Abstract
Objective:
Hopelessness is present in 27% of patients with ischaemic heart disease (IHD), can persist for 12 months and is associated with lack of physical activity (PA). No interventions have been tested to increase PA in IHD patients who report hopelessness. This study evaluated the feasibility of conducting a randomised controlled trial to investigate the effectiveness of the Heart Up! intervention, designed to reduce hopelessness through enhanced PA in IHD patients. It was hypothesised that increased PA would be identified in the intervention group.
Setting:
Patients were recruited from a large teaching hospital in the Midwestern USA. Data collection occurred in the patient’s home at 1 and 8 weeks after hospital discharge.
Methods:
A three-group design was used. Eligible patients were randomised to (1) motivational social support (MSS) from a nurse, (2) MSS from a nurse with social support from a significant other support (SOS) or (3) control. MSS-only and MSS-SOS recipients received motivational interviewing followed by 6 weeks of social support text messages from a nurse. MSS-SOS participants additionally received social support text messages from a significant other. Control participants received the usual care. Feasibility outcomes included recruitment and retention rates, patient acceptability and patient satisfaction. An accelerometer measured PA.
Results:
Of the 156 patients screened for the study, 43 met the inclusion criteria. Of eligible patients, 69.8% (n = 30) enrolled and 67% (n = 20) completed the study. Patients in the MSS and MSS-SOS groups expressed satisfaction with the intervention components (86% with motivational interviewing, 77% with nurse texts and 100% with significant other texts). Although differences were not statistically significant, a medium effect size for change in PA was identified in the MSS-SOS group compared to the other two groups.
Conclusion:
Study findings demonstrate the feasibility of the Heart Up! intervention and support testing its efficacy in a randomised controlled trial.
Introduction
Hopelessness has been reported to be present in 27% of patients with ischaemic heart disease (IHD) (Dunn et al., 2017; Kangelaris et al., 2010) and is associated with a 3 times increased risk of all-cause mortality or nonfatal myocardial infarction (MI; Pederson et al., 2007). Although hopelessness is related to depression, hopelessness is independently associated with the development and progression of IHD (Pederson et al., 2007). Whereas depression is the presence of depressed mood and/or a loss of interest/pleasure in activities, hopelessness is a negative outlook and sense of helplessness towards the future (Abramson et al., 1989). The future is challenging for patients with IHD as they are commonly faced with a new cardiac diagnosis, a number of recommended lifestyle changes, and an uncertain prognosis. Therefore, hopelessness may represent a state in response to these new events or may reflect a patient’s habitual outlook towards life (a trait) (Abramson et al., 1989). State hopelessness may be more responsive to short-term interventions that can be used in an outpatient setting, whereas trait hopelessness may require long-term cognitive therapy (Abramson et al., 1989). State hopelessness can persist for up to 12 months after hospital discharge (Dunn et al., 2017) and is associated with decreased physical functioning (Dunn et al., 2009) and decreased physical activity (PA) in home (Dunn et al., 2017) and hospital-based (Dunn et al., 2009) cardiac rehabilitation settings.
The evidence is overwhelming that physical inactivity independently contributes to increased risk of cardiovascular events and death (Ross et al., 2016; Win et al., 2011; Ye et al., 2013) and that PA reduces morbidity and mortality in patients with IHD (Anderson et al., 2016; Smith et al., 2011). Yet, a Cochrane review of 8 randomised controlled trials and 2 quasi-experimental studies originating from Canada, Germany, Japan, Switzerland, the UK and the USA (Davies et al., 2014), and an analysis of data from 3 US federal databases (Gaalema et al., 2014), indicate participation in hospital-based cardiac rehabilitation exercise programmes is poor(<20%). Adherence to home-based cardiac rehabilitation PA guidelines is also less than 50% (Dunn et al., 2017). Studies have investigated strategies to increase PA among general patients with IHD with some success (Anderson et al., 2016; Artinian et al., 2010; Dalal et al., 2010), while another study which focused on depressed IHD patients found limited improvement in PA levels (Freedland et al., 2009).
