Feasibility, Acceptability, and Intervention Description of a Mobile Health Intervention in Patients With Heart Failure.

Mobile health (mHealth) is used to encourage and support self-management skills in patients with heart failure. The purpose of the study was to describe the feasibility, fidelity, usability, and acceptability of mHealth interventions. This pilot study used a randomized 3-group (enhanced usual care, mHealth, and mHealth plus, which included a nurse practitioner and community health worker) repeated-measure design to determine the feasibility of using a self-management behavior app and a Bluetooth-enabled scale for daily self-monitoring of weights and medications. In the 2 mHealth groups, of the 48 patients, 38 (79%) engaged partially in recording daily weights and medications, and of the 74 patients in the sample, we obtained partial to complete data on 63 (85%) of the patients during follow-up outcome phone calls. Most patients found the intervention to be feasible, usable, and acceptable, and (93%) patients in the mHealth group and 100% of patients in the mHealth plus group agreed or strongly agreed that they learned how to self-manage their heart failure using the app. The intervention was reasonable to implement and provided insight for future intervention improvements.

"Ask, 'When You Do This, How Much Pain Are You In?'": Content Preferences for a Conversational Pain Self-Management Software Application.

The purpose of the current study was to examine older adults' preferences for conversational pain management content to incorporate in an interactive application (app) for pain self-management. Conversational statements and questions were written as a script to encourage evidence-based pain self-management behaviors. The content was converted from text to female chatbot speech and saved as four groups of MP3 files. A purposive sample of 22 older adults participated in a guided interaction through the MP3 files. One-on-one interviews were conducted to garner participants' conversational content preferences. Overall, participants want the conversational content to increase health care provider engagement in pain management communication. Older adults preferred the inclusion of conversational statements and questions for monitoring the multifaceted dimensions of pain, treatment accountability, guidance for alternative treatments, and undesirable effects from pain treatments. The design of mobile health apps must incorporate the needs and preferences of older adults. [Journal of Gerontological Nursing, 49(1), 11-17.].

The HEART Camp Exercise Intervention Improves Exercise Adherence, Physical Function, and Patient-Reported Outcomes in Adults With Preserved Ejection Fraction Heart Failure.

BACKGROUND: Despite exercise being one of few strategies to improve outcomes for individuals with heart failure with preserved ejection fraction (HFpEF), exercise clinical trials in HFpEF are plagued by poor interventional adherence. Over the last 2 decades, our research team has developed, tested, and refined Heart failure Exercise And Resistance Training (HEART) Camp, a multicomponent behavioral intervention to promote adherence to exercise in HF. We evaluated the effects of this intervention designed to promote adherence to exercise in HF focusing on subgroups of participants with HFpEF and heart failure with reduced ejection fraction (HFrEF). METHODS AND RESULTS: This randomized controlled trial included 204 adults with stable, chronic HF. Of those enrolled, 59 had HFpEF and 145 had HFrEF. We tested adherence to exercise (defined as ≥120 minutes of moderate-intensity [40%-80% of heart rate reserve] exercise per week validated with a heart rate monitor) at 6, 12, and 18 months. We also tested intervention effects on symptoms (Patient-Reported Outcomes Measurement Information System-29 and dyspnea-fatigue index), HF-related health status (Kansas City Cardiomyopathy Questionnaire), and physical function (6-minute walk test). Participants with HFpEF (n = 59) were a mean of 64.6 ± 9.3 years old, 54% male, and 46% non-White with a mean ejection fraction of 55 ± 6%. Participants with HFpEF in the HEART Camp intervention group had significantly greater adherence compared with enhanced usual care at both 12 (43% vs 14%, phi = 0.32, medium effect) and 18 months (56% vs 0%, phi = 0.67, large effect). HEART Camp significantly improved walking distance on the 6-minute walk test (η2 = 0.13, large effect) and the Kansas City Cardiomyopathy Questionnaire overall (η2 = 0.09, medium effect), clinical summary (η2 = 0.16, large effect), and total symptom (η2 = 0.14, large effect) scores. In the HFrEF subgroup, only patient-reported anxiety improved significantly in the intervention group. CONCLUSIONS: A multicomponent, behavioral intervention is associated with improvements in long-term adherence to exercise, physical function, and patient-reported outcomes in adults with HFpEF and anxiety in HFrEF. Our results provide a strong rationale for a large HFpEF clinical trial to validate these findings and examine interventional mechanisms and delivery modes that may further promote adherence and improve clinical outcomes in this population. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov/. Unique identifier: NCT01658670.

