Think Aloud Testing of a Smartphone App for Lifestyle Change Among Persons at Risk of Type 2 Diabetes: Usability Study.

BACKGROUND: Type 2 diabetes mellitus (DM2) is a leading cause of morbidity and mortality worldwide and is considered a global epidemic. Despite the growing evidence on the effectiveness of mobile health interventions in the management of DM2, the evidence on the effect of mobile health interventions in prevention of DM2 is sparse. Therefore, we have developed an app aiming to promote initiation of behavioral change and adherence to healthy behavior. Before commencing a small-scale randomized controlled trial to assess the feasibility of using an app for initiation and adherence of healthy behavior in people at risk of DM2, testing the usability of the app in the target population is warranted. OBJECTIVE: The aim of this study was to assess the usability of an app among people at risk of DM2. METHODS: A qualitative study with the use of a think aloud (TA) procedure was conducted from April to November 2022. The TA procedure consisted of 10 problem-solving tasks and a semistructured interview which was carried out after the tasks. These interviews served to gain more in-depth knowledge of the users experience of the problem-solving tasks. The TA-sessions and the postactivity interviews were recorded and transcribed verbatim, and the data were coded and analyzed following the principles of thematic analysis. RESULTS: In total, 7 people at risk of DM2 with a median age of 66 (range 41-75) years participated in this study. The analysis resulted in the following themes: (1) user interface design; and (2) suggestions for improvements of the functionality of the app. CONCLUSIONS: Overall, the participants were satisfied with the usability of the app. Through the TA-sessions, real time perspective on the appeal, relevance, and utility of the app were gained. Only minor changes to the functionality of the prototype app were reported as necessary to improve the usability of the app. Points of guidance from the participants in this study have been adopted and incorporated into the final design of the app now being assessed for feasibility in a small-scale randomized controlled trial.

Patients' Experiences of Using a Smartphone App After Cardiac Rehabilitation: Qualitative Study.

BACKGROUND: Exercise-based cardiac rehabilitation (CR) is a crucial part of the treatment of patients with cardiac diseases, and adherence to healthy behavior is a prerequisite to improve long-term prognosis. Unfortunately, adherence to healthy behavior adapted in CR is challenging for many cardiac patients in the long term. Recently, we demonstrated that follow-up conducted via an app for 1 year significantly improved adherence to healthy behavior after CR. To increase the knowledge and understanding of mobile Health (mHealth) interventions that can promote acceptance and adherence, qualitative research investigating patients' experiences with these interventions is warranted. OBJECTIVE: The aim was to investigate patient experiences with individualized long-term follow-up conducted via an app for 1 year and their thoughts about what features promoted adherence to healthy behavior after CR. The purpose was to increase the understanding of significant findings previously reported and to guide future development of similar interventions in the field of adherence. METHODS: A qualitative study with individual interviews was conducted from November 2018 to May 2019. A thematic interview guide was used when conducting the semistructured in-depth interviews. The interviews were audio recorded and transcribed successively during the period in which the interviews were conducted. Texts were managed and systematized by NVivo. Interviews were analyzed by qualitative content analysis. Codes and themes were inductively developed. RESULTS: Ten patients who had participated in a randomized controlled trial evaluating the effect of follow-up conducted via an app on adherence to healthy behavior after CR were included. The median patient age was 65 years (range 46-72 years), and both genders were represented. The analysis resulted in the following 4 themes describing the patients' experiences: (1) The person behind the app is crucial for motivation and adherence; (2) The app as a commitment; (3) The app as a path to independence; and (4) Suggestions for improvements. Features experienced as beneficial to promote adherence were individualized feedback and the use of goal setting. The significance of the person behind the app (the supervisor) who provided individualized feedback was a consistent finding. This person seemed to promote motivation in general and to enable other known behavioral change techniques. CONCLUSIONS: The person behind the app (the supervisor) seems to be one of the most significant success factors in promoting adherence to healthy behavior after CR. This indicates that a health care provider must actively participate in a patient's process of adherence to healthy behavior, even when using interventions, including an app. Future development of interventions in the field of adherence should strive to create tools that enable an ongoing collaborative relationship between the patient and the health care provider. The follow-up should be based on the patient's own goals, and individualized feedback should be provided.

