Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01NR017649 | U.S. NIH Grant/Contract | View source | |
| 3R01NR017649-04S1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
Not provided
Not provided
Not provided
Not provided
After a 30-year decline, heart disease is projected to increase up to 18% by 2030. Participation rates in cardiac rehabilitation remain extremely low and hopeless individuals are less likely to participate. This innovative study has the potential to advance science, improve patient care, and improve patient outcomes by demonstrating the effectiveness of the Heart Up! program to increase physical activity and reduce hopelessness in patients with heart disease. Hopelessness is associated with a 3.4 times increased risk of mortality or nonfatal myocardial infarction in patients with ischemic heart disease (IHD), independent of depression. Hopelessness has been identified in 27-52% of patients with IHD and can persist for up to 12 months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness toward the future, can be a temporary response to an event (state) or a habitual outlook (trait). Hopelessness is associated with decreased physical functioning and lower physical activity (PA) levels in individuals with IHD. While research has investigated strategies to increase PA among IHD patients in general, the study team is the only group to design an intervention to promote PA specifically in hopeless IHD patients. The purpose of this randomized controlled trial is to establish the effectiveness of our 6-week mHealth intervention (Heart Up!) to promote increased PA in hopeless patients with IHD. A total of 225 hopeless IHD patients will be enrolled from a large community teaching hospital in the Midwest. Patients will be randomized (75 per group) to one of three groups: 1) motivational social support (MSS) from a nurse, 2) MSS from a nurse with additional significant other support (SOS), or 3) attention control (AC). It is hypothesized that 1) The MSS with SOS group will have the greatest increase in average minutes of moderate to vigorous PA per day at 8 and 24 weeks as compared to the MSS only or AC groups; 2) Greater increase in minutes of moderate to vigorous PA per day will be associated with decreased state hopelessness levels from baseline to weeks 8 and 24; and 3) Increased social support and increased motivation will mediate the effects of Heart Up! on a greater increase in moderate to vigorous PA at 8 and 24 weeks. The findings from this study could transform care for IHD patients who are hopeless by promoting self-management of important PA goals that can contribute to better health outcomes.
Hopelessness is associated with a 3.4 times increased risk of mortality or nonfatal myocardial infarction in patients with ischemic heart disease (IHD), independent of depression. Hopelessness has been identified in 27-52% of patients with IHD and can persist for up to 12 months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness toward the future, can be a temporary response to an event (state) or a habitual outlook (trait). Hopelessness is associated with decreased physical functioning and lower physical activity (PA) levels in individuals with IHD. Low levels of PA independently contribute to increased death and adverse events in patients with IHD. Rates of PA in IHD patients continue to be unacceptably low in both hospital-based cardiac rehabilitation and home settings. Hopelessness frequently compounds this issue. The links among hopelessness, PA, and mortality and morbidity for patients with IHD remain unknown. While research has investigated strategies to increase PA among IHD patients in general, the study team is the only group to design an intervention to promote PA specifically in hopeless IHD patients. This research, based on Self Determination Theory and Cohen's Stress and Coping Social Support Theory, has shown feasibility and preliminary efficacy for a motivational intervention that integrates social support from both the patient's nurse and significant other to promote increased PA. The purpose of this randomized controlled trial is to establish the effectiveness of our 6-week mHealth intervention (Heart Up!) to promote increased PA in hopeless patients with IHD. The study team will enroll 225 hopeless IHD patients from a large community teaching hospital in the Midwest. Patients will be randomized (75 per group) to one of three groups: 1) motivational social support (MSS) from a nurse, 2) MSS from a nurse with additional significant other support (SOS), or 3) attention control (AC). Data will be collected at baseline, months 2, 6, 9 and 12 using an accelerometer for PA and valid and reliable instruments of physical and emotional health and behaviors. The specific aims are to: 1) test the effectiveness of 6 weeks of MSS and MSS with SOS on increasing mean minutes per day of moderate to vigorous PA, measured by an ActiGraph accelerometer; 2) determine the effects of change in minutes per day of moderate to vigorous PA on state hopelessness, measured by the State-Trait Hopelessness Scale; and 3): determine if social support (measured by the ENRICHD Social Support Inventory) and motivation (measured by the Exercise Self-Regulation Questionnaire) mediate the effects of the Heart Up! intervention on PA. The specific aims of the supplement are to: 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 and 2) using the Coronavirus Impact Scale, 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. The findings from this study could transform care for IHD patients who are hopeless by promoting self-management of important PA goals that can contribute to better health outcomes. This proposal supports NINR's investment in self-management to improve the quality of life for individuals with chronic illness.