Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial

IntroductionONCO-TreC platform consists of a mobile application delivered to patients as electronic diary and a web-based dashboard managed by healthcare professionals. We aim to compare the effectiveness of ONCO-TreC electronic diary with a standard paper diary, in improving adherence to oral cancer therapy in patients with solid and haematological tumours.Methods and analysisThis is an open label, superiority, randomised controlled trial conducted in two Italian oncology units. Patients will be randomised with a 1:1 ratio to electronic or paper diary. For both groups a counsellor will be responsible for drug and diary delivery. The evaluation period will end after six cycles of therapy. The primary aim is to compare the proportion of non-adherent patients in the two arms. Adherence will be measured through pill count; anyone who takes less than 90% of the total prescribed drug dose will be considered non-adherent. Assuming a percentage of non-adherent patients to oral therapy of 40% in arm B, and a 60% reduction in this percentage in arm A, a sample of 124 patients will provide 80% power to identify an absolute difference greater than 24 percentage points using a bilateral Fisher’s exact test with a significance level of 0.05. Considering a dropout rate of 10%, approximately 136 patients will have to be enrolled. The primary analysis will be performed on the intention-to-treat population. Secondary aims are to describe the reasons for non-adherence, the level of satisfaction of patients and healthcare professionals with the paper and electronic diary, and the impact of non-adherence in terms of healthcare costs.Ethics and disseminationEthical approval was obtained from Romagna Ethics Committee (CEROM), study ID 2108, prot. n. IRST 100.28 of 10/04/2020. Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations.Protocol versionVersion 2, 6 April 2021.Trial registration numberNCT04826458.

Changes in Patient-Reported Outcome Measures With a Technology-Supported Behavioral Lifestyle Intervention Among Patients With Type 2 Diabetes: Pilot Randomized Controlled Clinical Trial

Background In the United States, more than one-third of the adult population is obese, and approximately 25.2% of those aged ≥65 years have type 2 diabetes (T2D), which is the seventh leading cause of death. It is important to measure patient-reported outcomes and monitor progress or challenges over time when managing T2D to understand patients’ perception of health and quantify the impact of disease processes or intervention effects. The evaluation of patient-reported outcome measures (PROMs) is especially important among patients with multiple chronic conditions in which clinical measures do not provide a complete picture of health. Objective This study examined the feasibility of collecting Patient-Reported Outcome Measurement Information System (PROMIS) measures, and preliminarily evaluated changes in PROMIS scores and compared the scores with standard scores of the general US population. The parent study is a pilot randomized controlled clinical trial testing three different modes (mobile health [mHealth], paper diary, and control) of self-monitoring in a behavioral lifestyle intervention among overweight or obese patients with T2D. Methods Patients with comorbid overweight or obesity and a diagnosis of T2D for at least 6 months were recruited from a diabetes education program. Participants were randomized to the following three groups: mHealth, paper diary, and control (standard of care) groups. Paper diary and mHealth experimental groups received additional behavioral lifestyle intervention education sessions, as well as tools to self-monitor weight, physical activity, diet, and blood glucose. All participants completed PROMIS-57 and PROMIS-Global Health (GH) version 1.0 questionnaires during visits at baseline, 3 months, and 6 months. The PROMIS-57 includes the following seven domains: anxiety, depression, fatigue, pain interference, physical function, satisfaction with participation in social roles, and sleep disturbance. The PROMIS-GH is composed of the following two domains: global mental health and global physical health. Results A total of 26 patients (mHealth, 11; paper diary, 9; control, 6) were included in our analysis. The study sample was predominantly African American (68%) and female (57%), with a mean age of 54.7 years and a mean BMI of 37.5 kg/m2. All patients completed the PROMIS-57 and PROMIS-GH questionnaires, and we compared the mean scores of the three groups to investigate potential differences. No relevant differences were noted across the groups. However, positive trends were noted in both intervention (mHealth and paper diary) groups in the middle (month 3) and end (month 6) of the study. Conclusions Our pilot study provides evidence for the feasibility of using PROMIS questionnaires to record important components of T2D-related symptoms among overweight or obese individuals. The results from our study support the use of PROMIS questionnaires to provide clinicians and researchers with a benchmark for assessing the overall need for symptom management and determining the success or challenges of an intervention. Trial Registration ClinicalTrials.gov NCT02858648; https://clinicaltrials.gov/ct2/show/NCT02858648

Changes in Patient-Reported Outcome Measures With a Technology-Supported Behavioral Lifestyle Intervention Among Patients With Type 2 Diabetes: Pilot Randomized Controlled Clinical Trial (Preprint)