Preferences of adults with cancer for systemic cancer treatment: do preferences differ based on age?

Background: We used the Therapy Preference Scale, a 30-item questionnaire, to determine cancer treatment preferences of adults with cancer. Methods: We used Wilcoxon's rank sum test and Fisher's exact test to compare the preferences of younger (<60 years) versus older adults (≥60 years). Results: While 56% of patients would accept treatment offering increased life expectancy at an expense of short-term side effects, 75% preferred maintenance of cognition, functional ability and quality of life to quantity of days. Oral instead of intravenous treatment (p = 0.003), shorter hospital stay (p = 0.03), preservation of cognitive function (p = 0.01) and avoidance of pain (p = 0.02) were more important to older patients compared with younger patients. Conclusion: Many patients prioritized maintenance of cognition, functional ability and quality of life; older patients valued oral treatment, shorter hospital stay, preservation of cognitive function and avoidance of pain.

Lay abstract Understanding the preferences of adults with cancer is important for physicians to develop personalized cancer treatment plans. We used a self-reported 30-item questionnaire, the Therapy Preference Scale, to help patients express their preferences with regard to safety, efficacy and other aspects of therapy. While 56% of the patients in our study would accept treatment offering increased life expectancy at an expense of short-term side effects, 75% preferred maintenance of cognition, functional ability and quality of life to quantity of days. Compared with younger patients, older patients preferred oral instead of intravenous treatment, shorter hospital stay, preservation of cognitive function and avoidance of pain.

mHealth Intervention to Improve Cardiometabolic Health in Rural Hispanic Adults: A Pilot Study.

BACKGROUND: Hispanic/Latino adults have high rates of hypertension, obesity, and type II diabetes. Mobile health technologies (mHealth) are effective in supporting self-management of lifestyle behaviors; however, the effectiveness in rural Hispanic/Latino adults is unclear. OBJECTIVE: A pilot 12-week self-management mHealth intervention in rural Hispanic/Latino adults with cardiometabolic risk was conducted. METHODS: A randomized, 2-group (intervention and enhanced usual care) design was used to test the use of the MyFitnessPal app, a smart scale, and text messages to support daily self-monitoring of weight, food intake, and steps. RESULTS: Seventy participants enrolled. The intervention group had greater improvement in body mass index ( P = .052) and waist circumference ( P = .043) at 12 weeks and a trend toward greater fitness at 12 and 24 weeks. Both groups improved hemoglobin A 1c level at 12 and 24 weeks. CONCLUSIONS: mHealth using MyFitnessPal, smart scale, and text messages may be effective for improving aspects of cardiometabolic health in rural Hispanic/Latino adults.

Mobile Health Self-management Interventions for Patients With Heart Failure: A Pilot Study.

BACKGROUND: Heart failure (HF) is a multifaceted syndrome that requires self-management for adherence to treatment to control symptoms. Symptoms need to be monitored to prevent impending HF exacerbations. Few HF study authors have assessed efficacy of mobile health (mHealth) interventions particularly with virtual visits to evaluate outcomes such as symptoms and healthcare utilization. OBJECTIVE: The aim of this pilot study was to evaluate the potential effect of mHealth self-management interventions on symptom status and health-related quality of life and describe health care utilization in patients with HF. METHODS: This 3-month pilot study included 74 patients with HF and used a randomized 3-group repeated-measures design (enhanced usual care, mHealth, and mHealth plus [+] virtual visits). Surveys included the Heart Failure Symptom Survey, EuroQol, and a specialized phone application for patients to report weights and medications. RESULTS: The mHealth groups had an overall decrease in most symptom severity and frequency, particularly shortness of breath. Compared to enhanced usual care, both the mHealth+ and mHealth groups showed promise with medium effect sizes (range .55-.60) in relation to shortness of breath and a medium effect (.51) for lower extremity edema for the mHealth+ group. There was a trend toward improvement in health-related quality of life in both intervention groups at month 3. The mHealth+ group had fewer rehospitalizations. CONCLUSIONS: In general, both mHealth groups fared better on symptoms and health care utilization. Small to medium effect sizes on selected symptom outcomes warrant this study to be conducted in a fully powered study. Virtual visits may assist in symptom recognition and self-management.