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational social support (MSS) from a nurse alone | Experimental | Participants will receive a 60-minute session of motivational interviewing via videoconference or telephone (at participant discretion) in their home from a trained nurse. The nurse will apply motivational interviewing techniques to explore the patient's thoughts about making a behavior change to attain adequate physical activity (PA). Patients will be encouraged to exercise based on instructions provided by the hospital staff. The patient's ability to take their radial pulse before and after PA will be assessed, and patients will be provided written instructions on the correct manner to take a radial pulse. Patients will receive daily motivational text messages from the nurse for 6 weeks. The texts will be sent via the REDCap automated system. The automated system confirms that texts were sent. The motivational interviewer nurse will confirm by phone that the patient receives her/his first text from the REDCap system. |
|
| MSS from nurse with additional significant other support (SOS) | Experimental | Participants will also receive a 60-minute session of motivational interviewing via videoconference or telephone (at participant discretion) in their home from a trained nurse and text messages from a nurse for 6 weeks, as described in arm 1. In addition, patients will receive daily text messages from their significant other for 6 weeks. Researchers developed the 42 significant other text messages. The motivational interviewing nurse will provide the text messages to the significant other in writing. The order of texts sent from the significant other will be randomized so that we can determine their effectiveness in general. The significant other will be asked to type and send the text message listed for each date to the patient. Study staff will confirm by phone that the patient received the first text from the significant other. Patients will be asked to track the number of text messages from the significant other that they read over the 6-week period using the log provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational social support from nurse | Behavioral | A 60-minute motivational interviewing session with a nurse, followed by 6 weeks of daily motivational social support text messages. |
| Measure | Description | Time Frame |
|---|---|---|
| Minutes/Day of Physical Activity (Measured by Actigraph) | Minutes/day of moderate to vigorous physical activity as measured by an ActiGraph GT9X Link Accelerometer. Higher number of minutes/day represents a better outcome, lower number of minutes/day represents a worse outcome. Characteristics were not collected for significant others in the SOS group. | Month 6 |
| State Hopelessness (Measured by State-Trait Hopelessness Scale) | Participant's report of current level of state hopelessness. Total score range= 1 (better) to 4 (worse). Characteristics were not collected for significant others in the SOS group. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Self-Regulation Questionnaire | Participant's report of exercise self-regulation level. Total score range= 1 (worse) to 7 (better). Characteristics were not collected for significant others in the SOS group. | Month 6 |
| ENRICHD Social Support Inventory |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• None
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan L Dunn, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32956255 | Background | Dunn SL, DeVon HA, Collins EG, Luong A, Buursma MP, Gutierrez-Kapheim M, Bronas UG. Suicide Risk Management Protocol for a Randomized Controlled Trial of Cardiac Patients Reporting Hopelessness. Nurs Res. 2021 Jan/Feb;70(1):72-79. doi: 10.1097/NNR.0000000000000474. | |
| 33428224 | Background | Dunn SL, Robbins LB, Tintle NL, Collins EG, Bronas UG, Goodyke MP, Luong A, Gutierrez-Kapheim M, DeVon HA. Heart up! RCT protocol to increase physical activity in cardiac patients who report hopelessness: Amended for the COVID-19 pandemic. Res Nurs Health. 2021 Apr;44(2):279-294. doi: 10.1002/nur.22106. Epub 2021 Jan 11. |
Not provided
Not provided
Researchers will adhere to the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. Data sets and associated documentation will be provided. The data sets will include data from questionnaires, the motivational intervention, and accelerometer-measured physical activity raw data elements and summary information. The dataset will be prepared in accordance with guidelines for the data repository. Key study documents (e.g., protocols, procedures, and instruments) that will enable the use of prepared data sets by outside investigators will be provided. A summary documentation file will be created to provide a complete overview of the data and a description of their use for investigators who are not familiar with the data set.