BACKGROUND In the United States, more than one-third of the adult population is obese, and approximately 25.2% of those aged ≥65 years have type 2 diabetes (T2D), which is the seventh leading cause of death. It is important to measure patient-reported outcomes and monitor progress or challenges over time when managing T2D to understand patients’ perception of health and quantify the impact of disease processes or intervention effects. The evaluation of patient-reported outcome measures (PROMs) is especially important among patients with multiple chronic conditions in which clinical measures do not provide a complete picture of health. OBJECTIVE This study examined the feasibility of collecting Patient-Reported Outcome Measurement Information System (PROMIS) measures, and preliminarily evaluated changes in PROMIS scores and compared the scores with standard scores of the general US population. The parent study is a pilot randomized controlled clinical trial testing three different modes (mobile health [mHealth], paper diary, and control) of self-monitoring in a behavioral lifestyle intervention among overweight or obese patients with T2D. METHODS Patients with comorbid overweight or obesity and a diagnosis of T2D for at least 6 months were recruited from a diabetes education program. Participants were randomized to the following three groups: mHealth, paper diary, and control (standard of care) groups. Paper diary and mHealth experimental groups received additional behavioral lifestyle intervention education sessions, as well as tools to self-monitor weight, physical activity, diet, and blood glucose. All participants completed PROMIS-57 and PROMIS-Global Health (GH) version 1.0 questionnaires during visits at baseline, 3 months, and 6 months. The PROMIS-57 includes the following seven domains: anxiety, depression, fatigue, pain interference, physical function, satisfaction with participation in social roles, and sleep disturbance. The PROMIS-GH is composed of the following two domains: global mental health and global physical health. RESULTS A total of 26 patients (mHealth, 11; paper diary, 9; control, 6) were included in our analysis. The study sample was predominantly African American (68%) and female (57%), with a mean age of 54.7 years and a mean BMI of 37.5 kg/m². All patients completed the PROMIS-57 and PROMIS-GH questionnaires, and we compared the mean scores of the three groups to investigate potential differences. No relevant differences were noted across the groups. However, positive trends were noted in both intervention (mHealth and paper diary) groups in the middle (month 3) and end (month 6) of the study. CONCLUSIONS Our pilot study provides evidence for the feasibility of using PROMIS questionnaires to record important components of T2D-related symptoms among overweight or obese individuals. The results from our study support the use of PROMIS questionnaires to provide clinicians and researchers with a benchmark for assessing the overall need for symptom management and determining the success or challenges of an intervention. CLINICALTRIAL ClinicalTrials.gov NCT02858648; https://clinicaltrials.gov/ct2/show/NCT02858648

Promotion of Healthy Nutrition and Physical Activity Lifestyles for Teenagers: A Systematic Literature Review of The Current Methodologies

Amid obesity problems in the young population and apparent trends of spending a significant amount of time in a stationary position, promoting healthy nutrition and physical activities to teenagers is becoming increasingly important. It can rely on different methodologies, including a paper diary and mobile applications. However, the widespread use of mobile applications by teenagers suggests that they could be a more suitable tool for this purpose. This paper reviews the methodologies for promoting physical activities to healthy teenagers explored in different studies, excluding the analysis of different diseases. We found only nine studies working with teenagers and mobile applications to promote active lifestyles, including the focus on nutrition and physical activity. Studies report using different techniques to captivate the teenagers, including questionnaires and gamification techniques. We identified the common features used in different studies, which are: paper diary, diet diary, exercise diary, notifications, diet plan, physical activity registration, gamification, smoking cessation, pictures, game, and SMS, among others.

Feasibility of a Persuasive mHealth Behavioural Change Intervention in Promoting Physical Activity in the Workplace (Preprint)

BACKGROUND Employees in the office setting are more likely to remain physically inactive. Physical inactivity has become one of the major barriers to overcoming the risk of anxiety, depression, coronary heart disease, certain cancers, and type 2 diabetes. Currently, there is a gap in mobile health (mHealth) applications (apps) for workers to promote physical activity (PA) in the workplace. Studies on behaviour change theories have concluded that health applications generally lack the use of theoretical constructs. OBJECTIVE The objective was to study the feasibility of a persuasive application aimed at encouraging PA among employees and to understand the motivational aspects behind the implementation of mHealth apps among office workers. METHODS A four-week study with a mixed-method (quantitative and qualitative) design was conducted with office-based employees in four countries: (1) Oulu, Finland; (2) Carlow, Ireland; (3) London, United Kingdom; and (4) Dhaka, Bangladesh. Out of 22O invited participants (experimental group N=115, and control group N=105), the original study population of 84 participants (experimental group N=56, and control group N=28) consisted of working-age volunteers working in an office setting. Participants used two different interventions: the experimental group used an mHealth app for PA motivation, and the control group used a paper diary. The purpose was to motivate employees to engage in healthier behaviour regarding the promotion of PA in the workplace. A user-centered design (UCD) process was followed to design, develop, and evaluate the mHealth app, incorporating self-determination theory (SDT) and using game elements. The paper diary had no specific theory-driven approach, design technique, or game elements. RESULTS The compliance for the app usage remained relatively low, 27 participants (N=20 experimental; N=7 control group) completed the study. The results of the participants supported the original hypothesis that the mHealth app helped to increase physical activity in comparison to paper diary (P=0.033), i.e., promoting daily walking in the workplace. The mHealth app supported two of the basic SDT psychological needs – autonomy (P=0.004) and competence (P=0.014) – but not the needs of relatedness (P=0.535). CONCLUSIONS The SDT-based mHealth application resulted in motivating employees to increase their physical activity in the workplace. However, the compliance of the app usage remained low. Future research should further develop the app based on the user feedback and test it in a larger sample.

