Trial Outcomes & Findings for Reducing Hopelessness Through Improved Physical Activity in Adults With Heart Disease: With COVID-19 Considerations (NCT NCT03907891)
NCT ID: NCT03907891
Last Updated: 2026-02-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
224 participants
Primary outcome timeframe
Month 6
Results posted on
2026-02-13
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
74
|
|
Overall Study
Completed baseline data collection
|
56
|
49
|
53
|
|
Overall Study
COMPLETED
|
46
|
38
|
47
|
|
Overall Study
NOT COMPLETED
|
29
|
37
|
27
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
20
|
27
|
23
|
|
Overall Study
Lost to Follow-up
|
8
|
5
|
4
|
|
Overall Study
Patient could no longer identify significant other
|
0
|
3
|
0
|
|
Overall Study
Decline in health
|
0
|
2
|
0
|
Baseline Characteristics
Of the 224 enrolled, 66 (29.5%) reconsidered study participation before baseline data collection.
Baseline characteristics by cohort
| Measure |
Motivational Social Support (MSS) From a Nurse Alone (Individual Participants)
n=75 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.
|
MSS From Nurse With Additional Significant Other Support (SOS) (Dyads)
n=75 Participants
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.
|
Attention Control (AC) (Individual Participants)
n=74 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.
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 10.1 • n=75 Participants
|
62.0 years
STANDARD_DEVIATION 9.4 • n=75 Participants
|
63.4 years
STANDARD_DEVIATION 9.9 • n=74 Participants
|
62.6 years
STANDARD_DEVIATION 10.0 • n=224 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=75 Participants
|
23 Participants
n=75 Participants
|
20 Participants
n=74 Participants
|
68 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=75 Participants
|
52 Participants
n=75 Participants
|
54 Participants
n=74 Participants
|
156 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=75 Participants
|
5 Participants
n=75 Participants
|
2 Participants
n=74 Participants
|
7 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=75 Participants
|
70 Participants
n=75 Participants
|
72 Participants
n=74 Participants
|
217 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=75 Participants
|
0 Participants
n=75 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=75 Participants
|
0 Participants
n=75 Participants
|
3 Participants
n=74 Participants
|
5 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=75 Participants
|
0 Participants
n=75 Participants
|
1 Participants
n=74 Participants
|
2 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=75 Participants
|
0 Participants
n=75 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=75 Participants
|
3 Participants
n=75 Participants
|
1 Participants
n=74 Participants
|
8 Participants
n=224 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=75 Participants
|
68 Participants
n=75 Participants
|
67 Participants
n=74 Participants
|
202 Participants
n=224 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=75 Participants
|
4 Participants
n=75 Participants
|
2 Participants
n=74 Participants
|
7 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=75 Participants
|
0 Participants
n=75 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=224 Participants
|
|
State Hopelessness Screening and Enrollment
|
2.076 units on a scale
STANDARD_DEVIATION 0.292 • n=75 Participants
|
2.119 units on a scale
STANDARD_DEVIATION 0.253 • n=75 Participants
|
2.024 units on a scale
STANDARD_DEVIATION 0.211 • n=74 Participants
|
2.07 units on a scale
STANDARD_DEVIATION 0.26 • n=224 Participants
|
|
State Hopelessness Baseline (2 Weeks: pre-intervention)
|
1.791 units on a scale
STANDARD_DEVIATION 0.464 • n=56 Participants • Of the 224 enrolled, 66 (29.5%) reconsidered study participation before baseline data collection.
|
1.818 units on a scale
STANDARD_DEVIATION 0.508 • n=49 Participants • Of the 224 enrolled, 66 (29.5%) reconsidered study participation before baseline data collection.
|
1.813 units on a scale
STANDARD_DEVIATION 0.372 • n=53 Participants • Of the 224 enrolled, 66 (29.5%) reconsidered study participation before baseline data collection.
|
1.813 units on a scale
STANDARD_DEVIATION 0.45 • n=158 Participants • Of the 224 enrolled, 66 (29.5%) reconsidered study participation before baseline data collection.
|
PRIMARY outcome
Timeframe: Month 6Population: 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).
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.