Summary results information from the clinical trial will be submitted to ClinicalTrials.gov no later than 12 months after the trial's completion date.
Data will only be made available under terms and conditions consistent with the informed consent provided by the individual participants, and as approved by the UIC IRB and any local, state, and federal laws and regulations. Requests can be made directly to the PI, who will review requests.
Not provided
Significant others were considered enrolled in the study only for the purposes of sending text messages to the MSS with SOS group participants. No data were collected from the significant others. Numbers provided for study enrollment, start, and completion represent the number of individual participants in the MI group, number of individual participants in the AC group, and the number of dyads in the MI with SOS group.
A total of 224 participants were enrolled while hospitalized for an IHD event in one large hospital in the Midwestern United States from August 2019 to November 2023. Participants were randomized to 1 of 3 groups: 1) Motivational social support (MSS) from a nurse, 2) MSS from a nurse with significant other support (SOS), and 3) attention control. Each SOS group participant identified a significant other who was asked to send the participant text messages.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Social Support (MSS) From a Nurse Alone (Individual Participants) | Participants received a 60-minute session of motivational interviewing via videoconference or telephone (at participant discretion) in their home from a trained nurse. The nurse applied motivational interviewing techniques to explore the patient's thoughts about making a behavior change to attain adequate physical activity (PA). Patients were encouraged to exercise based on instructions provided by the hospital staff. The patient's ability to take their radial pulse before and after PA was assessed, and patients were provided written instructions on the correct manner to take a radial pulse. Patients received daily motivational text messages from the nurse for 6 weeks. The texts were sent via the REDCap automated system. The automated system confirmed that texts were sent. The motivational interviewer nurse confirmed by phone that the patient received the first text from the REDCap system. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2018 |
Not provided
A three group RCT will be used to test the effectiveness of a mHealth intervention (Heart Up!) versus attention control to promote increased physical activity and reduce state hopelessness. Patients will be randomized to one of three groups: 1) motivational social support (MSS) from a nurse, 2) MSS from a nurse with additional significant other support (SOS), or 3) attention control (AC). Data will be collected at baseline, and 2, 6, 9 and 12 months.
Not provided
Not provided
The data collectors are also masked in the clinical trial.
| Attention control (AC) | Active Comparator | Participants in the AC group will receive a 60-minutes session with a nurse via videoconference or telephone (at participant discretion) viewing of American Heart Association educational videos and and documents regarding IHD. The nurse will additionally provide a written copy of the hospital physical activity instructions, will assess the patient's ability to take their pulse, and provide written instructions on the correct manner to take a radial pulse. |
|
| Motivational social support from nurse with additional support from significant other | Behavioral | A 60-minute motivational interviewing session with a nurse, followed by 6 weeks of daily motivational social support text messages from both a nurse and the patient's self-identified significant other. |
|
| Attention control | Behavioral | A 60-minute session with a nurse focused on American Heart Association educational videos and written information. |
|
Participant's report of perceived social support level. Total score range= 1 (worse) to 30 (better). Characteristics were not collected for significant others in the SOS group. |
| Month 6 |
| 33833190 | Background | Luong A, Goodyke M, Dunn SL, Baynard T, Bronas U. ActiGraph and Short-term Heart Rate Variability Study Protocol: Amended for the COVID-19 Pandemic. J Cardiovasc Nurs. 2021 Nov-Dec 01;36(6):599-608. doi: 10.1097/JCN.0000000000000817. |
| 39454079 | Derived | Goodyke MP, Tintle N, Collins E, DeVon HA, Bronas UG, Baynard T, Dunn SL. Lower Perceived Social Support Associated With Greater Hopelessness in Patients After an Acute Ischemic Heart Disease Event. J Cardiovasc Nurs. 2025 Sep-Oct 01;40(5):E239-E247. doi: 10.1097/JCN.0000000000001163. Epub 2024 Oct 24. |
