A Mobile Health Intervention to Increase Physical Activity in Pulmonary Arterial Hypertension

doi:10.1016/j.chest.2021.04.012

Chest

Volume 160, Issue 3, September 2021, Pages 1042-1052

https://doi.org/10.1016/j.chest.2021.04.012 Get rights and content

Background

Supervised exercise training improves outcomes in patients with pulmonary arterial hypertension (PAH). The effect of an unsupervised activity intervention has not been tested.

Research Question

Can a text-based mobile health intervention increase step counts in patients with PAH?

Study Design and Methods

We performed a randomized, parallel arm, single-blind clinical trial. We randomized patients to usual care or a text message-based intervention for 12 weeks. The intervention arm received three automated text messages per day with real-time step count updates and encouraging messages rooted in behavioral change theory. Individual step targets increased by 20% every 4 weeks. The primary end point was mean week 12 step counts. Secondary end points included the 6-min walk test, quality of life, right ventricular function, and body composition.

Results

Among 42 randomized participants, the change in raw steps between baseline and week 12 was higher in the intervention group (1,409 steps [interquartile range, –32 to 2,220] vs –149 steps [interquartile range, –1,010 to 735]; P = .02), which persisted after adjustment for age, sex, baseline step counts, and functional class (model estimated difference, 1,250 steps; P = .03). The intervention arm took a higher average number of steps on all days between days 9 and 84 (P < .05, all days). There was no difference in week 12 six-minute walk distance. Analysis of secondary end points suggested improvements in the emPHasis-10 score (adjusted change, –4.2; P = .046), a reduction in visceral fat volume (adjusted change, –170 mL; P = .023), and nearly significant improvement in tricuspid annular plane systolic excursion (model estimated difference, 1.2 mm; P = .051).

Interpretation

This study demonstrated the feasibility of an automated text message-based intervention to increase physical activity in patients with PAH. Additional studies are warranted to examine the effect of the intervention on clinical outcomes.

Clinical Trial Registration

ClinicalTrials.gov; No. NCT03069716; URL: www.clinicaltrials.gov

Graphical Abstract

Section snippets

Study Design

This study was a randomized, single-blind, controlled pilot trial of a text-based mobile health intervention in patients with PAH conducted between October 2017 and April 2020. This study was approved by the Vanderbilt Institutional Review Board (#162004) and was monitored by an independent Data Safety and Monitoring Board. All participants gave written informed consent. The trial was registered before recruitment began.¹⁰ Study activities occurred at Vanderbilt University Medical Center.

Results

Among 89 patients with PAH screened for eligibility, we enrolled 48 participants (Fig 1). Six individuals dropped out during the run-in period and before randomization, and two participants dropped out after randomization. Reasons for dropping out before randomization included personal reasons/difficulty scheduling visits (n = 4), an unrelated serious adverse event (n = 1), and escalation of PAH therapy (n = 1). Reasons for dropping out after randomization included personal reasons (n = 1) and

Discussion

We tested the feasibility of increasing daily step counts in patients with PAH, using an automated “smart” text message-based mobile health intervention built on real-time monitoring of step counts. We found the target population to be enthusiastic to enroll and highly adherent with a low dropout rate. The intervention was associated with an increase of more than 1,000 steps/d (approximately 0.5 mile) at 12 weeks compared with the usual care arm. Among secondary end points, the intervention

Interpretation

We demonstrated the feasibility of an automated text-based, unsupervised mobile health intervention to increase step counts in patients with PAH. The intervention was inexpensive, safe, well tolerated, and met with high enthusiasm by the target population as evident by enrollment of more than one-half of those approached. Exploratory analyses suggest potential for this intervention to improve quality of life and right ventricular function. Future, adequately powered studies are warranted to

Acknowledgments

Author contributions: E. L. B. takes responsibility for the data and analysis. Conception or design (A. R. H., S. S. M., M. J. B., C. Y., and E. L. B.); data acquisition (L. S.-L., G. MacK., J. A., C. S. W., R. M., R. N. O., R. H., R. S., P. P. H., and E. L. B.); data analysis (S. H., C. Y., and E. L. B.); interpretation of data (A. R. H., L. S.-L., S. H., G. MacK., C. Y., S. S. M., M. J. B., and E. L. B.); drafting or revising the work (all of the authors); final approval (all of the authors);