Negative Attitudes, Self-efficacy, and Relapse Management Mediate Long-Term Adherence to Exercise in Patients With Heart Failure.

BACKGROUND: Exercise is safe and provides considerable benefits for patients with heart failure (HF) including improved function, quality of life, and symptoms. However, patients with HF have difficulty initiating and adhering to an exercise regimen. To improve adherence, our team developed Heart Failure Exercise and Resistance Training (HEART) Camp, a multicomponent, theory-driven intervention that was efficacious in a randomized controlled trial of long-term adherence to exercise in patients with HF. Identifying active components of efficacious interventions is a priority. PURPOSE: The purpose of this study is to use mediation analysis to determine which interventional components accounted for long-term adherence to exercise in patients with HF. METHODS: This study included 204 patients with HF enrolled in a randomized controlled trial. Instruments measuring interventional components were completed at baseline, 6, 12, and 18 months. Hierarchical linear models generated slope estimates to be used as predictors in logistic regression models. Significant variables were tested for indirect effects using path analyses with 1,000 bootstrapped estimates. RESULTS: Significant mediation effects were observed for the interventional components of negative attitudes (ß NA = 0.368, s.e. = 0.062, p < .001), self-efficacy (ß SE = 0.190, s.e. = 0.047, p < .001), and relapse management (ß RM = 0.243, s.e. = 0.076, p = .001). CONCLUSIONS: These findings highlight improving attitudes, self-efficacy, and managing relapse as key interventional components to improve long-term adherence to exercise in patients with HF. Future interventions targeting adherence to exercise in patients with HF and other chronic illnesses should consider the incorporation of these active components.

Development and validation of the Therapy Preference Scale to understand patients´ systemic cancer treatment preferences.

We incorporated questions related to safety, effectiveness and other characteristics of systemic cancer treatment into a self-report questionnaire - the Therapy Preference Scale - that captures patients´ preferences. The authors asked 20 experts to assess content validity and an additional 20 experts, patients and community members to examine face validity and guide revisions. Key revisions included shortening the length, clarifying constructs and providing details to explain the context and trade-offs necessary to balance the risks and benefits of cancer treatment. The content validity index for the final questionnaire was 1.0, indicating that all questions were relevant. Reviewers expressed that the questionnaire would serve an important purpose. Experts, patients and community members guided revisions of the questionnaire and documented its value.

Health-Related Quality of Life in Patients With a Left Ventricular Assist Device (QOLVAD) Questionnaire: Initial Psychometrics of a New Instrument.

BACKGROUND: Patients with a left ventricular assist device are a unique and growing population who deserve their own valid, reliable instrument for health-related quality of life. OBJECTIVE: We developed and tested the Health-Related Quality of Life with a Left Ventricular Assist Device (QOLVAD) questionnaire. METHODS: In a prospective, descriptive study, patients from 7 sites completed the QOLVAD and comparator questionnaires. Construct validity was tested using confirmatory factor analysis. Convergent validity was tested using correlations of QOLVAD scores to well-established measures of subjective health status, depression, anxiety, and meaning/faith. Reliability and test-retest reliability were quantified. RESULTS: Patients (n = 213) were 58.7 ± 13.9 years old; 81.0% were male, 73.7% were White, and 48.0% had bridge to transplant. Questionnaires were completed at a median time of 44 weeks post ventricular assist device. The 5 QOLVAD domains had acceptable construct validity (root mean square error of approximation = 0.064, comparative and Tucker-Lewis fit indices > 0.90, weighted root mean square residual = 0.95). The total score and domain-specific scores were significantly correlated with the instruments to which they were compared. Internal consistency reliability was acceptable for all subscales (α = .79-.83) except the cognitive domain (α = .66). Unidimensional reliability for the total score was acceptable (α = .93), as was factor determinacy for multidimensional reliability (0.95). Total test-retest reliability was 0.875 (P < .001). CONCLUSION: Our analysis provided initial support for validity and reliability of the QOLVAD for total score, physical, emotional, social, and meaning/spiritual domains. The QOLVAD has potential in research and clinical settings to guide decision making and referrals; further studies are needed.