| 38348815 | Derived | Goodyke MP, Bronas UG, Baynard T, Tintle N, DeVon HA, Collins E, Dunn SL. Relationships Among Heart Rate Variability, Perceived Social Support, and Hopelessness in Adults With Ischemic Heart Disease. J Am Heart Assoc. 2024 Feb 20;13(4):e032759. doi: 10.1161/JAHA.123.032759. Epub 2024 Feb 13. |
| FG001 | MSS From Nurse With Additional Significant Other Support (SOS) (Dyads) | Participants received a 60-minute session of motivational interviewing via videoconference or telephone (at participant discretion) in their home from a trained nurse and text messages from a nurse for 6 weeks, as described in arm 1. In addition, patients received daily text messages from their significant other for 6 weeks. Researchers developed the 42 significant other text messages. The motivational interviewing nurse provided the text messages to the significant other in writing. The order of texts sent from the significant other were randomized so that their effectiveness in general could be determined. The significant other was asked to type and send the text message listed for each date to the patient. Study staff confirmed by phone that the patient received the first text from the significant other. Patients were asked to track the number of text messages from the significant other that they read over the 6-week period. |
| FG002 | Attention Control (AC) (Individual Participants) | Participants in the AC group received a 60-minutes session with a nurse via videoconference or telephone (at participant discretion) that included viewing of American Heart Association educational videos and documents regarding IHD. The nurse additionally provided a written copy of the hospital physical activity instructions, assessed the patient's ability to take their pulse, and provided written instructions on the correct manner to take a radial pulse. |
| Completed baseline data collection |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Characteristics were not collected for significant others in the SOS group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Social Support (MSS) From a Nurse Alone (Individual Participants) | Participants received a 60-minute session of motivational interviewing via videoconference or telephone (at participant discretion) in their home from a trained nurse. The nurse applied motivational interviewing techniques to explore the patient's thoughts about making a behavior change to attain adequate physical activity (PA). Patients were encouraged to exercise based on instructions provided by the hospital staff. The patient's ability to take their radial pulse before and after PA was assessed, and patients were provided written instructions on the correct manner to take a radial pulse. Patients received daily motivational text messages from the nurse for 6 weeks. The texts were sent via the REDCap automated system. The automated system confirmed that texts were sent. The motivational interviewer nurse confirmed by phone that the patient received the first text from the REDCap system. |
| BG001 | MSS From Nurse With Additional Significant Other Support (SOS) (Dyads) | Participants received a 60-minute session of motivational interviewing via videoconference or telephone (at participant discretion) in their home from a trained nurse and text messages from a nurse for 6 weeks, as described in arm 1. In addition, patients received daily text messages from their significant other for 6 weeks. Researchers developed the 42 significant other text messages. The motivational interviewing nurse provided the text messages to the significant other in writing. The order of texts sent from the significant other were randomized so that their effectiveness in general could be determined. The significant other was asked to type and send the text message listed for each date to the patient. Study staff confirmed by phone that the patient received the first text from the significant other. Patients were asked to track the number of text messages from the significant other that they read over the 6-week period. |
| BG002 | Attention Control (AC) (Individual Participants) | Participants in the AC group received a 60-minutes session with a nurse via videoconference or telephone (at participant discretion) that included viewing of American Heart Association educational videos and documents regarding IHD. The nurse additionally provided a written copy of the hospital physical activity instructions, assessed the patient's ability to take their pulse, and provided written instructions on the correct manner to take a radial pulse. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Characteristics were not collected for significant others in the SOS group. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Characteristics were not collected for significant others in the SOS group. | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | Characteristics were not collected for significant others in the SOS group. | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | Characteristics were not collected for significant others in the SOS group. | Count of Participants | Participants |
