Trial Outcomes & Findings for The Healthy Heart Study (NCT NCT02105246)

NCT ID: NCT02105246

Last Updated: 2019-04-01

Results Overview

Number of eligible patients who participated in at least one cardiac rehabilitation exercise session.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1154 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2019-04-01

Participant Flow

Participant milestones

Measure	Referral to Home-based Cardiac Rehabilitation Referral to home-based cardiac rehabilitation (intervention): Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes.	Referral to Center-based Cardiac Rehabilitation Referral to center-based cardiac rehabilitation (standard of care): Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting.
Overall Study STARTED	557	597
Overall Study COMPLETED	557	597
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Healthy Heart Study

Baseline characteristics by cohort

Measure	Home-based n=557 Participants Referral to home-based cardiac rehabilitation (intervention): Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes.	Center-based n=597 Participants Referral to center-based cardiac rehabilitation (standard of care): Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting.	Total n=1154 Participants Total of all reporting groups
Age, Continuous	67 years STANDARD_DEVIATION 9 • n=5 Participants	66 years STANDARD_DEVIATION 10 • n=7 Participants	66.5 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	550 Participants n=5 Participants	587 Participants n=7 Participants	1137 Participants n=5 Participants
Race/Ethnicity, Customized White non-Hispanic	378 Participants n=5 Participants	420 Participants n=7 Participants	798 Participants n=5 Participants
Race/Ethnicity, Customized Black	41 Participants n=5 Participants	40 Participants n=7 Participants	81 Participants n=5 Participants
Race/Ethnicity, Customized Asian	16 Participants n=5 Participants	3 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	51 Participants n=5 Participants	4 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized Missing data	71 Participants n=5 Participants	130 Participants n=7 Participants	201 Participants n=5 Participants
Region of Enrollment United States	557 participants n=5 Participants	597 participants n=7 Participants	1154 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Number of eligible patients who participated in at least one cardiac rehabilitation exercise session.

Outcome measures

Measure	Referral to Home-based Cardiac Rehabilitation n=557 Participants Referral to a home-based cardiac rehabilitation program (intervention). Referral to home-based cardiac rehabilitation: Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes.	Referral to Center-based Cardiac Rehabilitation n=597 Participants Referral to a center-based cardiac rehabilitation program (standard of care). Referral to center-based cardiac rehabilitation: Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting.
Participation in Cardiac Rehabilitation	231 Participants	252 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: This analysis compared 3-month change in 6-minute walk test distance among subjects who participated in home-based vs. center-based cardiac rehab. Data from participants who completed the 3 month follow up visit are presented.

Baseline to 3-month change in 6-minute walk test distance (feet) among subjects who participated in home-based vs. center-based cardiac rehab.

Outcome measures

Measure	Referral to Home-based Cardiac Rehabilitation n=86 Participants Referral to a home-based cardiac rehabilitation program (intervention). Referral to home-based cardiac rehabilitation: Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes.	Referral to Center-based Cardiac Rehabilitation n=93 Participants Referral to a center-based cardiac rehabilitation program (standard of care). Referral to center-based cardiac rehabilitation: Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting.
Change in Distance Completed on 6-minute Walk Test	324 feet Interval 160.0 to 544.0	128 feet Interval 20.0 to 226.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: This analysis compares 6-month change in 6-minute walk test distance (feet) among patients who participated in home-based cardiac rehab vs. patients who participated in center-based cardiac rehab.

Baseline to 6-month change in 6-minute walk test distance (feet) among patients who participated in home-based vs. center-based cardiac rehab.

Outcome measures

Measure	Referral to Home-based Cardiac Rehabilitation n=33 Participants Referral to a home-based cardiac rehabilitation program (intervention). Referral to home-based cardiac rehabilitation: Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes.	Referral to Center-based Cardiac Rehabilitation n=70 Participants Referral to a center-based cardiac rehabilitation program (standard of care). Referral to center-based cardiac rehabilitation: Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting.
Change in Distance Completed on 6-minute Walk Test	315 feet Interval 60.0 to 544.0	156 feet Interval 56.0 to 305.0

Adverse Events

Referral to Home-based Cardiac Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Referral to Center-based Cardiac Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mary Whooley

San Francisco VA Healthcare System

Phone: 415-221-4810

Email: mary.whooley@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place