There have been no prior interventions tested to promote PA specifically in IHD patients who report hopelessness. A small number of studies examining the effect of PA on hopelessness in the general population demonstrate a beneficial effect of PA on decreasing hopelessness levels. A study with college students established that those who engaged in 20–30 minutes of aerobic activity at least 1 (males) to 3 (females) times per week demonstrated both significantly lower rates of hopelessness and a reduced relative risk of feeling hopeless compared with college students who did not engage in PA (Taliaferro et al., 2009). A cohort study of healthy men found that moderate to vigorous PA of ⩾2.5 hours per week and increased respiratory fitness predicted decreased hopelessness, independent of depression (Voltonen et al., 2009). The relationship between PA and hopelessness is important because hopeless individuals feel incapable of helping themselves (Abramson et al., 1989) and so may be at high risk for poor PA adherence. Interventions resulting in significant improvement in PA in other populations may not be effective in hopeless individuals, as individuals with hopelessness have a negative and helpless outlook on their health and future (Abramson et al., 1989). A significant gap exists in our knowledge of a cause and effect relationship between PA and hopelessness in IHD patients. Therefore, the feasibility testing of a randomised controlled trial in hopeless IHD patients is urgently needed.
Objective
The objective of this study was to evaluate the feasibility of conducting a randomised controlled trial investigating the effectiveness of an intervention called Heart Up!, designed to reduce hopelessness through enhanced PA in patients with IHD. Based on prior research with hopeless or depressed IHD patients (Carney et al., 1995; Davis et al., 2013), feasibility was defined as >50% of eligible hopeless patients enrolled and acceptability was defined as >50% of enrolled patients completing the study. Based on a randomised controlled trial examining adherence to depression self-care in patients with chronic illness (McCusker et al., 2016) and a report of 22 behavioural intervention studies (Dzewaltowski et al., 2004), feasibility was also defined as >90% of the intervention components being delivered. Because depression, a variable related to hopelessness, has been identified as a strong predictor of dissatisfaction with overall care in patients after a MI (Lee et al., 2008), satisfaction for this study was assumed if >75% of patients in the intervention groups had mean satisfaction scores of ⩾3.0 (on a 4-point Likert type scale) for each intervention component. It was hypothesised that we would find an increase in moderate to vigorous PA in the motivational social support (MSS) with significant other support (SOS) group, as compared to the MSS only and control groups.
Design
A three-group randomised controlled design was used to test the feasibility of the intervention in this pilot study.
Setting
Patients were recruited from three care units (progressive care, intermediate care, and telemetry) of a large teaching hospital in the Midwestern USA. The mean length of hospital stay for the sample was 3.26 days (standard deviation [SD] = 2.25). Data collection occurred in the patient’s home at 1 and 8 weeks after hospital discharge.
Methods
Patients were randomised to one of 3 groups: (1) MSS from a nurse, (2) MSS from a nurse with additional social support from a significant other (SOS), or (3) control. Patients were enrolled between April and December 2016. Inclusion criteria included mild to severe state hopelessness; 18 years of age or older; diagnosed with IHD, including MI or unstable angina, or having undergone percutaneous coronary intervention, stent, or coronary artery bypass graft surgery; able to use a cellphone and receive text messages; able to follow a PA programme in a home or cardiac rehabilitation setting; having a planned discharge home; ability to speak and read in English; and having the cognitive and physical ability to complete the screening instrument. There were no additional exclusion criteria. Data for all 3 groups were collected at home visits from a research assistant one week after hospital discharge and after completion of the 6 week intervention (or completion of 6 weeks of usual care for the control group). The human subject review boards of Michigan State University and Sparrow Health System approved the project. All patients provided written informed consent to participate and to be audio recorded.
