. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 01.10.2024. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mHealth and uHealth, is properly cited. The complete bibliographic information, a link to the original publication on https://mhealth.jmir.org/, as well as this copyright and license information must be included. cc-by  | 
    
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| Snippet | Cardiac rehabilitation (CR) is a safe, effective intervention for individuals with cardiovascular disease (CVD). However, a majority of eligible patients do... Background:Cardiac rehabilitation (CR) is a safe, effective intervention for individuals with cardiovascular disease (CVD). However, a majority of eligible... BackgroundCardiac rehabilitation (CR) is a safe, effective intervention for individuals with cardiovascular disease (CVD). However, a majority of eligible...  | 
    
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| SubjectTerms | Adult Aged Angina pectoris Cardiac Rehabilitation - methods Cardiac Rehabilitation - statistics & numerical data Cardiovascular disease Cardiovascular Diseases Clinical trials Enrollments Ethnicity Exercise Female Fitness training programs Health Insurance Portability & Accountability Act 1996-US Heart rate Home Care Services - standards Home Care Services - statistics & numerical data Humans Male Middle Aged Mortality Original Paper Patients Physical fitness Prospective Studies Quality of life Quality of Life - psychology Rehabilitation Remote searching Telemedicine Telemedicine - statistics & numerical data Texas  | 
    
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| Title | A Dual-Modality Home-Based Cardiac Rehabilitation Program for Adults With Cardiovascular Disease: Single-Arm Remote Clinical Trial | 
    
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