A longitudinal comparison of health-related quality of life in rural and urban recipients of left ventricular assist devices.

Left ventricular assist devices (LVAD) are a common treatment for advanced heart failure (HF) to improve ventricular function, symptoms, and health-related quality of life (HRQOL). Many LVAD recipients travel long distances from rural areas for LVAD implantation and follow-up care. Individuals with HF in rural settings who have not undergone LVAD implantation have reported poor HRQOL. However, to date, no studies have compared HF-specific or generic HRQOL in rural and urban LVAD recipients. The purpose of this study was to compare generic and HF-specific HRQOL longitudinally from preimplantation to 1-, 3-, and 6- months postimplant in a cohort of rural and urban LVAD recipients (n = 95; rural n = 32 and urban n = 63). We measured generic HRQOL using the European Quality of Life Visual Analog Scale and HF-specific HRQOL with the quality of life domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ). Latent growth curve modeling identified two phases of change in generic and HF-specific HRQOL: the initial response to LVAD between preimplantation and 1-month postimplant and the subsequent change between 1- and 6-months postimplant. Comparable improvements in generic HRQOL were noted in rural and urban LVAD recipients during both phases of change. Urban LVAD recipients had greater initial improvements in HF-specific HRQOL (KCCQ) compared with rural recipients (13.0 ± 5.6, p = .02), but subsequent improvements were similar among rural and urban recipients. Ongoing assessment of generic and HF-specific HRQOL is necessary during LVAD therapy.

Depressive Symptoms in Women With Coronary Heart Disease: A Systematic Review of the Longitudinal Literature.

BACKGROUND: Interpreting studies about women with coronary heart disease and depressive symptoms is challenging: women continue to be underrepresented in research; data are often not presented separately by sex; many studies do not examine depressive symptoms longitudinally, leaving our understanding incomplete; and the use of multiple depressive symptom assessment instruments makes comparisons between studies problematic. PURPOSE: The authors of this systematic review examined 20 longitudinal descriptive studies on women with coronary heart disease and depressive symptoms, including prevalence of elevated symptoms, changes in symptoms over time, findings in women versus men, and findings based on assessment instruments. CONCLUSIONS: The prevalence of elevated depressive symptoms in women was 35.75% at baseline (hospitalization). The Beck Depression Inventory II yielded the highest baseline prevalence (40.3%), slightly higher than the Depression Interview and Structured Hamilton Scale (36%). The Hospital Anxiety and Depression Scale and the Kellner questionnaire yielded much lower prevalence (21.45% and 23%, respectively). Higher prevalence was linked to inclusion of somatic symptoms on measurement instruments except in post-coronary bypass surgery patients. Symptoms trended toward improvement, particularly in the first 6 months, although a few studies measured beyond this time. Women demonstrated higher prevalence than men initially (35.75% vs 23.46%, respectively) and over 24 months (22.71% vs 19.82%, respectively). CLINICAL IMPLICATIONS: Women experienced significantly more depressive symptoms than men initially and over time, although most women's symptoms improved. Measurement varies widely based on instrument and the inclusion/exclusion of somatic symptoms. More longitudinal studies beyond 6 months with prevalence data and analysis by sex/gender are needed.

Adverse-Event Free Survival, Hospitalizations, and Mortality in Left Ventricular Assist Device Recipients: A Rural-Urban Cohort Comparison.

