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 inJMIR mHealth and uHealth Vol. 12; p. e59098
Main Authors Bilbrey, Tim, Martin, Jenny, Zhou, Wen, Bai, Changhao, Vaswani, Nitin, Shah, Rishab, Chokshi, Sara, Chen, Xi, Bhusri, Satjit, Niemi, Samantha, Meng, Hongdao, Lei, Zhen
Format Journal Article
LanguageEnglish
Published Canada JMIR Publications 01.10.2024
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Online AccessGet full text
ISSN2291-5222
2291-5222
DOI10.2196/59098

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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.
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
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– 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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ContentType Journal Article
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.
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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
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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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