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Cited by (14)

Data-Driven and Technology-Enabled Trial Innovations Toward Decentralization of Clinical Trials: Opportunities and Considerations
2023, Mayo Clinic Proceedings
Traditional trial designs have well-recognized inefficiencies and logistical barriers to participation. Decentralized trials and digital health solutions have been suggested as potential solutions and have certainly risen to the challenge during the pandemic. Clinical trial designs are now increasingly data driven. The use of distributed clinical data networks and digitization has helped to fundamentally upgrade existing research systems. A trial design may vary anywhere from fully decentralized to hybrid to traditional on-site. Various decentralization components are available for stakeholders to increase the reach and pace of their trials, such as electronic informed consent, remote interviews, administration, outcome assessment, monitoring, and laboratory and imaging modalities. Furthermore, digital health technologies can be included to enrich study conduct. However, careful consideration is warranted, including assessing verification and validity through usability studies and having various contingencies in place through dedicated risk assessment. Selecting the right combination depends not just on the ability to handle patient care and the medical know-how but also on the availability of appropriate technologic infrastructure, skills, and human resources. Throughout this process, quality of evidence generation and physician-patient relation must not be undermined. Here we also address some knowledge gaps, cost considerations, and potential impact of decentralization and digitization on inclusivity, recruitment, engagement, and retention. Last, we mention some future directions that may help drive the necessary change in the right direction.
Assessing Daily Life Physical Activity by Actigraphy in Pulmonary Arterial Hypertension: Insights From the Randomized Controlled Study With Selexipag (TRACE)
2023, Chest
Citation Excerpt :
The fact that TRACE patients were not encouraged to increase their activity may have contributed to the limited changes to DLPA parameters. Indeed, home-based intervention programs for patients with PAH can result in an increased intensity of DLPA,38 which should be considered in future trials in which DLPA is measured to evaluate a treatment effect. Common barriers to physical activity reported by patients with PAH include “lack of energy, lack of self-discipline, and lack of interest” in exercise,39 and interventions to address these barriers could also be considered in future trials.
Reduced daily life physical activity (DLPA) in pulmonary arterial hypertension (PAH) contributes to a poor quality of life.
Can actigraphy be used to assess changes in DLPA in patients with PAH receiving selexipag or placebo?
Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension (TRACE) was a prospective, multicenter, randomized, placebo-controlled, double-blind, exploratory phase 4 study enrolling patients with PAH in World Health Organization functional class II/III, receiving stable endothelin receptor antagonist with/without phosphodiesterase type 5 inhibitor background therapy. Primary end points were change from baseline to Week 24 in actigraphy-assessed DLPA (recorded by using an accelerometer), including daily time spent in nonsedentary physical activity (NSPA), daily time spent in moderate to vigorous physical activity (MVPA), daily volume of activity, and daily number of steps.
At baseline, patients (N = 108) were prevalent, on stable background PAH therapy, and at low risk of disease progression. Patients showed high compliance with wear of the accelerometer throughout the study. From baseline to Week 24, mean daily time spent in NSPA increased by 1.1 min and decreased by 16.7 min in the selexipag and placebo groups (treatment difference [95% CI], 17.8 [–6.0, 41.6] min); mean time spent in MVPA increased by 0.3 min and was reduced by 2.0 min in the selexipag and placebo groups (treatment difference [95% CI], 2.3 [–10.8, 15.4] min); and mean number of daily steps decreased by 0.3 and 201.9 in the selexipag and placebo groups (treatment difference [95% CI], 201.6 [–243.0, 646.2]).
TRACE enrolled a prevalent population on background therapy and at low risk of disease progression. Changes in DLPA were small and highly variable, with no statistically significant differences between treatment groups. This patient-centric study was the first randomized trial in PAH to capture high-quality actigraphy data and to describe DLPA in terms of mean/median and variability, which may inform the design of future studies.
ClinicalTrials.gov; No.: NCT03078907; URL: www.clinicaltrials.gov
The rise of AI in telehealth
2023, Emerging Practices in Telehealth: Best Practices in a Rapidly Changing Field
Since its introduction in 1955, artificial intelligence (AI) has continued its growth and expansion across all industries and societal sectors. It took the COVID-19 pandemic for AI and its subsets to take the center stage in medicine and health care. AI is a broad discipline and encompasses machine learning (ML), deep learning (DL), and other techniques. Advancements in AI enabled, facilitated, and accelerated the expansion of telehealth. Telehealth describes the wide array of digital information and communication technologies and systems that allow the delivery of health and health-related services. There are three distinct subtypes of telehealth: synchronous, asynchronous, and remote (tele) monitoring. The overarching goal of telehealth is to break down barriers in delivery of high value care by overcoming challenges resulting from time or location constraints. The end goal is not to replace in-person care, rather to commoditize and democratize high quality, high value care. On the other hand, there remain significant limitations and pitfalls, particularly regulatory and technological. Examples include best practice guidelines on the adaptation of standards regulating data exchange, expansion of reimbursement and importantly ethical challenges. The latter include critical issues such as data privacy, security, and governance, AI-introduced bias, the black box nature of some AI/ML algorithms and the impact of AI technologies/algorithms on health disparities and inequities. Disparities in access to and use of tele-health were already known but highlighted during the COVID-19 pandemic. Recognition of this hurdle led to the emerging and rapidly growing field of digital determinants of health, which comprise factors like digital literacy, access to AI/technology, and community infrastructure like access to WiFi/broadband internet.
