Targeted Health Coaching to Improve Physical Activity Post-Structured Cardiac Rehabilitation (Target-CR)

Targeted Health Coaching Intervention to Improve Physical Activity Maintenance and Mobility Post-Structured Cardiac Rehabilitation Programming Among Older Adults: A Pilot Study

To identify factors and triggers influencing physical activity (PA) participation after structured cardiac rehabilitation (CR) among older adults who have enrolled in a center-based CR program, and compare the effects of a targeted health coaching intervention versus standard care immediately following structured CR on PA maintenance and functional fitness.

Study Overview

• Status: Active, not recruiting
• Conditions: Physical Activity; Cardiac Rehabilitation; Health Coaching
• Intervention / Treatment: Behavioral: Targeted Health Coaching Group; Behavioral: Standard Care Group

Detailed Description

Approximately 800,000 individuals in the United States have a heart attack every year, with almost 1 in 4 of those individuals already having suffered a previous heart attack. Attending cardiac rehabilitation (CR) following a cardiovascular event improves cardiorespiratory fitness and health-related quality of life, as well as decreases the risk of future illness and death from heart disease. Unfortunately, once an individual finishes a CR program, continued participation in physical activity (PA) too often reverts to previous sedentary patterns, limiting beneficial health effects. Continued participation in PA post-CR is especially challenging among older adults - likely due to a lack of self-efficacy and confidence in their ability to perform PA due to either their age or other health conditions that make PA more challenging. However, the need to address other health conditions, in conjunction with the benefits of improved strength and mobility, makes continued PA participation following a structured CR program even more useful for older adults. Although individuals typically understand habitual participation in PA is good for their health, we poorly understand why some individuals successfully adhere to and maintain PA habits, while others succumb to barriers preventing them from maintaining the health benefits beyond CR. In addition to understanding factors and triggers influencing PA maintenance beyond CR, little research has developed or investigated interventions targeting this important transition period following structured CR programming to promote continued PA participation "at home". Therefore, this proposal aims to 1) identify factors and triggers influencing PA participation after a traditional 36-session CR program (Stage 0); and 2) test a targeted health coaching intervention using these identified triggers to optimize PA maintenance and mobility among older adults who completed a center-based CR program.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine A. Collins, PhD; Phone Number: 919-479-2368; Email: katherine.collins791@duke.edu
• Study Contact Backup: Name: Johanna L. Johnson, MS; Phone Number: 919-660-6766; Email: johanna.johnson@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Center For Living

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Willingness to provide informed consent to participate in the Target-CR Study
• Must be able to read and speak English well enough to provide informed consent and understand instructions
• Age ≥60 years
• Diagnosed with coronary heart disease
• Of adequate clinical stability to allow study participation
• Own a smartphone device for application download

Exclusion Criteria:

• Planned relocation during the 3-month study period
• Medical procedure scheduled within the 3-month study period that may limit physical activity (i.e., joint replacement)
• Decompensated heart failure
• Heart failure - New York Heart Association class IV
• Severe pulmonary hypertension
• End-stage renal disease
• Cardiac transplantation
• Impairment from stroke, injury, or other medical condition that would prevent participation in the intervention
• Dementia that would prevent participation in the intervention and following study protocols
• Any other illnesses that, in the opinion of the local clinician, would negatively impact or mitigate participation in and completion of the protocol

• Psychiatric illness (self-report and screening)

  • Hospitalization for any psychiatric condition within one year (self-report)
  • Integrative Health Coaching Mental Health Screening Questionnaire score >4 (screening)
• Participation in an inpatient substance abuse rehabilitation program within one year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Targeted Health Coaching Group	Behavioral: Targeted Health Coaching Group; Participants in the THC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will partake in 6 virtual or in-person health coaching sessions lasting approximately 30-60 minutes in duration. These sessions will take place approximately every other week during the 3-month intervention period.
Placebo Comparator: Standard Care Group	Behavioral: Standard Care Group; Participants in the SC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will be provided with a single virtual or in-person education session, lasting approximately 30 minutes, at the beginning of the 3-month intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Activity Maintenance	Steps/day will be averaged across the intervention period	Baseline, 3 months
Percent Change in Physical Activity Maintenance	Calculated as (steps/day completed) divided by (steps/day prescribed) times 100 and average across the study period	Baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Senior Fitness Test Score (SFT)	Summed score from the six activities of the senior fitness test will be averaged. The six activities are: chair stand, arm curl, chair sit and reach, back scratch, 8-ft up and go, and 6-minute walk.	Baseline, 3 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: William E. Kraus, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Pro00112929; 1P30AG064201-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The proposed research is a Stage 0 and I pilot project that will involve a small sample (26 participants) in order to understand factors and triggers influencing physical activity participation immediately following a structured cardiac rehabilitation program and testing a targeted intervention approach to maintaining physical activity participation among older adults. Given the primary focus of this study will be intervention development and feasibility, we do not anticipate that sharing data will be of significant scientific or clinical merit. Therefore, we are not planning to share the data broadly. However, the structure of how we collect data, what data we collect, and how it will be monitored is part of the implementation and evaluation plan. Those materials will be made available.
• IPD Sharing Time Frame: No later than 1 year following completion of the funded project period.
• IPD Sharing Access Criteria: The project PI and Co-investigators who use the data will be made aware of the location of the data on the Duke University secure server. All other researchers will be asked to contact the project PI to discuss the secondary use of the data or the need for direct access beyond what will be made available on clinical trials.gov. All potential users will need to oblige to make no attempt to identify participants from de-identified data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No