HeartHome: A Nurse-Driven, Home-Based Cardiac Rehabilitation Program

NCT04131816 | Completed

• 1 other identifier: 18-2540
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this implementation trial is to execute a nurse-led, home-based cardiac rehabilitation (HBCR) program, evaluate the program's impact on patient outcomes over 6 months; and compare outcomes of HeartHome (HH) participants to a group of participants in traditional cardiac rehabilitation (CR).

Conditions

Myocardial Infarction; Acute Coronary Syndrome; ST-segment Elevation Myocardial Infarction (STEMI); Non-ST-Segment Elevation Myocardial Infarction (NSTEMI); Angina, Stable

Keywords

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (8)

• Number of HeartHome patient referrals into the HeartHome program

  Number of patient referrals into the HeartHome program will be measured by the total number of participants eligible to enroll in traditional cardiac rehab that were referred to the HeartHome program.

  10 months after beginning of study

• Proportion of HeartHome patient referral into the HeartHome program

  Proportion of patient referrals into the HeartHome program will be measured by the number of patients referred to the HeartHome program relative to the number of patients referred to traditional cardiac rehab.

  10 months after beginning of study

• Proportion of HeartHome patient enrollments in the HeartHome program

  Proportion of patient enrollments in the HeartHome program will be measured by the number of patients who enroll in the HeartHome program relative to the number of eligible patients referred to the HeartHome program. Enrollment is defined by signing the study consent form.

  10 months after beginning of study

• Participation in HeartHome's participants in-person visits

  Participation in HeartHome's in-person visits will be measured by the number of in-person visits that each participant attends relative to the total number of in-person visits. The total number of visits possible per person is 5, with higher numbers associated with better participation.

  12 weeks post HeartHome intervention start

• Participation in HeartHome's participants interactive online classes

  Participation in HeartHome's online classes will be measured by the number of online classes that each participant attends relative to the total number of interactive online classes. The total number of classes possible is 7, with higher numbers associated with better participation.

  12 weeks post HeartHome intervention start

• Participation in HeartHome intervention calls

  Participation in HeartHome's calls will be measured by the number of calls that each participant attends relative to the total number of calls. The total number of calls possible is 8, with higher rate associated with better participation.

  12 weeks post HeartHome intervention start

• HeartHome intervention weekly goal adherence score

  Adherence to weekly goals will be measured by participant goal achievement, which includes 33 opportunities for goal achievement and progression. The range is 0-33, with higher scores associated with greater adherence to weekly goals.

  12 weeks post HeartHome intervention start

• Number of sessions completed.

  Sessions completed by participants will be measured by the total number of calls, interactive online classes, and in-person visits attended. The total number of sessions is 20, with higher numbers associated with higher participation. Sessions completed by the control group will be measured by the total number of exercise sessions and classes attended. The total number of sessions for the control group is 46, with higher numbers associated with higher participation.

  13-weeks post start of HeartHome and control intervention

Secondary Outcomes (33)

• HeartHome participants' physical function at baseline and at week 12

  12 weeks post start of HeartHome intervention

• Change in HeartHome participant's physical functioning, sub score of RAND SF-36 from baseline to week 12 and baseline to week 24.

  12- and 24-weeks post start of intervention

• Change in HeartHome participant's role limitations due to physical health, sub score of RAND SF-36 from baseline to week 12 and baseline to week 24.

  12- and 24- weeks post start of intervention

• Change in HeartHome participant's role limitations due to emotional problems, sub score of RAND SF-36 from baseline to week 12 and baseline to week 24.

  12- and 24- weeks post start of intervention

• Change in HeartHome participant's energy/fatigue, sub score of RAND SF-36 from baseline to week 12 and baseline to week 24.

  12- and 24- weeks post start of intervention

Study Arms (2)

HeartHome Intervention

EXPERIMENTAL

Participants will be in the HeartHome program for a total of 12 weeks.

Behavioral: HeartHome

Control

NO INTERVENTION

De-identified data from 150 patients who attend a traditional cardiac rehabilitation program during the same general time of the HeartHome implementation

Interventions

HeartHome BEHAVIORAL

The HeartHome program is an expanded home-based cardiac rehabilitation program that combines nurse home visits with telephone and electronic supports for participants that allows them to engage in cardiac rehabilitation activities at home.

HeartHome Intervention

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with one of the following conditions: myocardial infarction (MI)/acute coronary syndrome (ACS), ST-elevation myocardial infarction (STEMI), non-STEMI, percutaneous coronary intervention (PCI) or stable angina;
• Decline traditional cardiac rehab or do not respond to traditional cardiac rehab enrollment methods;
• Willing to have a nurse visit them in their home and receive follow-up phone calls and text messages for a 12-week intervention period;
• Understand the requirements of participation in and consent to the HeartHome program;
• Live within a 75-mile radius of the study site.

You may not qualify if:

• Diagnosis of heart failure
• Diagnosis of valvular heart disease
• Presence of cardiac disease requiring surgery or other invasive procedure
• Impaired mental capacity resulting in an inability to understand or follow directions and study protocol
• Impaired functional abilities that prevent them from participating in physical activity
• Presence of any serious medical conditions that are likely to cause premature death or to impair functional capacity
• No access to a telephone

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Health Care

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Angina, Stable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Cheryl Jones, PhD, RN

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: November 10, 2019
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)