Long-term follow-up with a smartphone application improves exercise capacity post cardiac rehabilitation: A randomized controlled trial.

BACKGROUND: Mobile health interventions, especially smartphone applications (apps), have been proposed as promising interventions for supporting adherence to healthy behaviour in patients post cardiac rehabilitation (CR). The overall aim of the study was to examine the effect of individualized follow-up with an app for one year on peak oxygen uptake (VO2peak) in patients completing CR. DESIGN: The study was designed as a single-blinded multicentre randomized controlled trial. METHODS: The intervention group (IG) received individualized follow-up enabled with an app for one year, while the control group (CG) received usual care. The primary outcome was difference in VO2peak. Secondary outcomes included exercise performance (time to exhaustion, peak incline (%) and peak velocity (km/h)), bodyweight, resting blood pressure, lipid profile, triglycerides, exercise habits, health-related quality of life, health status and self-perceived goal achievement. RESULTS: In total, 113 patients completing CR (73.4% with coronary artery disease, 16.8% after valve surgery and 9.8% with other heart diseases) were randomly allocated to the IG or CG. Intention to treat analyses showed a statistically significant difference in VO2peak between the groups at follow-up of 2.2 ml/kg/min, 95% confidence interval 0.9-3.5 (p < 0.001). Statistically significant differences were also observed in exercise performance, exercise habits and in self-perceived goal achievement. CONCLUSIONS: Individualized follow-up for one year with an app significantly improved VO2peak, exercise performance and exercise habits, as well as self-perceived goal achievement, compared with a CG in patients post-CR. There were no statistically significant differences between the groups at follow-up in the other outcome measures evaluated.

Effects of individualized follow-up with a smartphone-application after cardiac rehabilitation: protocol of a randomized controlled trial.

BACKGROUND: Cardiac rehabilitation (CR) programs are evidence-based and widely recommended. However, benefits from CR are likely lost among individuals who discontinue their regular exercise routines and healthy habits. One possible approach to enhance adherence to lifestyle advice after completion of CR, may be individualized follow-up enabled by a smartphone application (app). METHODS: A protocol of a single-blinded, pragmatic randomized controlled trial. The study will take place in the eastern part of Norway, and will include heart patients who have completed CR. Participants will be recruited from two CR centers. Based on power calculation, 113 participants will be included. The intervention group will receive individualized follow-up through an app on a weekly basis throughout a year. The app will be set up with the participant's own goals, and the follow-up will be based on these individual goals. The control group will receive usual care, including general advice regarding physical activity, exercise and diet. The participants will be assessed at baseline (at completion of CR) and 12 months after baseline. Primary outcome of the study will be peak oxygen uptake. Secondary outcomes include exercise performance, quality of life, health status, health literacy, self-perceived goal achievement, exercise habits, body weight, blood pressure as well as lipids and triglycerides. DISCUSSION: To our knowledge, this will be the first study to examine the effects of individualized follow-up with an app for one year, in patients completing CR. Hence, it is reasonable to assume that the study may be groundbreaking. Due to the large sample size and the theoretically based intervention, the study has the potential to generate new knowledge that may improve the design of future technology-based follow-up interventions of patients that have completed rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov. NCT03174106. First registration, 19/05/2017.

Feasibility of a Mobile Phone App to Promote Adherence to a Heart-Healthy Lifestyle: Single-Arm Study.

