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An Application of SMART Methodology to Optimize an Intervention to Maintain Improvements in Health Behaviors in Under-resourced Patients after Phase II Cardiac Rehabilitation

Award Number: R01HL171158
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2024
PERIOD OF PERFORMANCE END DATE: 04/30/2029

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An Application of SMART Methodology to Optimize an Intervention to Maintain Improvements in Health Behaviors in Under-resourced Patients after Phase II Cardiac Rehabilitation - Modified Project Summary/Abstract Section Cardiovascular disease (CVD) is the leading cause of death in the United States. Cardiac rehabilitation (CR) is an evidence-based, cost-effective, and widely available multidisciplinary program that combines supervised exercise with psychoeducation on health behavior change aimed at improving overall health and reducing cardiovascular risk in individuals with established CVD. However, some CVD patients (e.g., women, people from some racial and ethnic groups, low socioeconomic status, disabled) are less likely to maintain their adherence to key cardioprotective behaviors (weight management, physical activity [PA], and medication adherence) after CR and are less often involved in post-CR research; these factors combined increase the health differences in CVD care that these sub-populations experience, especially since many cannot complete self-pay Phase III maintenance programs. In the PI’s previous work, these patients indicated that they want technology-based maintenance support interventions that utilize technology they already own, are minimal burden, offer a flexible schedule, offer more support for patient needs without overwhelming them with program requirements before demonstrating that a lower level of support was insufficient, and produce desired results. Patients felt resistant to initiating a demanding, time- intensive, or in-person maintenance intervention immediately following CR. The present application utilizes a Sequential, Multiple Assignment, Randomized Trial (SMART) design to create a stepped care model that adapts to patient needs and minimizes patient burden. Participants (N=400) will be randomized to receive either a lowintensity text messaging intervention or an automated online program for 2 months and determine which produces superior adherence (Aim 1). Following classification as intervention responders or non- responders, responders will continue receiving their initial low-intensity intervention. We will then determine whether low- or high-intensity home-based CR (with or without case management) for 3 months produces better behavioral adherence following failure of a lowintensity intervention failure (Aim 2). We will then finalize the ideal adaptive intervention based on Aims 1 and 2 results and moderator analyses (Aim 3). Patients will complete post-intervention assessments at 6 months and exploratory outcomes assessment (death, rehospitalization, quality of life). This research will result in a stepped care model for under-resourced patients’ behavioral adherence maintenance following CR. This project advances the science of CVD treatment and post-CR care, and it will directly impact CVD patient outcomes by extending the benefits of evidence-based, effective care as well as target health differences among less-resourced CVD patients.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $659,472 )
2026	2026	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	3	7/16/2026	NON-COMPETING CONTINUATION	$659,472
														Subtotal = $659,472

Issue Date FY: 2025 ( Subtotal = $695,352 )
2025	2025	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	001	2	6/17/2025	NON-COMPETING CONTINUATION	$695,352
2025	2024	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	1	6/16/2025	NEW	$0
														Subtotal = $695,352

Issue Date FY: 2024 ( Subtotal = $740,798 )
2024	2024	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	1	8/6/2024	NEW	$740,798
														Subtotal = $740,798

Grand Total All Awards = $2,095,622

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An Application of SMART Methodology to Optimize an Intervention to Maintain Improvements in Health Behaviors in Under-resourced Patients after Phase II Cardiac Rehabilitation

Award Number: R01HL171158

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/15/2024

PERIOD OF PERFORMANCE END DATE: 04/30/2029

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