Project Overview

Our current NINR-funded RCT is testing the effectiveness of a 6-week intervention (Heart Up!) on increasing physical activity and decreasing hopelessness in adults with ischemic heart disease (IHD). Prior to the COVID-19 mitigation and containment efforts in March 2020, 43 participants were enrolled. Our RCT is collecting multiple key variables (hopelessness, depression, suicidal ideation, anxiety, perceived social support, Study enrollment motivation, QOL, well-being, and physical activity) at 3 time points over 6-months that may improve our understanding of how the RCT’s intervention may change the impact of the shelter-in-place/physical distancing measures on important mental, social, and behavioral health outcomes in a vulnerable population.

At the time of shelter-in-place/physical distancing, rather than pause the protocol, we modified the delivery of the in-person data collection and intervention components to remote (phone and video conferencing). We have since received IRB approval to resume enrollment of hospitalized patients either in-person or remotely, resulting in a COVID-19 compatible RCT. Enrollment resumed on May 29. Based on current information about the pandemic, adults with IHD are at higher risk for severe illness and death from COVID-19.

Given our high-risk population, remote intervention, key variables already being collected, longitudinal design, and timing of our study launch that provides us with comparative data prior and subsequent to COVID-19, we are in an excellent position to contribute new knowledge of important mental, social, and behavioral health characteristics of the pandemic that may be positively impacted by the RCT’s intervention.

Grant Number

3R01NR017649-04S1

Principal Investigator(s)

Research Aims

The purpose of this supplement is to determine whether and how the ongoing RCT intervention limits the negative impact of COVID-19 shelter-in-place/physical distancing measures on key mental, social, and behavioral health outcomes in IHD patients who report hopelessness.

We will evaluate how the three study arms (motivational social support [MSS] by a nurse with or without significant other support [SOS] or attention control [AC]) change the impact of COVID-19 shelter-in-place/physical distancing measures on health outcomes. This may lead to directly implementable, remote strategies (MSS with or without SOS) for health care professionals to promote self-management of important mental, social and behavioral health outcomes in an at-risk population (i.e. IHD) in this and future pandemics.

We will evaluate these impacts through a paired analysis comparing the 43 already enrolled patients to each other (pre- and during COVID-19) as well as comparing participants enrolled before COVID-19 shelter-in- place/physical distancing measures began to 43 patients enrolled after start of the pandemic. Because hopelessness can persist for up to 12 months in IHD patients, and it is unknown how long shelter-in-place/physical distancing measures and associated life changes might impact health outcomes in IHD patients, we will add two data collection time points (9 and 12 months) for all 86 participants, allowing us to evaluate long-term impact.

We will incorporate the Multi-Ethnic Study of Atherosclerosis COVID-19 Questionnaire to assess COVID-19 symptoms, diagnosis, testing, and social distancing at all time points.

The specific aims are:

Aim 1: Determine how the potentially negative impact of COVID-19 shelter-in-place/physical distancing measures on mental, social, and behavioral health outcomes are limited (moderated) by the RCT intervention.

  • H1: The intervention arms (MSS with or without SOS) will reduce or eliminate the negative effect of shelter-in-place/physical distancing measures on outcomes as compared to the AC arm. To evaluate, we will test for a statistical interaction between shelter-in-place/physical distancing measures and the three study arms in predicting future health outcomes, conducting a repeated measures analysis and pooling across waves.

Aim 2: Using the Coronavirus Impact Scale (quantifying how COVID-19 has changed the participant’s life via routine; income/employment; access to food, medical care, mental health care, extended family; and stress/discord), we will determine how the direct impact of COVID-19 life changes on mental, social, and behavioral health outcomes are limited (moderated) by the RCT intervention.

  • H2: Higher levels of COVID-19 life changes will be associated with poorer health outcomes in the AC arm of the study, but will have little to no association in the MSS with or without SOS arms. To evaluate, we will test for a significant interaction between COVID-19 life changes and RCT groups on health outcomes using a repeated measures analysis including all 86 participants.