Hopelessness screening and criteria
Patients were screened for hopelessness using the 6-item state subscale of the 14-item State-Trait Hopelessness Scale (STHS). The STHS was developed based on the Theory of Hopelessness Depression (Abramson et al., 1989). The STHS is measured on a 4-point Likert-type scale (1 = strongly disagree, 4 = strongly agree). Adding the item scores and dividing by the number of items provides a total mean score for each subscale, with a range of 1–4. Concurrent and predictive validity and reliability of the state (α > 0.87) subscale were previously established with 520 IHD patients (Dunn et al., 2014). Mild to severe state hopelessness was defined in this pilot as ⩾1.8, based on cut-points (1.8–2.0 = mild hopelessness and > 2.0 = moderate to severe hopelessness) that were associated with decreased PA in a previous study (Dunn et al., 2017).
Randomisation
Simple randomisation was used. Randomisation assignment was determined by sequentially numbered, opaque sealed envelopes (SNOSE). Randomisation resulted in approximately equal distribution of all variables across treatment groups (Table 1).
Patient characteristics 1 week after hospital discharge (N = 24).
MSS: motivational social support from nurse; SOS: social support from significant other; ANOVA: analysis of variance.
Chi-square test or ANOVA using simulation to estimate p-values due to small sample sizes.
Measures
Data collection for all three groups occurred in home visits from a research assistant that included accelerometer monitoring of PA. Demographic characteristics (age, sex, race, marital status, education level, and employment status) and clinical history (history of IHD and history of depression) were collected at baseline using a self-report questionnaire.
Feasibility and acceptability
For feasibility, data were collected on the number of patients screened for hopelessness, the number of patients eligible based on hopelessness scores and other inclusion criteria, the number who declined, the number enrolled and the number of interventions delivered. Acceptability was defined as the number of patients and significant others who completed the study and descriptions of those who did not.
Patient satisfaction
Patient satisfaction was measured upon completion of the 6-week intervention. A 30-item intervention satisfaction questionnaire was developed and used to assess satisfaction with each of the three components of the Heart Up! intervention: (1) motivational interviewing from the nurse, (2) text messaging from the nurse, and (3) text messaging from the significant other (10 items per component). Self-Determination Theory (SDT) (Deci and Ryan, 2008) was used as the framework for the development of the questionnaire. Questionnaire items are on a 4-point Likert-type scale (1 = strongly disagree, 4 = strongly agree). Adding the item scores and dividing by the number of items provides a total mean score for each component (range = 1 to 4). A mean score of ⩾3.0 was deemed indicative of satisfaction for each component. Four established nursing and communications researchers critiqued the questionnaire’s items for accuracy of content and clarity. Reliability for the components was adequate in this study: motivational interviewing (α = 0.94), text messaging by nurse (α = 0.93), and text messaging by significant other (α = 0.96).
Accelerometer
An Actigraph GT9X Link Accelerometer was used to measure PA. Patients wore the 3-axis accelerometer device on a strap around their waist for a 7-day period at both baseline and at the completion of the study. The device measures duration and intensity of acceleration and provides 13 cut-points for PA levels using counts per minute (ActiGraph LLC, 2018). For the purposes of this study, change in moderate (1,952–5,724 counts per minute) and vigorous (5,725–9,498 counts per minute) activity were examined.
The Heart Up! intervention
Theoretical development
The Heart Up! intervention, based on SDT (Ryan and Deci, 2017), includes motivational interviewing and text messaging components. Self-determined behaviour is likely to be associated with greater success in long-term behavioural change and maintenance (Deci and Ryan, 2008). Motivational interviewing, a directive, client-centred counselling style for eliciting behaviour change by helping clients explore and resolve ambivalence (Miller and Rollnick, 2013), has been effective in increasing PA in patients with IHD (Beckie and Beckstead, 2010; Janssen et al., 2013; Murphy et al., 2013); however, it has not been tested in individuals who report hopelessness. Motivational interviewing provides a supportive environment to enhance competence, autonomy, and relatedness, with the goal of allowing individuals to find a source of intrinsic motivation (Marklund et al., 2005).