BACKGROUND: Long-term maintenance of preventive activities is fundamental for achieving improved outcomes in cardiac rehabilitation (CR). Despite this, it has been shown to be a major challenge for many patients to follow recommendations and thereby adhere to a heart-healthy lifestyle. Mobile phone apps have been emphasized as potential tools to promote preventive activities after attendance in a CR program. Before commencing a trial to assess the potential effect of using an app to promote long-term adherence to preventive activities after attendance in CR, a study to assess if it is feasible to use an app is warranted. OBJECTIVE: The goal of the research is to assess if it is feasible to use a mobile phone app for promoting and monitoring patients' adherence to a heart-healthy lifestyle after CR. METHODS: The study included an experimental, pre-post single-arm trial lasting for 12 weeks. All patients received access to an app aimed to guide individuals to change or maintain a heart-healthy lifestyle. During the study period, patients received weekly, individualized monitoring through the app, based on their own goals. Feasibility outcomes assessed were recruitment rate, adherence to the app, resource requirements, and efficacy regarding capability to detect a change in quality of life, health status, and perceived goal achievement as well as evaluating ceiling and floor effect in these outcomes. Criteria for success were preset to be able to evaluate whether the app was feasible to use in a potential future RCT. RESULTS: In total, 71% (17/24) of the patients who completed CR were eligible for a potential RCT as well as for this study. All 14 patients included in the study used the app to promote preventive activities throughout the study. Satisfaction with the technology was high, and the patients found the technology-based follow-up intervention both useful and motivational. Ceiling effect was present in more than 20% of the patients in several domains of the questionnaires evaluating quality of life (36-Item Short Form Health Survey and COOP/WONCA functional health assessments) and health status (EQ-5D). Overall self-rated health status (EuroQol Visual Analog Scale) and perceived goal achievement were found to be outcomes able to detect a change. CONCLUSIONS: Individual follow-up through an app after attendance in CR is feasible. All patients used the app for preventive activities and found the app both useful and motivating. Several points of guidance from the patients in the study have been adopted and incorporated into the final design of the RCT now in the field.

Implementation and evaluation of the Norwegian Ullevaal model as a cardiac rehabilitation model in primary care.

PURPOSE: To describe the Norwegian Ullevaal model, customised for cardiac patients in primary care, and to evaluate the feasibility of the model through patient outcomes after the 12 week outpatient cardiac rehabilitation programme. MATERIALS AND METHODS: A descriptive interventional cohort study with pre-post design. Patients referred to cardiac rehabilitation (n = 273) were enrolled. Group-based high-intensity interval training was offered twice weekly. The primary outcome measure was change in peak oxygen uptake. Quality of life was measured using the COOP-WONCA questionnaire. RESULTS: A total of 87% completed the 12 weeks exercise based rehabilitation programme and there were no adverse events during testing or exercise training. Peak oxygen uptake improved significantly from 31.6 ± 7.5 to 34.1 ± 7.8 ml/kg/min. Mean difference was 4.1 ml/kg/min (95% confidence interval, 3.74.5). COOP-WONCA was significantly improved in all domains. CONCLUSIONS: The Norwegian Ullevaal model was effective and safe, and resulted in significant and clinically meaningful improvements in cardiopulmonary fitness and quality of life. Implications for rehabilitation Cardiac rehabilitation programmes giving at least 3.5 ml/kg/min improvements of peak oxygen uptake are shown to be beneficial. The detailed description of the Norwegian Ullevaal model, applied as a cardiac rehabilitation programme in primary care, may help clinicians with planning and initiating of group-based high intensity cardiac rehabilitation, as well as implementing evidence based science into practice. The findings from this study provide preliminary evidence in support of alternative exercise prescriptions compared to present modalities for cardiac rehabilitation in primary care.

The Effectiveness of Smartphone Apps for Lifestyle Improvement in Noncommunicable Diseases: Systematic Review and Meta-Analyses.