| ||||||||||
| State Hopelessness Screening and Enrollment | The State-Trait Hopelessness Scale measures state hopelessness and trait hopelessness (state and trait hopelessness sub-scales are not combined); state hopelessness sub-scale range= 1 (strongly disagree, lower hopelessness) to 4 (strongly agree, higher hopelessness). Characteristics were not collected for significant others in the SOS group. | Mean | Standard Deviation | units on a scale |
| |||||||||
| State Hopelessness Baseline (2 Weeks: pre-intervention) | The 2-week state hopelessness data is relevant to the baseline time point in that the 2-week data wer collected after hospital discharge and prior to the initiation of the study intervention. There were fewer participants at 2 weeks due to attrition. The State-Trait Hopelessness Scale measures state hopelessness and trait hopelessness (state and trait hopelessness sub-scales are not combined); state hopelessness sub-scale range= 1 (strongly disagree, lower hopelessness) to 4 (strongly agree, higher hopelessness). Characteristics were not collected for significant others in the SOS group. | Of the 224 enrolled, 66 (29.5%) reconsidered study participation before baseline data collection. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Minutes/Day of Physical Activity (Measured by Actigraph) | Minutes/day of moderate to vigorous physical activity as measured by an ActiGraph GT9X Link Accelerometer. Higher number of minutes/day represents a better outcome, lower number of minutes/day represents a worse outcome. Characteristics were not collected for significant others in the SOS group. | Patient attrition, excessive lag time between baseline physical activity measurement and intervention start, and lack of physical activity measurement within 30 days of the 6-month time point resulted in a smaller than expected sample of participants with useable physical activity data. The overall number of participants analyzed reflects patients only (data was not collected from significant others in the SOS group). | Posted | Mean | Standard Deviation | minutes/day | Month 6 |
|
|
| |||||||||||||||||||||||||||||||
| Primary | State Hopelessness (Measured by State-Trait Hopelessness Scale) | Participant's report of current level of state hopelessness. Total score range= 1 (better) to 4 (worse). Characteristics were not collected for significant others in the SOS group. | Patient attrition, excessive lag time between baseline state hopelessness measurement and intervention start, and lack of state hopelessness measurement within 30 days of the 6-month time point resulted in a smaller than expected sample of participants with useable hopelessness data. The overall number of participants analyzed reflects patients only (data was not collected from significant others in the SOS group). | Posted | Mean | Standard Deviation | units on a scale | Month 6 |
| |||||||||||||||||||||||||||||||||
| Secondary | Exercise Self-Regulation Questionnaire | Participant's report of exercise self-regulation level. Total score range= 1 (worse) to 7 (better). Characteristics were not collected for significant others in the SOS group. | Patient attrition, excessive lag time between baseline exercise self regulation measurement and intervention start, and exercise self regulation measurement within 30 days of the 6-month time point resulted in a smaller than expected sample of participants with useable data. The overall number of participants analyzed reflects patients only (data was not collected from significant others in the SOS group). | Posted | Mean | Standard Deviation | units on a scale | Month 6 |
| |||||||||||||||||||||||||||||||||
| Secondary | ENRICHD Social Support Inventory | Participant's report of perceived social support level. Total score range= 1 (worse) to 30 (better). Characteristics were not collected for significant others in the SOS group. | Patient attrition, excessive lag time between baseline perceived social support measurement and intervention start, and perceived social support measurement within 30 days of the 6-month time point resulted in a smaller than expected sample of participants with useable data. The overall number of participants analyzed reflects patients only (data was not collected from significant others in the SOS group). | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
|
Adverse event data were collected from individual patient participants from enrollment to 6 months. Data (including adverse event data) were not collected from significant others in SOS group whose role was limited to sending text messages from their phone for a 6-week period as part of the intervention.