Outcome measures
| Measure |
MSS From Nurse With Additional Significant Other Support (SOS)
n=21 Participants
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.
|
Attention Control (AC)
n=28 Participants
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 (MSS) From a Nurse Alone (Individual Participants)
n=28 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.
|
|---|---|---|---|
|
Minutes/Day of Physical Activity (Measured by Actigraph)
|
4.8 minutes/day
Standard Deviation 5.4
|
8.6 minutes/day
Standard Deviation 12.0
|
6.7 minutes/day
Standard Deviation 8.1
|
PRIMARY outcome
Timeframe: Month 6Population: 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).
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.
Outcome measures
| Measure |
MSS From Nurse With Additional Significant Other Support (SOS)
n=21 Participants
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.
|
Attention Control (AC)
n=28 Participants
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 (MSS) From a Nurse Alone (Individual Participants)
n=28 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.
|
|---|---|---|---|
|
State Hopelessness (Measured by State-Trait Hopelessness Scale)
|
1.72 units on a scale
Standard Deviation 0.52
|
1.74 units on a scale
Standard Deviation 0.42
|
1.68 units on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Month 6Population: 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).
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.
Outcome measures
| Measure |
MSS From Nurse With Additional Significant Other Support (SOS)
n=21 Participants
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.
|
Attention Control (AC)
n=28 Participants
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 (MSS) From a Nurse Alone (Individual Participants)
n=28 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.
|
|---|---|---|---|
|
Exercise Self-Regulation Questionnaire
|
4.82 units on a scale
Standard Deviation 1.05
|
4.86 units on a scale
Standard Deviation 1.28
|
4.45 units on a scale
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Month 6Population: 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).
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.
Outcome measures
| Measure |
MSS From Nurse With Additional Significant Other Support (SOS)
n=21 Participants
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.
|
Attention Control (AC)
n=28 Participants
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 (MSS) From a Nurse Alone (Individual Participants)
n=28 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.
|
|---|---|---|---|
|
ENRICHD Social Support Inventory
|
22.86 score on a scale
Standard Deviation 4.48
|
22.64 score on a scale
Standard Deviation 2.82
|
22.11 score on a scale
Standard Deviation 3.18
|
Adverse Events
Motivational Social Support (MSS) From a Nurse Alone (Individual Participants)
Serious events: 5 serious events
Other events: 25 other events
Deaths: 1 deaths
MSS From Nurse With Additional Significant Other Support (SOS) (Dyads)
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Attention Control (AC) (Individual Participants)
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Motivational Social Support (MSS) From a Nurse Alone (Individual Participants)
n=75 participants at risk
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.
|
MSS From Nurse With Additional Significant Other Support (SOS) (Dyads)
n=75 participants at risk
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.
|
Attention Control (AC) (Individual Participants)
n=74 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Suicidal ideation moderate
|
1.3%
1/75 • Number of events 1 • 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.
|
4.0%
3/75 • Number of events 3 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
General disorders
Suicidal ideation high
|
0.00%
0/75 • 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.
|
1.3%
1/75 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Cardiac disorders
Coronary reocclusion
|
5.3%
4/75 • Number of events 4 • 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.
|
4.0%
3/75 • Number of events 3 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Motivational Social Support (MSS) From a Nurse Alone (Individual Participants)
n=75 participants at risk
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.
|
MSS From Nurse With Additional Significant Other Support (SOS) (Dyads)
n=75 participants at risk
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.
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Attention Control (AC) (Individual Participants)
n=74 participants at risk
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.
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|---|---|---|---|
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General disorders
Suicidal ideation low
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6.7%
5/75 • Number of events 15 • 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.
|
8.0%
6/75 • Number of events 19 • 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.
|
5.4%
4/74 • Number of events 16 • 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.
|
|
General disorders
Hospitalization all cause
|
12.0%
9/75 • Number of events 24 • 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.
|
14.7%
11/75 • Number of events 27 • 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.
|
16.2%
12/74 • Number of events 30 • 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.
|
|
General disorders
Change in health all cause
|
33.3%
25/75 • Number of events 44 • 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.
|
30.7%
23/75 • Number of events 50 • 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.
|
28.4%
21/74 • Number of events 47 • 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.
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Additional Information
Dr. Susan Dunn, Professor Emeritus
University of Illinois Chicago
Phone: (312) 996-7800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place