The evolving landscape of pulmonary arterial hypertension clinical trials
2022, The Lancet
Citation Excerpt :
The TRACE trial99 measured step counts with actigraphy as an endpoint and showed the feasibility of actigraphy within the context of a pulmonary arterial hypertension trial, but found no significant difference in daily step counts or non-sedentary activity between add-on selexipag and placebo groups. Another recent feasibility trial found that actigraphy-measured step counts were responsive to a mobile health intervention, demonstrating that such endpoints can be sensitive to interventions in patients with pulmonary arterial hypertension.100 Potential challenges to using actigraphy can be extrapolated from heart failure trials.
Although it is a rare disease, the number of available therapeutic options for treating pulmonary arterial hypertension has increased since the late 1990s, with multiple drugs developed that are shown to be effective in phase 3 randomised controlled trials. Despite considerable advancements in pulmonary arterial hypertension treatment, prognosis remains poor. Existing therapies target pulmonary endothelial dysfunction with vasodilation and anti-proliferative effects. Novel therapies that target proliferative vascular remodelling and affect important outcomes are urgently needed. There is need for additional innovations in clinical trial design so that all emerging candidate therapies can be rigorously studied. Pulmonary arterial hypertension trial design has shifted from short-term submaximal exercise capacity as a primary endpoint, to larger clinical event-driven trial outcomes. Event-driven pulmonary arterial hypertension trials could face feasibility and efficiency issues in the future because increasing sample sizes and longer follow-up durations are needed, which would be problematic in such a rare disease. Enrichment strategies, innovative and alternative trial designs, and novel trial endpoints are potential solutions that could improve the efficiency of future pulmonary arterial hypertension trials while maintaining robustness and clinically meaningful evidence.
Considerations When Selecting Patient-Reported Outcome Measures for Assessment of Health-Related Quality of Life in Patients With Pulmonary Hypertension: A Narrative Review
2022, Chest
Citation Excerpt :
All four PROMs were content validated in samples of patients with PAH,16-19,22 whereas validation samples for CAMPHOR, PAH-SYMPACT, and emPHasis-10 also included patients with CTEPH.16,18,23 Table 416-18,22,24-55 summarizes findings related to the evaluation of psychometric properties for PH-specific PROMs. Detailed descriptions of findings for each PROM are provided in e-Appendix 3.
It is well established that pulmonary hypertension (PH) places a substantial burden on patients’ health-related quality of life (HRQoL). As more effective treatments have been developed for this condition, evaluating treatment benefit based on experiences reported by patients regarding their well-being and physical, social, and emotional functioning has increased. A review of the published literature and clinical trials in PH was conducted to identify and evaluate patient-reported outcome measures (PROMs) that assess PH-specific HRQoL for use in clinical studies. The Cambridge Pulmonary Hypertension Outcome Review, emPHasis-10, Living with Pulmonary Hypertension Questionnaire, and Pulmonary Arterial Hypertension—Symptoms and Impact were selected for in-depth evaluation with respect to their content validity, psychometric properties, interpretation guidelines, conceptual coverage, and administrative feasibility. Recommendations for clinical study end point strategies are provided. The review identified many strengths for each of the PROMs. Content development for all PROMs followed best practices, and any weaknesses in assessment of measurement properties were from a scarcity of available data. Although conceptual coverage and patient burden varied greatly across the PROMs, each provided a unique strength relative to the others, and no one PROM was recommended as most appropriate across all contexts of use. Optimal end point selection for assessing PH-specific HRQoL thus requires consideration of the purpose and situation in which the assessment will be conducted. These recommendations should be considered as a snapshot of a quickly evolving landscape that should be updated as new information emerges.
Text messages promoting healthy lifestyle and linked with activity monitors stimulate an immediate increase in physical activity among women after gestational diabetes
2022, Diabetes Research and Clinical Practice
Citation Excerpt :
One study, conducted among patients in an ambulatory cardiology centre, found that 3 daily text messages encouraging attainment of a step target and supporting cardiovascular knowledge increased daily step count by 2500 over a period of 2 weeks, compared to patients who did not receive text messages [23]. A study using a similar protocol, among patients with pulmonary arterial hypertension, found that the intervention increased step count by about 1400 steps a day, over 12 weeks compared to subjects who did not receive text messages [24]. A study conducted among university students, linked phone pedometer data with motivational and feedback messages.
To evaluate the immediate effect of text messages promoting healthy lifestyle and supporting parenting on physical activity amongst women with recent gestational diabetes (GDM).
Analysis of data from a pilot randomised controlled trial of a healthy lifestyle program for women with recent GDM. Intervention subjects received text messages providing motivation, reminders, information and feedback as well as an activity monitor. This sub-study examined step count in the 4 h after receipt of a text message, compared to the same time of day on other days among intervention subjects.
Data from 7326 days where step counts were recorded, from 31 women were analysed. The median steps in the 4 h following a text message was 1237 (IQR 18–2240) and it was 1063 (IQR 0–2038) over the same time period on comparison days where there was no message (p < 0.001). The effect was similar whether the messages pertained to physical activity or not. There was no attenuation of the response over 36–38 weeks.
Women with recent GDM increase their step count in the hours following positive and supportive text messages. This suggests that text messaging programs can facilitate healthy lifestyle and diabetes prevention in this population.