Viewing diaries in an age of new media: An exploratory analysis of mobile phone app diaries versus paper diaries

This exploratory study inquires into the validity and reliability of dedicated mobile phone diary applications. We developed Watchy, a dedicated mobile viewing diary application, and compared users’ compliance and usage patterns with those of users of the paper viewing diaries. Participants received paper diaries or installed mobile diary apps, with or without daily reminders, to document their viewings over a 4-day period. Documentation was more extensive in the smartphone app with reminder group compared to the paper diary group. Reminders increased documentation rates. Extent of documentation decreased as the experiment progressed for mobile app users. Findings suggest that mobile viewing diaries are an important tool for viewing studies, yet their use requires careful planning.

Mobile Application Vs. Paper Pictorial Blood Assessment Chart to Track Menses in Young Women: A Randomized Cross-over Design

Background Heavy menstrual bleeding (HMB) is the most common symptom for women with bleeding disorders. Major barriers to performing research in this field are difficulties in quantifying and tracking changes in menstrual bleeding, particularly in adolescents. The Pictorial Blood Assessment Chart (PBAC) score is often used to quantify severity of menstrual bleeding1. However, the traditional paper diary PBAC score is fraught with recall bias and compliance issues in adolescents. Utilizing mobile applications (apps) has great potential for improving health by assisting with behavior modification and disease self-management. Additionally, mobile apps can serve as a valuable medical research tool by facilitating rapid reporting. Objectives We developed a mobile app version of the PBAC score to enable adolescents to report and quantify menstrual bleeding. We evaluated patient satisfaction and compliance with mobile app reporting as compared to paper reporting. We hypothesized that adolescents would be compliant with mobile app reporting and would prefer this method over paper reporting. Methods This study was a randomized cross-over study of 25 post-menarchal females ages 13-21 years seen in the Hematology Clinics at Nationwide Children's Hospital, Columbus, Ohio. Inclusion criteria included: history of regularly occurring menstrual cycle and possession of a mobile application capable device (smart phone) with continuous service expected. Non-English speaking patients and patients intending to start a hormonal agent that may fully suppress menstrual bleeding were excluded. Subjects agreed to track menstrual bleeding in two consecutive menstrual cycles and were randomized to using the PBAC paper diary or the PBAC mobile app format first. At the end of each cycle, a 10-point response scale satisfaction questionnaire and a system usability scale (mobile app only) assessed the acceptability of the format of the diary used. Weekly email reminders were sent in both groups. Mobile device notifications and reminders were used in the mobile app group. To compare the satisfaction survey results, the Hills and Armitage method for analyzing cross-over data was used which included evaluation of period effect, group effect, and their interaction using a series of independent t-tests. Results The 25 subjects enrolled had a median age of 15 years (range 13-21 years). Eleven (44%) had identified bleeding disorders. Twenty-two (88%) could use phones in school. Subjects' PBAC scores did not have significant variability between the paper diary (median PBAC=95) and the mobile app (median PBAC=114). There was a median number of 2 entry times per day in both groups. There was no significant difference in the number of app entries subjects reported to study staff and the actual number recorded in the app. For the mobile app, twenty subjects (80%) had high compliance for reporting bleeding symptoms (app entries for >80% of cycle duration). There were no subjects with low compliance (app entries for <50% of cycle duration). All paper diaries received by study staff met definition for high compliance. The most common reasons subjects listed for missing a daily entry were 1) forgetting to enter data or 2) app not working. Results of the cross-over analysis showed that subject satisfaction was significantly higher for mobile app (mean satisfaction score of 9.5/40 with 4/40 being most satisfied) than for the paper diary (mean satisfaction score of 17.8/40) (p <0.001). Twenty (80%) subjects preferred the mobile app over the paper diary. There was no significant period effect or group by period interaction. Discussion This study demonstrated that a PBAC mobile app as compared to the PBAC paper diary was the preferred method of recording menstrual bleeding in adolescents and demonstrated feasibility as a research data collection tool. The app received stronger satisfaction scores and overall compliance was high. A PBAC mobile app is unique compared to publicly available apps because it allows girls and women to quantify their heaviness of flow during menses. Most menstrual tracking apps only track length of cycles or use qualitative assessments of bleeding. In a clinical setting, data from the PBAC app can allow providers to see real-time bleeding symptoms allowing for adjustments in therapy. 1Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol 1990:97(8):734-739. Disclosures No relevant conflicts of interest to declare.