The provision of additional social support within a person’s social network can further enhance a supportive environment (Cohen et al., 2001). Social support can include instrumental (material aid), informational (instruction) or emotional (encouragement, reassurance, caring) support (Cohen et al., 2001). For this study, researchers developed social support text messages based on Stress and Coping Social Support Theory (Cohen et al., 2001) and keeping with SDT, the messages provided emotional support within Cohen’s sub-category of encouragement. Examples of social support text messages include:
Use of mobile technology
The use of the existing technology of cellphones for social support was expected to provide an efficient and important enhancement to motivating hopeless patients to be physically active. There has been a continued increase in cellphone use worldwide, with a dramatic increase in cellphone use in many emerging countries (Pew Research Center, 2016). Despite the overall increase, richer countries continue to report higher levels of cellphone use than poorer nations (Pew Research Center, 2016). As of 2018, 95% of US adults owned a cellphone (100% of people age 18–29 years, 98% age 30–49 years, 94% age 50–64 years and 85% age 65 years and above) with slightly higher ownership rates among Blacks (98%) and Hispanics (97%), compared to Whites (94%) (Pew Research Center, 2018). Text messages from health professionals as reminders, information or for motivational purposes have been successful in increasing PA in patients with IHD (Burke et al., 2015; Chow et al., 2015); however, the efficacy of text messages has not been tested in hopeless individuals.
Motivational interviewing component
Patients in both the MSS and MSS with SOS groups participated in a 1-hour session with a motivational interviewer (nurse) in the patient’s home (week 1). The nurse used motivational interviewing techniques to explore the patient’s thoughts about making a behaviour change to attain adequate PA (Miller and Rollnick, 2013). Patients were encouraged to attain PA based on instructions provided by the hospital staff. Because of a hopeless patient’s negative and helpless outlook on the future, motivational interviewing sessions were tailored with emphasis on the benefits of PA and the patient’s confidence level in achieving PA. Patients completed two tools as part of the motivational interviewing: (1) an Importance of PA Ruler and (2) a Confidence with PA Ruler (each measured on a Likert-type scale).
Two nurses were randomly assigned to patients to deliver the motivational interviewing. The nurses completed online and in-person training from an experienced motivational interviewer and used a script for all sessions. Audio fidelity to the protocol was confirmed by the review of randomly selected recordings from 25% of the sessions. Audio reviews included the transcription and coding of the content by a trained research assistant, with each review being repeated by the principle investigator to confirm accuracy.
Text messaging component
Upon completion of the motivational interviewing, patients in both intervention groups received daily social support text messages (developed by the researchers) from the nurse 5 days per week for 6 weeks. Patients in the MSS with SOS group also received social support text messages (developed by the researchers) from their self-identified significant other during the same time period. The nurse texts were sent via an automated system. The nurse provided a hard copy of text messages to the patient’s significant other. The order of texts sent by the nurse and significant other were randomised so that they were unique to each patient. The automated system confirmed that each nurse text message was sent. During week 1, the nurse confirmed by phone with the patient that text messages had been received from the nurse and significant other. Patients and significant others kept logs to track the number of messages received, read or sent.
Enrolling and retaining patients with hopelessness
Because prior research with similar patients has identified low enrollment (6%) and completion (25%) rates (Davis et al., 2013), it was anticipated that patients who report hopelessness might be reluctant to enrol or complete the feasibility study. Therefore, strategies to improve enrollment and retention were developed and implemented. Patients meeting the hopelessness criteria were provided adequate time to discuss the study. When patients enrolled, they were scheduled for their first home visit and provided an appointment card prior to hospital discharge. Subsequent visits were scheduled in advance and reminder phone calls were made.
Analysis
Feasibility and acceptability
Frequencies and percentages were used to describe feasibility and acceptability. Feasibility was assumed if >50% of eligible hopeless patients enrolled in the study and if >90% of the study intervention components were delivered. Acceptability was supported if >50% of enrolled patients completed the study.
Satisfaction
Mean scores were used to examine patient satisfaction with the study intervention components. Satisfaction was assumed if >75% of patients in the intervention groups had mean satisfaction scores of ⩾3.0 for each intervention component.