Serious adverse events (SAEs) include moderate and high suicide ideation, coronary artery re-occlusion, study-related hospitalization or change in health condition, and death of a participant. Data (including adverse event data) were not collected from significant others in SOS group whose role was limited to sending text messages from their phone for a 6-week period as part of the intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motivational Social Support (MSS) From a Nurse Alone (Individual Participants) | Participants received a 60-minute session of motivational interviewing via videoconference or telephone (at participant discretion) in their home from a trained nurse. The nurse applied motivational interviewing techniques to explore the patient's thoughts about making a behavior change to attain adequate physical activity (PA). Patients were encouraged to exercise based on instructions provided by the hospital staff. The patient's ability to take their radial pulse before and after PA was assessed, and patients were provided written instructions on the correct manner to take a radial pulse. Patients received daily motivational text messages from the nurse for 6 weeks. The texts were sent via the REDCap automated system. The automated system confirmed that texts were sent. The motivational interviewer nurse confirmed by phone that the patient received the first text from the REDCap system. | 1 | 75 | 5 | 75 | 25 | 75 |
| EG001 | MSS From Nurse With Additional Significant Other Support (SOS) (Dyads) | Participants received a 60-minute session of motivational interviewing via videoconference or telephone (at participant discretion) in their home from a trained nurse and text messages from a nurse for 6 weeks, as described in arm 1. In addition, patients received daily text messages from their significant other for 6 weeks. Researchers developed the 42 significant other text messages. The motivational interviewing nurse provided the text messages to the significant other in writing. The order of texts sent from the significant other were randomized so that their effectiveness in general could be determined. The significant other was asked to type and send the text message listed for each date to the patient. Study staff confirmed by phone that the patient received the first text from the significant other. Patients were asked to track the number of text messages from the significant other that they read over the 6-week period. Adverse events were not collected for significant others in the SOS group. | 0 | 75 | 7 | 75 | 27 | 75 |
| EG002 | Attention Control (AC) (Individual Participants) | Participants in the AC group received a 60-minutes session with a nurse via videoconference or telephone (at participant discretion) that included viewing of American Heart Association educational videos and documents regarding IHD. The nurse additionally provided a written copy of the hospital physical activity instructions, assessed the patient's ability to take their pulse, and provided written instructions on the correct manner to take a radial pulse. | 0 | 74 | 2 | 74 | 23 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation moderate | General disorders | Systematic Assessment |
| ||
| Suicidal ideation high | General disorders | Systematic Assessment |
| ||
| Coronary reocclusion | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation low | General disorders | Systematic Assessment |
| ||
| Hospitalization all cause | General disorders | Systematic Assessment |
| ||
| Change in health all cause | General disorders | Systematic Assessment |
|
Of the 224 patient participants enrolled during hospitalization, 66 (29.5%) reconsidered study participation prior to the post-hospital discharge data collection time point (2 weeks). Future research focused on this population should consider expanding the recruitment timeline to reduce attrition between enrollment and first data collection visit.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Dunn, Professor Emeritus | University of Illinois Chicago | (312) 996-7800 | sdunn01@uic.edu |
| Dec 27, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D009043 | Motor Activity |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001519 | Behavior |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
|
|
|
|
|
|
| OG001 | MSS From Nurse With Additional Significant Other Support (SOS) | Motivational social support from nurse with additional support from significant other: A 60-minute motivational interviewing session with a nurse, followed by 6 weeks of daily motivational social support text messages from both a nurse and the patient's self-identified significant other. |
| OG002 | Attention Control (AC) | Participants in the AC group will receive a 60-minutes session with a nurse via videoconference or telephone (at participant discretion) viewing of American Heart Association educational videos and and documents regarding IHD. The nurse will additionally provide a written copy of the hospital physical activity instructions, will assess the patient's ability to take their pulse, and provide written instructions on the correct manner to take a radial pulse. |
|
|
| OG001 | MSS From Nurse With Additional Significant Other Support (SOS) | Motivational social support from nurse with additional support from significant other: A 60-minute motivational interviewing session with a nurse, followed by 6 weeks of daily motivational social support text messages from both a nurse and the patient's self-identified significant other. |
| OG002 | Attention Control (AC) | Participants in the AC group will receive a 60-minutes session with a nurse via videoconference or telephone (at participant discretion) viewing of American Heart Association educational videos and and documents regarding IHD. The nurse will additionally provide a written copy of the hospital physical activity instructions, will assess the patient's ability to take their pulse, and provide written instructions on the correct manner to take a radial pulse. |
|
|
| OG001 | MSS From Nurse With Additional Significant Other Support (SOS) | Motivational social support from nurse with additional support from significant other: A 60-minute motivational interviewing session with a nurse, followed by 6 weeks of daily motivational social support text messages from both a nurse and the patient's self-identified significant other. |
| OG002 | Attention Control (AC) | Participants in the AC group will receive a 60-minutes session with a nurse via videoconference or telephone (at participant discretion) viewing of American Heart Association educational videos and and documents regarding IHD. The nurse will additionally provide a written copy of the hospital physical activity instructions, will assess the patient's ability to take their pulse, and provide written instructions on the correct manner to take a radial pulse. |
|
|