BACKGROUND: The number of individuals with advanced heart failure (HF) receiving left ventricular assist devices (LVADs) is growing. Postimplantation LVAD recipients return home to both rural and urban locations. The impact of rural or urban living on postimplantation outcomes has not been adequately explored. OBJECTIVE: This cohort study examined adverse event-free survival, hospitalization-free survival, and all-cause mortality between rural and urban LVAD recipients in the first 2 years after implantation. METHODS: Data from LVAD recipients (N = 141) implanted at a single center in the northeastern United States were analyzed. Recipients of LVAD were designated as rural or urban by county of residence. Adverse events, hospitalizations, and survival time were examined using multivariate Cox proportional hazards models. RESULTS: Thirty-seven percent of LVAD recipients in the cohort were rural. Two-thirds of all LVAD recipients experienced at least 1 adverse event (96/141, 68.1%). Although more urban recipients experienced adverse events, including death, rural versus urban models of both adverse events and survival were nonsignificant (adverse events: log-rank = 1.18, P = .28; hazard ratio [HR], 0.96; 95% confidence interval [CI], 0.57-1.63; P = .89; survival: log-rank =2.81, P = .09; HR, 0.45; 95% CI, 0.17-1.23; P = .12). Rural LVAD recipients experienced significantly more hospitalizations and shorter hospitalization-free survival (log-rank = 6.67, P = .009). However, the HR for survival was nonsignificant (HR, 1.5; 95% CI, 0.94-2.39; P = .08). CONCLUSIONS: Frequent adverse events and hospitalizations are of ongoing concern for LVAD recipients. More data are necessary to understand why urban LVAD recipients may experience shorter survival time compared with rural counterparts. Hospitalization may serve as a protective factor for rural LVAD recipients.

Incorporating intervention fidelity components into randomized controlled trials promoting exercise adherence in heart failure patients.

Intervention fidelity (IF) in behavioral interventions is complicated by their dynamic and interactive nature. Translation of the outcomes to practice may be diminished by lack of fidelity. The purpose of this paper is to describe a systematic, evidence-based IF approach in a complex, multicomponent behavioral change study. The National Institutes of Health-funded randomized controlled trial was designed to evaluate the effect of an adherence to exercise intervention. Two hundred forty-six heart failure patients from two sites were enrolled. This description of the study-specific standardized protocol, the data collection methods used, findings from the plan, and the discussion of the successes and challenges contributes to the advancement of IF implementation science.

Effects of the HEART Camp Trial on Adherence to Exercise in Patients With Heart Failure.

BACKGROUND: Few exercise training studies in patients with heart failure (HF) report adherence to guideline-recommended 150 minutes of moderate-intensity exercise per week, and no studies have focused on a primary outcome of adherence. METHODS AND RESULTS: This randomized controlled trial evaluated the effect of a multicomponent intervention, Heart Failure Exercise and Resistance Training (HEART) Camp, on adherence to exercise (after 6, 12, and 18 months) compared with an enhanced usual care (EUC) group. Patients (n = 204) were 55.4% male, overall average age was 60.4 years, and 47.5% were nonwhite. The HEART Camp group had significantly greater adherence at 12 (42%) and 18 (35%) months compared with the EUC group (28% and 19%, respectively). No significant difference (P > .05) was found at 6 months. The treatment effect did not differ based on patient's age, race, gender, marital status, type of HF (preserved or reduced ejection fraction) or New York Heart Association functional class. Left ventricular ejection fraction (LVEF) significantly moderated the treatment effect, with greater adherence at higher LVEF. CONCLUSIONS: The multicomponent HEART Camp intervention showed efficacy with significant effects at 12 months and 18 months. Adherence levels remained modest, indicating a need for additional research to address methods and strategies to promote adherence to exercise in patients with HF.

Methodological strategies in using home sleep apnea testing in research and practice.

PURPOSE: Home sleep apnea testing (HSAT) has increased due to improvements in technology, accessibility, and changes in third party reimbursement requirements. Research studies using HSAT have not consistently reported procedures and methodological challenges. This paper had two objectives: (1) summarize the literature on use of HSAT in research of adults and (2) identify methodological strategies to use in research and practice to standardize HSAT procedures and information. METHODS: Search strategy included studies of participants undergoing sleep testing for OSA using HSAT. MEDLINE via PubMed, CINAHL, and Embase with the following search terms: "polysomnography," "home," "level III," "obstructive sleep apnea," and "out of center testing." RESULTS: Research articles that met inclusion criteria (n = 34) inconsistently reported methods and methodological challenges in terms of: (a) participant sampling; (b) instrumentation issues; (c) clinical variables; (d) data processing; and (e) patient acceptability. Ten methodological strategies were identified for adoption when using HSAT in research and practice. CONCLUSIONS: Future studies need to address the methodological challenges summarized in this paper as well as identify and report consistent HSAT procedures and information.