Preliminary efficacy
Means were used to examine hopelessness and PA. Paired t-tests were used to test for changes in PA over time within treatment groups. Correlation tests were used to evaluate changes in PA and hopelessness. Chi-square tests and t-tests were used to evaluate potential differences in age, sex and race between patients who were eligible, enrolled or completed the study.
Results
Patient characteristics were typical of the IHD population (Table 1), although the sample was well-educated (58.3% with some college education) and racially homogeneous (87.5% being White). There were no significant differences in age, sex or race between patients who did versus did not meet the hopelessness criterion, were eligible versus not eligible for other reasons, enrolled versus did not enrol, or completed versus did not complete the study (Table 1).
Feasibility and acceptability
As seen in the CONSORT flow diagram (Figure 1) (Schulz et al., 2010), 156 patients were screened and 56 (35.9%) met the state hopelessness criterion. Of the 56 patients who reported hopelessness, 13 did not meet further eligibility criteria (9 did not have a cellphone or could not text, 4 could not perform PA). Of the remaining 43 patients, 30 (69.8%) enrolled in the study. Of the 30 enrolled, 24 completed baseline data (1 week after hospital discharge), and 20 (67%) completed the study. One patient died and 1 became ineligible due to a stroke. Other reasons given by patients for leaving the study included being too busy, being overwhelmed or family issues. There were no significant differences in age, sex or race between patients who did versus did not meet the hopelessness criterion, were eligible versus not eligible for other reasons, enrolled versus did not enrol or completed versus did not complete the study (detailed results not shown). All (100%) of the motivational interviewing sessions, 92.8% of text messages from the nurse (1 patient inadvertently gave a land line phone number) and 100% of texts from the significant other were delivered. All of the significant others completed their study component. All of the patients reported reading 100% of the texts received.

CONSORT flow diagram.
Satisfaction
Patients in the two MSS groups expressed satisfaction (mean > 3.0) with the intervention components, with 86% satisfied with the motivational interviewing, 77% with the social support text messages from the nurse, and 100% with the social support text messages from the significant other (Table 2). The two items specific to motivational interviewing that had the lowest mean satisfaction score were as follows: (1) ‘With the nurse, I was able to identify barriers that get in the way of my PA’ (86%) and (2) ‘After meeting with the nurse, I was more confident that I could be physically active’ (86%). Two items specific to text messages from the nurse that had the lowest scores were as follows: (1) ‘The text messages reminded me of my choices to get more PA’ (85%) and (2) ‘The text messages helped me to overcome barriers that can get in the way of my PA’ (77%).
Patient satisfaction with components of Heart Up! intervention a (range = 1–4).
Participants in both intervention groups received motivational interviewing and text messaging from a nurse, while only patients in the significant other group also received text messaging from a significant other.
Preliminary efficacy
Although not a focus of this feasibility study, the preliminary efficacy of the Heart Up! intervention was examined. Moderate to vigorous PA increased after the 6-week intervention for patients who received MSS with SOS (increase of 3.11 minutes/day, SD = 6.38, p = 0.25, n = 7), as compared to the MSS only (increase of 0.56 minutes/day, SD = 1.09, p = 0.22, n = 7) and control (decrease of 1.05 minutes/day, SD = 6.47, p = 0.74, n = 5) groups. Although the differences were not statistically significant, we found a medium effect size for change in PA for the MSS-SOS group versus both the MSS only group (d = 0.56) and the control group (d = 0.65). There was a small effect size for change in PA in the MSS only group versus the control group (d = 0.35). Although state hopelessness did not significantly decrease from baseline (mean = 2.27, SD = 0.38) to post-intervention (mean = 2.28, SD = 0.36) for the combined groups, a non-significant moderate negative relationship (r = −0.19, p = 0.45) was identified between change in cumulative minutes of moderate to vigorous PA and change in state hopelessness for the combined groups.