BACKGROUND: Noncommunicable diseases (NCDs) account for 70% of all deaths in a year globally. The four main NCDs are cardiovascular diseases, cancers, chronic pulmonary diseases, and diabetes mellitus. Fifty percent of persons with NCD do not adhere to prescribed treatment; in fact, adherence to lifestyle interventions is especially considered as a major challenge. Smartphone apps permit structured monitoring of health parameters, as well as the opportunity to receive feedback. OBJECTIVE: The aim of this study was to review and assess the effectiveness of app-based interventions, lasting at least 3 months, to promote lifestyle changes in patients with NCDs. METHODS: In February 2017, a literature search in five databases (EMBASE, MEDLINE, CINAHL, Academic Research Premier, and Cochrane Reviews and Trials) was conducted. Inclusion criteria was quantitative study designs including randomized and nonrandomized controlled trials that included patients aged 18 years and older diagnosed with any of the four main NCDs. Lifestyle outcomes were physical activity, physical fitness, modification of dietary habits, and quality of life. All included studies were assessed for risk of bias using the Cochrane Collaboration`s risk of bias tool. Meta-analyses were conducted for one of the outcomes (glycated hemoglobin, HbA1c) by using the estimate of effect of mean post treatment with SD or CI. Heterogeneity was tested using the I2 test. All studies included in the meta-analyses were graded. RESULTS: Of the 1588 records examined, 9 met the predefined criteria. Seven studies included diabetes patients only, one study included heart patients only, and another study included both diabetes and heart patients. Statistical significant effect was shown in HbA1c in 5 of 8 studies, as well in body weight in one of 5 studies and in waist circumference in one of 3 studies evaluating these outcomes. Seven of the included studies were included in the meta-analyses and demonstrated significantly overall effect on HbA1c on a short term (3-6 months; P=.02) with low heterogeneity (I2=41%). In the long term (10-12 months), the overall effect on HbA1c was statistical significant (P=.009) and without heterogeneity (I2=0%). The quality of evidence according to Grading of Recommendations Assessment, Development and Evaluation was low for short term and moderate for long term. CONCLUSIONS: Our review demonstrated limited research of the use of smartphone apps for NCDs other than diabetes with a follow-up of at least 3 months. For diabetes, the use of apps seems to improve lifestyle factors, especially to decrease HbA1c. More research with long-term follow-up should be performed to assess the effect of smartphone apps for NCDs other than diabetes.

Long-Term Results of High-Intensity Exercise-Based Cardiac Rehabilitation in Revascularized Patients for Symptomatic Coronary Artery Disease.

Exercise capacity is a strong predictor of survival rate in patients with and without coronary artery disease. Exercise-based cardiac rehabilitation (CR) with improvements in the peak oxygen uptake (VO2peak) of 3.5 ml/kg/min or more has been shown to be beneficial in earlier observational studies. Long-term results on VO2peak after CR are rare. The aim of this study was to assess if a 12-week outpatient CR program including high-intensity interval training would preserve or improve VO2peak 15 months after CR entry. A total of 133 coronary patients attended the CR program (the Norwegian Ullevaal model). At baseline, at the end of the program, and after 15 months, the patients were evaluated with a cardiopulmonary exercise test, body mass index, blood pressure, self-reported exercise habits, and quality of life (the COOP-WONCA questionnaire). Long-term outcomes were available for 86 patients (65 %). The mean age was 57 ± 9 years and 87% were men. VO2peak improved significantly from baseline (31.9 ± 7.6 ml/kg/min) to program end (35.9 ± 8.6 ml/kg/min) (p <0.001), and further progress was seen at the long-term follow-up (36.8 ± 9.2 ml/kg/min) (p <0.05). COOP-WONCA was significantly enhanced in all domains (p <0.001) with a meaningful clinical improvement in "physical fitness" from baseline to long-term follow-up. In conclusion, at follow-up, the patients still exercised (mean 2.5 ± 1 times per week) and had improved or preserved their VO2peak and quality of life.