Accelerometer-Measured Daily Activity Levels and Related Factors in Patients With Heart Failure.

BACKGROUND: Few studies report objective accelerometer-measured daily physical activity levels in patients with heart failure (HF). OBJECTIVE: We examined baseline accelerometer-measured physical activity from the Heart Failure Exercise and Resistance Training Camp trial, a federally funded (R01-HL112979) 18-month intervention study to promote adherence to exercise in patients with HF. Factors associated with physical activity levels were also explored. METHODS: Patients with diagnosed HF (stage C chronic HF confirmed by echocardiography and clinical evaluation) were recruited from 2 urban medical centers. Physical activity energy expenditure and the number of minutes of moderate or vigorous physical activity (MVPA) were obtained from 7 full days of measurement with the accelerometer (Actigraph Model GT3X, Pensacola, Florida) for 182 subjects who met minimum valid wear time parameters. Additional measures of health-related factors were included to explore the association with physical activity levels. RESULTS: Subjects had 10.2 ± 10.5 minutes of MVPA per day. Total physical activity energy expenditure was 304 ± 173 kcal on average per day. There were 23 individuals (12.6%) who met the recommended goal of 150 minutes of MVPA per week. Men, whites, New York Heart Association class II, and subjects with better physical function had significantly higher levels of activity. CONCLUSIONS: Consistent with previous research, patients with HF are not meeting recommended guidelines for 150 minutes of MVPA per week.

Adherence to recommended exercise guidelines in patients with heart failure.

Exercise training has been shown to be beneficial in patients with heart failure, and its effectiveness is connected to adherence to the exercise program. Nonetheless, adherence to exercise in these patients remains a concern. Heart failure patients can be considered adherent to an exercise program if they meet 80 % of the recommended dose. We summarize exercise recommendations for patients with heart failure, identify exercise prescription methodologies used in studies that have reported exercise adherence, identify strategies and tools used to improve adherence and examine whether these strategies were developed using a theoretical platform with the primary aim to change behavior and improve adherence to exercise. Factors which may also impact adherence such as exercise setting, intensity and length of participation, gender, race, New York Heart Association functional class and heart failure with preserved and reduced ejection fraction were also investigated. Finally, recommendations for future studies for improving adherence to exercise in patients with heart failure are provided.

Sleep and health-related factors in overweight and obese rural women in a randomized controlled trial.

This secondary analysis describes sleep and health-related factors in healthy overweight and obese mid-life and older rural women enrolled in the" Women Weigh-In for Wellness" randomized clinical trial. The aim of the trial was to promote healthy behaviors and weight-loss. We analyzed demographic, anthropometric, and biomarker variables, self-reported measurements of sleep disturbance and pain interference, and objective 24-h sleep/wake patterns at baseline, 6 months, and the change over time. Although self-reported sleep disturbance reflected normal sleep, pain interference was slightly higher than normal. There were associations between higher self-reported sleep disturbance, pain interference and several other variables. Women who achieved 5 % or more weight loss exhibited positive associations between sleep, pain, and health-related factors. Weight loss and lower pain predicted lower self-reported sleep disturbance. Our results suggest that overweight and obese rural women who adopt healthy behaviors and achieve weight loss also may experience improved sleep and other health benefits. Clinical trial # NCT01307644.

Team-based Care for Cardiac Rehabilitation and Exercise Training in Heart Failure.

The estimated cost of treating patients with HF in the United States is expected to more than double by 2030.65 This forecast of the impact of HF in the United States should serve as a call to action. Despite well-documented benefits, participation in exercise training and CR programs by patients with HF remains low. In this article, standards and guidelines for exercise and CR in HF were reviewed. Although traditional CR had core components, it lacked care management specific for HF. Chronic stable HF patients can safely exercise; however, there are many unique needs that are not currently addressed at the patient, system, and provider levels. As we face economic and political forces that are expected to require major change to the health care delivery system, it becomes even more important to capitalize on the advantages that come with team-based care. CR has always served as a model of team-based care; however, the model must now include professionals with HF expertise to guide patients in safe exercise and self-management strategies appropriate for this chronically ill population.