Discussion
Results of this study indicate feasibility of the Heart Up! intervention in a sample of IHD patients who reported hopelessness. The percentage of patients who reported hopelessness in this IHD sample was similar to that in prior research (Dunn et al., 2017). The percent of patients who reported hopelessness and who were willing to enrol in the study (69.8%) was higher than previous intervention research with hopeless IHD patients (6%) (Davis et al., 2013). This may be attributed to strategies used to increase recruitment and retention, as described earlier. The percent of patients who finished the study (67%) was also higher than in previous research with IHD patients who reported hopelessness (25%) (Davis et al., 2013). This finding may have been due to the reminder phone calls or the social support provided through the text messages. Adequate training of the research nurses likely contributed to the success of delivering the motivational interviewing. The automated system used for text messaging assured consistent delivery of messages by the nurse. The use of a hard copy list of text messages for the significant other’s use was also an effective strategy. There were no negative comments from significant others regarding the time needed for them to send the texts.
Implications for future study
Patients expressed satisfaction with each of the three components of the Heart Up! intervention (motivational interviewing, text messages from the nurse and text messages from the significant other), with a particularly high level of satisfaction with the social support text messages received from the patient’s significant other. Support from a significant other may be especially important to hopeless individuals, who feel incapable of helping themselves. Some patients indicated a lower level of satisfaction with the motivational interviewing and text messages received from the nurse specific to how the components assisted them in identifying barriers to PA. Patients who report hopelessness may be less able to identify and overcome barriers due to their negative and helpless outlook (Abramson et al., 1989). Although barriers to PA were addressed in the motivational interviewing session, the approach involved verbal discussion only. It may be more effective in a full randomised controlled trial to assist patients in writing out their potential barriers, with a follow-up discussion of strategies to overcome the barriers.
Some patients indicated lower satisfaction relative to motivational interviewing assisting them in enhancing their confidence to be physically active. Individuals who report hopelessness are at higher risk for low confidence (Abramson et al., 1989). Level of confidence was addressed as part of the motivational interviewing session by using a confidence ruler. It may be more effective in a full randomised controlled trial for the motivational interviewer to have a follow-up discussion about the patient’s confidence ruler responses and how the patient’s confidence level can be potentially improved.
Although several of the social support text messages from both the nurse and significant other were developed to encourage the patient to take progressively more steps or attain more minutes of PA per day, some patients indicated lower satisfaction regarding the text messages from the nurse reminding them of their PA choices. Choices for PA may be best addressed during the motivational interviewing session. A full randomised controlled trial should incorporate a review of the PA guidelines provided by the hospital staff, including types of PA and strategies for attaining more PA per day.
A medium effect size was identified in this pilot for improved PA in IHD patients who reported hopelessness and who were receiving MSS from a nurse with additional social support from a significant other. A fully powered randomised controlled trial is needed to more closely examine this effect. Data were collected at 1 and 8 weeks for this pilot feasibility study. We will collect data at 1, 8 and 24 weeks in our current large-scale trial in an effort to capture sustained changes in PA and hopelessness outcomes.
Limitations
Patients were enrolled at one hospital in the Midwestern USA and the sample lacked racial diversity, limiting generalisability. Examination of hopelessness in non-English speaking IHD patients from a variety of cultural backgrounds is needed. Sample sizes as small as 20 participants are acceptable in feasibility studies (Orsmond and Cohn, 2015); however, larger and more diverse samples will be needed in the future.
Conclusion
The Heart Up! intervention is the first of its kind aimed at promoting the physical and emotional health of a high-risk population of individuals with IHD who display hopelessness. Heart Up! incorporates widely available text messaging technology used in a new way (social support) in conjunction with motivational interviewing and the inclusion of the patient’s significant other. Motivational interviewing is a skill that can be done by a nurse during a home our outpatient visit. Following a motivational interviewing session with automated social support text messages translates into an efficient approach for providing motivation and support and inclusion of the patient’s significant other may increase the sustainability of the intervention. The Heart Up! intervention is practical and efficient with excellent potential for translation into practice. Study findings demonstrate the feasibility of the Heart Up! intervention and support testing the intervention’s efficacy in a full randomised controlled trial.
Footnotes
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Susan Dunn received funding for this work through the Michigan State University Trifecta Initiative and the Sparrow Health System/Michigan State University Centre for Innovation and Research.