View all citing articles on Scopus

: FUNDING/SUPPORT: NIH grant R34HL136989 (E. L. B.); Aetna Foundation (L. S.-L., S. S. M., M. J. B.).

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Chest

Pulmonary Vascular: Original ResearchA Mobile Health Intervention to Increase Physical Activity in Pulmonary Arterial Hypertension

Background

Research Question

Study Design and Methods

Results

Interpretation

Clinical Trial Registration

Graphical Abstract

Section snippets

Study Design

Results

Discussion

Interpretation

Acknowledgments

J Card Fail

Respir Med

Chest

Int J Cardiol

Effect of exercise and respiratory training on clinical progression and survival in patients with severe chronic pulmonary hypertension

Respiration

Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension

Circulation

Efficacy and safety of exercise training in chronic pulmonary hypertension: a systematic review and meta-analysis

Circ Heart Fail

Effect of lifestyle-focused text messaging on risk factor modification in patients with coronary heart disease: a randomized clinical trial

JAMA

Effect of inorganic nitrite vs placebo on exercise capacity among patients with heart failure with preserved ejection fraction: the INDIE-HFpEF randomized clinical trial

JAMA

Isosorbide mononitrate in heart failure with preserved ejection fraction

N Engl J Med

mActive: a randomized clinical trial of an automated mHealth intervention for physical activity promotion

J Am Heart Assoc

Pulmonary Vascular: Original Research
A Mobile Health Intervention to Increase Physical Activity in Pulmonary Arterial Hypertension