Rural HEART Camp Connect: A Feasibility Study

NCT05647759 | Completed

• 1 other identifier: 0773-20-FB
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study builds on the tested and refined HEART Camp intervention which has been shown to improve long-term adherence to exercise in individuals diagnosed with heart failure. HEART Camp Connect enhances HEART Camp by delivering the coaching via videoconference and providing access to hospital-based exercise facilities and online exercise programming. This study is a prospective, single-group, repeated measures feasibility study with 4 data collection points (baseline, 4, 8, and 12 weeks). Study variables including instruments will be collected at baseline, 4, and 8 weeks. Participants will also be asked to participate in a 30-45 minute interview at 12 weeks.

Conditions

Heart Failure

Keywords

cardiac rehabilitation; exercise adherence; virtual coaching

Outcome Measures

Primary Outcomes (2)

• Feasibility of administering Rural HEART Camp Connect

  Feasibility of administering an exercise intervention with the help of virtual exercise coaches to rural patients with heart failure including assessments of process, resources, and procedures as described below. Process Recruitment and retention monitoring, records of participant attendance at all sessions, monitor minutes coached for all HEART Camp participants Resources - staff availability, accessibility, staff training Procedures Identify connectivity issues, the number of potential participants without smart devices with optimal capacity for the HEART Camp Connect, and evaluating orientation to the Polar watch, rating of perceived exertion and digital diaries Data Management Ease of data collection including time to complete instruments, technological transfer of data, and patterns of missing data on an ongoing basis

  Baseline

• Determine perceptions of Rural HEART Camp connect in study participants

  Qualitative interviews will explore perceptions of all study procedures, including use of home-based exercise and virtual coaching.

  12 weeks

Study Arms (1)

HEART Camp Connect

EXPERIMENTAL

Participants will have access to a virtual exercise platform or membership to a medical exercise facility. Participants will meet with a virtual exercise coach via zoom on a weekly basis.

Behavioral: HEART Camp Connect

Interventions

HEART Camp Connect BEHAVIORAL

Once eligible and enrolled, participants will aim to complete 150 minutes of moderate-intensity exercise a week with the help of a virtual exercise coach

HEART Camp Connect

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of heart failure with preserved ejection fraction or heart failure (HF) with reduced ejection fraction (Stage C, chronic HF confirmed by echocardiography and clinical evaluation)
• years of age or older
• Stable pharmacologic therapy per guidelines for preceding 30 days
• Able to read and understand English.

You may not qualify if:

• Clinical evidence of decompensated heart failure
• Unstable angina
• Myocardial infarction, coronary artery bypass surgery, or biventricular pacemaker less than 6 weeks prior
• Orthopedic or neuromuscular disorders preventing participating in aerobic exercise
• Pregnancy
• Participation in 3 times per week aerobic exercise during the past 6 months
• Plans to move more than 50 miles from the exercise facility in the next 12 weeks
• Cardiopulmonary stress test results that preclude safe exercise training (arrhythmia) or cardiorespiratory fitness indicated by females with maximum oxygen consumption ≥ 21ml/kg/min and males with maximum oxygen consumption ≥ 24 ml/kg/min.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-5330, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Windy W Alonso, PhD, RN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: If consent is obtained in person, study personnel will be in a private room with both parties masked, eye protection, and social distancing guidelines in place. Baseline data collection will occur in a private room with masks, eye protection, and social distancing guidelines in place. Hospital-based facilities and staff are in compliance with local health department guidance on masks and social distancing.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a prospective, single-group, repeated measures feasibility study.

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: December 12, 2022
• Study Start: June 1, 2022
• Primary Completion: January 16, 2023
• Study Completion: September 5, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

US (1)